Icmr

Guidelines for
Good Clinical Laboratory Practices
(GCLP) 2021
Compiled by: Dr. Monika Pahuja
Edited by: Dr. Puneet K. Nigam and Dr. Vijay Kumar

ICMR, New Delhi

Good Clinical Laboratory Practices Guidelines, 2021
2nd edition
© Indian Council of Medical Research 2021. All rights reserved
Publications of the ICMR can be obtained from ICMR-HQ,
Division of Basic Medical Sciences, Indian Council of Medical Research,
Ansari Nagar, New Delhi, India.
Request for permission to reproduce or translate ICMR publications – whether for sale
or for non-commercial distribution – should be addressed to ICMR-Hq at the above
address.
Care has been taken to present the information accurately, however the reader is urged to
check latest notifications/rules/regulations by GOI from time to time.
The responsibility for the interpretation and use of the material lies with the reader.
In no event shall ICMR be liable for damages arising from its use.
 FOREWORD

Globally, in the last few decades there has been a rapid expansion in the different
branches of health care services, as well as in the field of medical research. Consumer
awareness and expectation of health care have simultaneously improved with increasing
demands for high quality care, including laboratory services. It is well recognized that
laboratory quality will significantly improve if the entire process is addressed in the
quality system. Towards this goal, the laboratories should meticulously implement Good
Clinical Laboratory Practices (GCLP) that will ensure timely and accurate processing
of biological samples enabling early and accurate diagnosis and patient safety leading
to desired clinical outcomes.

With the objective of promoting uniformity in maintaining quality of laboratory

services, the Indian Council of Medical Research released the first GCLP guidelines
in the year 2008. Keeping in view of recent advances, the ICMR has now revised the
2008 document. The revised Guidelines for Good Clinical Laboratory Practices
2021 aim to establish minimum criteria which should be followed by clinical and
research laboratories involved in examining human samples, in routine healthcare
delivery and clinical research, respectively. GCLP compliance will certainly empower
clinical laboratories and clinical researchers to provide data that are reliable. Adoption
of these GCLP guidelines by laboratories in public sector, private sector and research
institutions will be a significant step forward in the betterment of health care services
and health research in India.

The efforts of the team of scientists and experts from ICMR and from other institutions
who worked meticulously in bringing out the Guidelines for GCLP 2021 deserve
appreciation.

Prof. A S Kanagasabapathy
Chairman, Drafting/Advisory Committee
Former Prof. & Head,
Deptt. of Clinical Biochemistry
Christian Medical College, Vellore
 PREFACE

Over the years, clinical laboratories have gained tremendous importance in health care
services. Laboratory investigations are essential for medical diagnosis in patient care as
well as medical research. Reliability of laboratory data/report is therefore of paramount
importance. Good Clinical Laboratory Practices (GCLP) is essential to be implemented
in the field of medical research and health care services to ensure reliability of laboratory
data. Keeping this in view, ICMR constituted an Advisory Committee to develop
the Guidelines for GCLP in the year 2008. This document has now been revised as
Guidelines for Good Clinical Laboratory Practices 2021 to be adopted uniformly in
medical laboratories involved in clinical research and/or patient care in India.

One major addition in the scope of updated guidelines is the inclusion of clinical research
involving human participants. The guidelines are also projected to establish facilities
with evolving strategies in pre-examination and examination processes of samples from
clinical research and testing laboratories to assure the quality, reliability and integrity
of the data generated.

The directives require that guidelines for compliance monitoring procedures for GCLP
and the guidelines for conduct of test facility inspection and study audit must be followed
periodically to ensure reliability and integrity of data generated by laboratories.
ICMR is expected to play a lead role in providing support and training activities to all
medical research institutions, universities and clinical research laboratories to promote
uniform adoption of these guidelines which will enable in improving the safety and
integrity of test results and to follow the quality standards, ethical conduct and regulatory
compliance as mandated by GCLP guidelines.

Dr. Vijay Kumar
Former Scientist G and Head,
Division of Basic Medical Sciences,
Indian Council of Medical Research (ICMR)
 ACKNOWLEDGEMENT

The revised Good Clinical Laboratory Practices (GCLP) Guidelines, 2021 is an

ardent, complex task taken up by a drafting committee. We extend a sincere thanks
to Prof. Kanagasabapathy for his esteemed chairmanship and guidance in building
up this document. This could not have been possible without the continued support
and directions from Dr. Shalini Singh as the team led by her, had prepared the first
version of the guidelines on Good Clinical Laboratory Practices (GCLP), 2008 that
made our task of bringing the 2nd edition easier. Our special thanks to Dr. Bikash Mehdi,
Dr. Arti kapil, Dr. B.K. Rana, Dr. Usha Aggarwal, Dr. R. Lakshmi, Dr. Purva Mathur
and Dr. Heena Tabassum for helping us to draft the document as per the current clinical
scenarios and in accordance with existing rules and regulations. The document would not
have been complete without important inputs on various aspects of clinical laboratory
practices provided by Dr. Puneet K. Nigam. We also acknowledge the inputs from
Dr. Ruchika Gupta and Dr. Dinesh Kumar in compilation of document. ICMR gratefully
acknowledge the contributions made by various stakeholders for their comments and
suggestions on the draft guidelines and shaping for its finalization. Sincere thanks to
team ICMR including Sh. G.S. Sandhu, Sh. Amal Verma, and Ms. Shivani Bhola for
necessary administrative and logistics arrangements for successfully holding drafting
committee meetings. The patronage of Prof. Balram Bhargava, Secretary, Department
of Health Research and DG, ICMR is deeply acknowledged

Dr. Monika Pahuja

Scientist ‘C’
Division of Basic Medical Sciences,
Indian Council of Medical Research (ICMR)
CONTENTS

ABBREVIATIONS i-ii
DEFINITIONS iii-vi
Chapter-1 INTRODUCTION 1
Chapter-2 SCOPE 2
Chapter-3 LEVELS OF LABORATORIES 3-5
3.1 Primary Level 4
3.2 Secondary Level 4
3.3 Tertiary Level 4
3.4 Reference Laboratories, Research Laboratories 5
and Specific Disease Reference Laboratories
3.5 For Collection Centres 5
Chapter-4 INFRASTRUCTURE 6
Chapter-5 PERSONNEL, TRAINING AND DEVELOPMENT 7-12
5.1 General 7
5.2 Personnel 8
5.3 Training 9
Chapter-6 EQUIPMENT 12-15
Chapter-7 REAGENTS AND MATERIALS 15
Chapter-8 PRE EXAMINATION PROCESS 17-18
8.1 Patient Preparation 17
8.2 Primary Sample Collection 17
8.3 Primary Sample Collection Device 17
8.4 Samples of Clinical Research/Trial 17
8.5 Sample Labeling and Documentation 18
8.6 Requisition Form/Test Request Form 18
8.7 Transportation of Samples 18
Chapter-9 SAMPLE ACCEPTANCE/REJECTION 19
Chapter-10 EXAMINATION PROCESSES 20-21
10.1 General 20
10.2 Examination Procedures 21
10.3 Performance characteristics 21
Chapter-11 RELEASE OF TEST RESULTS 22
 GCLP Guidelines 2021

Chapter-12 SAMPLE STORAGE/DISPOSAL 22-23

12.1 Sample storage 22
12.2 Sample/Chemical/e-waste disposal 23
Chapter-13 SAFETY IN LABORATORIES 23-34
13.1 General Safety Measures 23
13.2 Laboratory Safety Chemical Hygiene Plan 24
13.3 Laboratory Hygiene and Sanitation 25
13.4 Personal Hygiene 26
13.5 Electrical safety 26
13.6 Biosafety Precautions 26
13.7 Biological safety cabinets (BSCs) 34
Chapter-14 ETHICAL CONSIDERATIONS 34
Chapter-15 QUALITY MANAGEMENT 36
Chapter-16 INTERNAL QUALITY CONTROL 37-39
16.1 IQC for Quantitative Tests 38
16.2 IQC for Qualitative Tests 39
16.3 Reagent Lot Verification 39
Chapter-17 EXTERNAL QUALITY ASSESSMENT/ PROFICIENCY TESTING 40
Chapter-18 INTERNAL AUDIT 41
Chapter-19 TECHNICAL AUDIT CHECKLIST 41
Chapter-20 RISK MANAGEMENT 42
Chapter-21 QUALITY INDICATORS 42
Chapter-22 DATA MANAGEMENT 44-47
22.1 Data integrity 44
22.2 Confidentiality 44
22.3 Data Security 45
22.4 Laboratory Record 46
References 48
Annexure 1-7 50-56
Figure 1-2 57-58
ABBREVIATIONS
AERB Atomic Energy Regulatory Board
AMR Analytical Measurement Range
APAC Asia Pacific Accreditation Cooperation
BARC Bhabha Atomic Research Centre
BSC Biological Safety Cabinet
CHC Community Health Centre
CHP Chemical Hygiene Plan
CLSI Clinical and Laboratory Standards Institute
CRR Clinical Reportable Range
CV Coefficient of Variation
EC Ethics Committee
ELISA Enzyme-Linked Immunosorbent Assay
EQA External Quality Assessment
FRU First Referral Unit
GCP Good Clinical Practice
GMT Good Microbiological Techniques
HEPA High-Efficiency Particulate Air
HIS Hospital Information System
HIV Human Immunodeficiency Virus
IDSP Integrated Disease Surveillance Program
IPD Inpatient Department 
IQ Installation Qualification
IQC Internal Quality Control
IRL Intermediate level Reference Laboratory
ISO International Organization for Standardization 
LIS Laboratory Information System
MRA Mutual Recognition Agreement

i
 GCLP Guidelines 2021

NABL National Accreditation Board for Testing and Calibration Laboratories

NPL   National Physical Laboratory
NRL National Reference Laboratory
OPD Out Patients Department
OQ Operational Qualification
PHC Primary Health Centre
PPE Personal Protective Equipment
PQ Performance Qualification
QA Quality Assurance
QC Quality Control
QMS Quality Management System
QS Quality System
RNTCP Revised National TB Control Program
RPR Rapid Plasma Reagin
RTI Reproductive Tract Infections
SDI Standard Deviation Index
SDS Safety Data Sheet
SI International System of Units
SOP Standard Operating Procedure
SRL State Reference Laboratory
STDs Sexually Transmitted Diseases
TDM Therapeutic Drug Monitoring
UID Unique Identification Number

ii
DEFINITIONS
Analytical sensitivity: The assay’s ability to detect very low concentrations of a given
substance in a biological specimen.

Analytical specificity: Refers to the ability of an assay to measure particular organism

or substance, rather than others, in a sample.

Batch No.: Concentration, specificity, pH, Impurities, etc. of the various components
varies in different batches thus information of batch no., date of manufacturing and date
of expiry of reagent/kits should be clearly mentioned on the label.

Bias: Difference between the expectation of a test result or measurement result and a
true value.

Biological reference Interval: Specified interval of the distribution of values taken

from a biological reference population.

Calibration: The set of operations that establish, under specified conditions, the
relationship between values of quantities indicated by a measuring instrument or
measuring system, or values represented by a material measure or a reference material,
and the corresponding values realized by standards.

Competence: Demonstrated ability to apply knowledge and skills.

Critical interval: Interval of examination results for an alert (critical) test that indicates
an immediate risk to the patient of injury or death.

Examination: Set of operations having the object of determining the value or

characteristics of a property.

External Quality Assessment/ Proficiency Testing (EQA/PT): Refers to a system in

which the performance of a laboratory is assessed periodically and retrospectively by
an independent external agency to indicate to the any shortcomings in the laboratory’s
performance through external Quality Assessment (EQA) program/ Proficiency
Testing.

Internal Quality Control (IQC): Refers to the set of procedures undertaken by the
laboratory personnel for the continuous and immediate monitoring of laboratory work
in order to decide whether the results are reliable enough to be released.

iii
 GCLP Guidelines 2021

Investigator: The individual responsible for the conduct of the clinical trial whose role
is as defined by ICH GCP.

Laboratory Director: Person(s) with responsibility for, and authority over, a

laboratory.

Measurement Error: To describe the difference between the Laboratory measurement

and the true value of the measurand.

Measuring Range: Range of concentrations within which the assay is accurate and
precise should be documented.

Outlier: The observation in a sample, so far separated in value from the remainder
as to suggest that is may be from a different population, or the result of an error in
measurement. (ISO 3534-1).

Post-examination processes/post analytical phase: Processes following the

examination including review of results, retention and storage of clinical material,
sample (and waste) disposal, and formatting, releasing, reporting and retention of
examination results.

Precision: Closeness of agreement between independent test/measurement results

obtained under stipulated conditions. For numerical expression of precision, the term
“Imprecision” is used, which is the ‘dispersion of results of measurements obtained
under specified conditions.’

Pre-examination processes/pre analytical phase: Processes that start, in

chronological order, from the clinician’s request and include the examination request,
preparation and identification of the patient, collection of the primary sample(s) and
transportation to and within the laboratory, and end when the analytical examination
begins.

Primary Samples Specimen: Discrete portion of a body fluid, breath, hair or tissue
taken for examination, study or analysis of one or more quantities or properties assured
to apply for the whole.

Quality Control (QC): Process of monitoring and evaluating the performance of work
by measuring that performance against established standards.

iv
 GCLP Guidelines 2021

Quality Assurance (QA): All planned or systematic actions necessary to provide

adequate confidence that a service or product will satisfy given requirements for
quality. QA is the comprehensive term that refers to all aspects of operation starting
from preparation of the patient to sample collection, sample analysis, recording of the
result and its dispatch.

Quality Management System: It includes all activities of the overall management

function that determine quality policy objectives, implement them by means such as
quality planning, quality control, quality assurance and quality improvement within the
system.

Quality Manual: The Quality Manual is the overall guiding document that defines the
quality system through policies established by the laboratory.

Raw Data: All original records and documentation, or verified copies of these,
generated by observations and activities during the conduct of the work. They are
necessary for the reconstruction and evaluation of the reported results. Also called
“source data”.

Risk management: Risk management is an approach towards identifying and

preventing the error from occurring, thereby avoiding harm to the person.

Safety Data Sheet (SDS): All Chemicals/Reagents are graded on a scale which poses
a severe or potentially life-threatening hazard, thus MSDS of all chemicals should be
available handy to all users.

Sample: One or more parts taken from a primary sample.

Shift: Shift in the mean occur when an abrupt change is followed by six or more
consecutive QC results that fall on one side of the mean but typically within 95% range
as if clustered around a new mean. On the sixth occasion this is called a shift.

Stability/Shelf Life: The shelf life and stability data of all reagents/ kits should be
documented in agreement with the manufacturer’s specifications.

Sponsor: An individual, company, institution, or organization that takes responsibility

for the initiation, management, and/or financing of a clinical trial

Standard Operating Procedures (SOP): SOP contain step-by-step written

instructions for each procedure performed in the laboratory. These instructions are
v
 GCLP Guidelines 2021

essential to ensure that all procedures are performed consistently by everyone in the
laboratory.

Trends: Trends occur when values gradually, but continually, move in one direction
over six or more analytical runs. Trends may display values across the mean, or they
may occur only on one side of the mean. On the sixth occasion, this is determined to be
a trend and results are rejected.

Trial protocol: The overall study protocol approved by the sponsor which describes the
entire activities which make up the study.

Uncertainty of Measurement: Is the expression used to represent the unavoidable

error. It is the foremost responsibility of the laboratory to evaluate the reliability and
quantify the unavoidable laboratory error for every analyte.

Validation: It is the process of confirmation, through the provision of objective

evidence, that the requirement for a specific intended use or application has been
fulfilled

Verification: It refers to the laboratory’s confirmation of the performance of equipment

based on given specifications or requirements. Also, confirms that the instrument is
working correctly for its intended purpose.

vi
 GCLP Guidelines 2021

1.0 INTRODUCTION

All laboratories engaged in testing of biological samples need to establish

confidence in the quality and reliability of the results of these tests. These
expectation are fulfilled by following Good Laboratory Practices (GLP) which are
a set of principles that define a quality system concerned with the organisational
process and the conditions under which laboratory studies are planned, performed,
monitored, recorded, archived and reported. It is intended to promote quality test
data.

Similarly, for relying on conclusions drawn from the clinical data there is a need
to follow Good Clinical Practices (GCP) which are standards for the design,
conduct, performance, monitoring, auditing, recording, analysing, and reporting of
clinical trials that provide assurance that the data and reported results are credible
and accurate, and that the rights, integrity, and confidentiality of trial subjects
are protected.  Clinical trials should be conducted in accordance with the ethical
principles that have their origin in the Declaration of Helsinki, and that are consistent
with GCP and the applicable regulatory requirement(s).

Implementation of GLP principles for the examination of clinical samples forms

the basis of Good Clinical Laboratory Practices (GCLP). GCLP aims to ensure
timely and accurate processing of biological samples enabling early and accurate
diagnosis and patient safety leading to desired clinical outcomes. The Indian Council
of Medical Research (ICMR) released the first GCLP guidelines in the year 2008
which have now been revised in view of recent advances.

Recently, considering the wide spectrum and potential for clinical research in our
country, ICMR released the National Ethical Guidelines for Biomedical and Health
Research involving Human participants in 20171. To ensure that all researchers
follow these ethical principles, Ministry of Health and Family Welfare, Government
of India had notified the New Drugs and Clinical Trials Rules-2019, that came into
force from 19th March 20192. Under the Rules, Chapter IV entitled “Ethics Committee
for biomedical and health research” states that Ethics Committees reviewing
biomedical and health research should register with the authority designated by the

1
 GCLP Guidelines 2021

Central Government in the Ministry of Health and Family Welfare, Department of

Health Research (DHR).

All Clinical research involving human participants should be conducted in

accordance with the basic and general ethical principles. The researcher and the
team are responsible for protecting the dignity, rights, safety and well-being of the
participants enrolled in the study. They should have the appropriate qualifications
and competence in research methodology and should be aware of and comply
with the scientific, medical, ethical, legal and social requirements of the research
proposal.

The proposed revised guidelines for Good Clinical Laboratory Practices (GCLP),
2021 aim to establish minimum criteria which should be followed by clinical and
research laboratories involved in examining human samples, in routine healthcare
delivery and clinical research, respectively, in addition to internationally accepted
guidelines. The intent of GCLP guidelines is that when laboratories adhere to this
process, it ensures the quality and integrity of data, allows accurate reconstruction of
experiments, monitors data quality and allows comparison of test results regardless of
performance location. GCLP compliance empowers clinical laboratories and clinical
researchers to provide data/reports that are reliable and reproducible.

In India, National Accreditation Board for Testing and Calibration Laboratories

(NABL) has been providing accreditation services to medical laboratories based
on International Standard (ISO 15189: 2012) which specifies requirements for
competence and quality that are particular to medical laboratories3.

The laboratories should adhere to requisite regulatory, national and state regulations,
as applicable.

2.0 SCOPE
All clinical laboratories wherein human samples are processed, may be tested
under the following disciplines (but not limited to) for diagnosis, patient care,
disease control and clinical research should follow Good Clinical Laboratory
Practices:

2
 GCLP Guidelines 2021

2.1 Microbiology and Infectious disease Serology

2.2 Haematology and Blood Banking
2.3 Molecular Biology and Molecular Pathology
2.4 Clinical Pathology
2.5 Clinical Biochemistry-routine and special (TDM, Immunoassays)
2.6 Histopathology and Cytopathology
2.7 Genetics

3.0 LEVELS OF LABORATORIES

In India, the laboratory services are integrated with the 3-tier public health system at the
primary, secondary and tertiary levels. Besides these, there are Reference Laboratories,
Research Laboratories and Specific Disease Reference Laboratories to provide services
for complex and special tests. Medical laboratories as per NABL are classified4 as
below; irrespective of the place they are operating and are equally applicable to both
public and private sector:
a. Small sized: A laboratory receiving samples of up to 100 patients/participants
per day
b. Medium sized: A laboratory receiving samples of up to 101- 400 patients/
participants per day
c. Large sized: A laboratory receiving samples of more than 401-1000 patients/
participants per day
d. Very large sized: A laboratory receiving more than 1000 patients/participants
per day
e. Multiple location: A laboratory with more than one location in the same
district with same legal identity

Levels of Public health care:

Grass root level Sub Centre

Primary level Primary Health Centre (PHC)

Secondary level Community Health Centres (CHC) / Sub-district Hospital (SDH)

Tertiary Level District Hospital (DH)/ Medical College

3
 GCLP Guidelines 2021

3.1 Primary Level

Primary Health Centres5 (PHC) are basic structural and functional unit of public health
services acting as referral units for SCs and referring cases to CHCs.

3.2 Secondary level

The secondary level of health care essentially includes Community Health Centers6
(CHCs), constituting the First Referral Units (FRUs) and the Sub-district hospitals.
The CHCs act to provide referral health care for cases from PHCs and for cases in
need of specialist care approaching the centre directly. Sub-district (Sub-divisional)
hospitals are below the district and above the block level (CHC) hospitals and act
as First Referral Units for the Tehsil/Taluk/Block population in which they are
geographically located.

3.3 Tertiary level

Laboratories are equipped with advanced diagnostic and investigation facilities to
provide tertiary level health care7. These hospitals receive referrals from the primary as
well as the secondary levels.

Table-1
Levels of Primary Secondary Tertiary
laboratories
Capacity and • Appropriate • Appropriate staff • Appropriate staff strength
Infrastructure staff strength strength • Easy access to IPD and OPD
• Designated area for • Adequate space- Layout should
clinical laboratory ensure logical flow of specimens
including sample from receipt to disposal
collection and storage. • Separate and demarcated
areas for sample collection,
sample processing, hematology,
biochemistry, clinical pathology
and reporting.
Clinical Lab. • Essential • Essential Laboratory • Essential Laboratory services in
Services Laboratory services in CHC District hospital8: ICMR-NEDL,
services in and sub-district level 2019
PHC8: ICMR- hospital : ICMR-NEDL, • Facility of emergency laboratory
8

NEDL, 2019 2019 services

4
 GCLP Guidelines 2021

Levels of Primary Secondary Tertiary

laboratories
Quality • Regular internal • Monitoring of laboratory • Standard operating procedures
Assurance quality control at this level includes (SOP) should be well documented
(IQC) with both IQC and EQA and implemented
possible inter- • Appropriate training of personnel
laboratory on SOPs and guidelines
comparison • External validation of lab reports
on regular basis

All Levels of laboratories should follow biomedical and waste management guidelines
that are intended to help safe disposal of contaminated waste and safety of health
workers and the community.

3.4 Reference Laboratories, Research Laboratories and Specific Disease Reference

Laboratories
The Reference Laboratories, Research Laboratories and Specific Disease Reference
Laboratories serve a disease condition of national importance. Medical colleges,
research institutions can be designated by appropriate authority for ensuring high
standards of quality in one or more particular disease condition. The National and State/
Intermediate level Reference Laboratory (NRL/SRL or IRL) provides scientific and
technical assistance, offers counseling and expert advice on topics linked to surveillance,
standardization of diagnostic techniques and control of the disease for which the
Reference Laboratory is responsible. They may also provide scientific and technical
training for personnel and coordinate scientific and technical studies in collaboration
with other laboratories or organizations.

3.5 Collection Centres: In addition to the above-mentioned levels of laboratories, there

are separate collection facilities which do not carry out diagnostic services but only
collect samples/specimen4.

5
 GCLP Guidelines 2021

4.0 INFRASTRUCTURE
4.1 Infrastructure of the laboratory varies with the requirements of the clinical
research/services provided by the laboratory, but the basic requirements should
meet the regulatory and international standards. Infrastructure of a laboratory
directly impacts the quality of research data, efficiency and safety of laboratory
workers. The management of the laboratory is responsible for providing adequate
resource to staff, to ensure efficient working of a laboratory.

Good laboratory design should consider the following (in concordance with local
regulatory authority)-

4.1.1 Signage-signage within or outside the facility should be made available

containing the following information – Name, registration number, services
offered, working hours, contact number, fees for different tests & services.
4.1.2 Essential Health and Safety regulations- use safety signage, as applicable.
4.1.3 Emergency (fire, chemical spillage, lab accidents etc) and Disaster
management plan.
4.1.4 Uninterrupted power supply.
4.1.5 Laboratory grade water for examination purpose
4.1.6 Ventilation, environment control (temperature, humidity, magnetic field,
vibration, etc.) and lighting arrangements
4.1.7 Communication facility with referral centres
4.1.8 Transport of specimen/samples to referral centres
4.1.9 Lab areas containing carcinogens, radioisotopes, biohazards, and lasers
should be properly marked with the appropriate warning signs. 

4.2 To avoid cross contamination the basic infrastructure facilities should have
separate designated areas for (as applicable)-
4.2.1 Reception area or waiting area where requisition forms are received and
reports disbursed
4.2.2 Specimen (Primary sample) collection room/area, toilet, privacy for special
purposes e.g. semen collection, facilities for disabled persons

6
 GCLP Guidelines 2021

4.2.3 Examination work area (segregation wherever applicable)

4.2.4 Space for handling radio-active materials (as per BARC requirements)
4.2.5 Waste disposal facility including biomedical waste
4.2.6 Facility for cleaning of glassware, sterilization /disinfection
4.2.7 Area for meetings/trainings/administrative work
4.2.8 Separate area for eating and storing food, drinks etc.
4.2.9 Toilet for staff with appropriate eye wash and body wash facility

4.3 Storage
4.3.1 Specimen/Sample/slide storage facility including cold storage wherever
applicable
4.3.2 Reagents and consumables storage facility
4.3.3 Record/archive room/area

4.4 Restricted Access -Only authorized personnel should have access to examination
area and record keeping area or information systems.

4.5 Additional infrastructure facilities may be added for special tasks as and when
needed.

5.0 PERSONNEL, TRAINING AND DEVELOPMENT

5.1 General- Personnel are the most important laboratory resource. Each laboratory
should designate a head of the laboratory (Laboratory Director) who is responsible for
the overall operation and administration of the laboratory, including the employment
of competent personnel, equipment, safety, laboratory policies, quality processes, all
testing (including proficiency testing) and test reports. A Quality Manager should be
designated to independently monitor and maintain quality management system in a
regular manner. He/She should report to the management of the laboratory for the
functions related to quality management system.

The strength of staff employed should be appropriate to the level of facility and the
workload. The organizational structure of the laboratory must support an optimal
Path of Workflow9 from collection to reporting of result, by allowing processes that
yield efficient sample handling while minimizing error.

7
 GCLP Guidelines 2021

5.2 PERSONNEL
5.2.1 Laboratory Director has the principal responsibility for setting up an organization
that can support the quality system model. The Director should ensure that delegated
duties are properly performed and must be accessible to provide onsite, telephone, or
electronic consultation. The Laboratory Director is responsible for developing policies,
assigning authority and responsibility to the appropriate persons, optimizing resources,
reviewing the organizational aspects of the system for optimal functioning of quality
processes and also ensuring that personnel follow the quality policies established by the
laboratory.

5.2.2 Quality Manager assists in developing policies, quality system procedures and
facilitating and implementing the quality management system (QMS) in an independent
manner. The Quality Manager shall communicate all aspects of the quality management
system processes directly to the laboratory director or head of the laboratory. It is strongly
advised that quality manager undergoes training on current standard3. He/She may be
one of the technical personnel with additional responsibility as Quality Manager, in the
case of smaller laboratories.

5.2.3 Document Control

All original documents (master copy) should be retained in a secure area and
only controlled copies are distributed to users such as laboratory director, quality
manager and other relevant personnel. Obsolete documents should be archived as
per the retention policy guidelines. The previous original copies must be obsolete
and retained for reference. It is preferable to distribute documents in electronic
form in read only format.

5.2.4 Review of documents in QMS

All documents must be reviewed periodically/at least annually for improvements.
Laboratory personnel must be trained on the revised procedures before effective date.

5.2.5 Laboratory/Technical personnel are responsible for understanding the

organizational structure of the laboratory. The laboratory personnel shall follow

8
 GCLP Guidelines 2021

the quality policies and procedures in their daily work routine as described in the
laboratory developed quality manual. It is advised that personnel are thoroughly
oriented towards this current GCLP document as well as applicable requirements of
the current ISO 15189 Standard3.

5.3 TRAINING
Training is a process to provide knowledge and develop skills in order to meet
requirements. Personnel should be appropriately trained to achieve quality outcomes in
the laboratory and produce accurate, reliable, and timely test results.

5.3.1 Various types of training:

Broadly these trainings may be divided into induction training and on-the-job training
or a combination of these types. Training may be internal or external; trainers may be
internal or external.

The goal of the laboratory’s training program for technical personnel is to ensure that
the employees-
a) Possess the necessary knowledge, skills and abilities to perform assigned
work
b) Follow laboratory policies, procedures, and guidelines
c) Are able to perform accurate examinations
d) Acquire a working environment which is stress free and conducive for work

Induction Training: This training orients a newly joined person to the organization,
laboratory’s facility, culture, and values. Training is given at the time of joining. It
provides the newly joined person with better understanding of the role he or she is
going to play in helping the organization and laboratory achieve its goals. It should
cover applicable policies, processes and procedures and requirements. Job introduction
topics may include personnel introduction, laboratory terminology, attendance, dress
requirements, ergonomics, facility communications, computer systems, security and
privacy, and the quality management system.

9
 GCLP Guidelines 2021

On the Job Training: All laboratory personnel involved in specimen collection,

processing, examination and reporting should take GCLP training. The frequency of
this training must be sufficient to ensure that employees remain familiar with the GCLP
requirements applicable to them. The laboratory must employ an adequate number of
qualified personnel to perform all functions associated with the volume and complexity
of tasks and testing performed.

Managerial and technical personnel engaged in the conduct of laboratory testing related
to clinical research must have the education, training, and experience commensurate
with their assigned functions.

5.3.3 Evaluation of training:

• The laboratory should have a policy that refers to the program and
processes used for assessing effectiveness of trainings. Evaluation can be
done post training, after some duration to see effective implementation and
understanding.
• Evaluation must be conducted and recorded for all tasks upon completion
of an employee’s initial training, for new methods or instruments prior to
starting patient testing and prior to reporting patient results, for new and
changed processes and procedures and when personnel responsibilities
change.

5.3.4 Competence assessment:

• Laboratory should conduct periodic competence assessment of all
personnel, preferably once a year. Competency assessments should be
done to ensure that the personnel maintain their competency to perform
assigned jobs promptly, accurately and without errors.

• Competency assessments must compare employee performance against a

documented standard and clearly verify competency or lack of competency
for each evaluated task. Competency records need to identify what was
reviewed or observed, when it was reviewed or observed, who did the review
or observation, and what was the outcome.

10
 GCLP Guidelines 2021

• Individuals responsible for competency assessments should have the

education and experience to evaluate the complexity of the testing being
assessed.
• All records created for retraining and reassessments need to include the
outcome, be signed by the individual and management, and retained in the
individual’s personnel file.
• Competency assessment must include, but are not limited to:
- Direct observations of routine patient test performance, including
patient preparation, if applicable, specimen handling, processing, and
testing.
- Monitoring the recording and reporting of test results.
- Direct observation of performance of instrument maintenance and
function checks.
- Assessment of test performance through testing previously analyzed
samples, internal blind testing samples or external proficiency testing
samples.
- Review of worksheets, quality control records and preventive
maintenance records.
- Assessment of problem-solving skills.

• Personnel should be tested for visual colour discrimination. Personnel

performing testing or other tasks that require colour discrimination should be
evaluated for difficulty with visual colour discrimination. Evaluation limited
to discrimination of those coloured items pertinent to the job is sufficient.

• The laboratory management should be committed for providing

continuing professional education program and training opportunities to
laboratory personnel. Such a program, adequate to meet the needs of
all personnel, must be documented and evidence of ongoing adherence
by all laboratory personnel must be readily available. Action plan for
improvement in the training programs should be determined and revised
according to the feedback received from previous evaluations, past

11
 GCLP Guidelines 2021

performance, user feedback, complaints, audit findings and management

inputs.

• The laboratory should maintain a personal file of all personnel employed in the
laboratory.
List of information and documents for personal file
o Personal details
o Educational qualification with copy of degree/diploma, training certificates,
and awards/recognition received, experience etc.
o Registration with state authority (if applicable)
o Copy of appointment letter.
o Medical fitness certificate from registered medical practitioner in format and
information (especially ECG, chest X-ray, color blindness, immunizations
received etc.) and its regular updates.
o Performance appraisal records of periodic evaluation, if any
o Vaccination records
o Accidents/Incidents records

Training records should include the following information:

- Title of the training event
- Identity of the trainer(s)
- Items covered during the training
- Training dates
- Names of the person being trained
- An attestation including the trainee’s signature should be recorded indicating
commitment to comply with procedures as trained

• Although there are no specific retraining requirements for personnel returning

after an extended absence, the laboratory should determine training or retraining
needs individually.

6.0 EQUIPMENT
Each laboratory should prepare a list of equipment required for functioning of the
laboratory depending on the type of tests performed. Equipment includes hardware
and software of instruments, measuring systems, and laboratory information systems.
Laboratory equipment should be of adequate capacity to meet work load requirement.

12
 GCLP Guidelines 2021

Equipment should be suitably located in the laboratory so as to allow accessibility and

sequential utilization thus minimizing the need for frequent movement of manpower,
specimens or reagents. The following should be ensured:

• Equipment should be selected to meet the requirements of the laboratory in

terms of design and capacity.
• All equipment should be qualified before it is put to clinical use {Installation
Qualification (IQ),  Operational Qualification (OQ) and Performance
Qualification (PQ)}. Few small equipment are exceptions like vortex
mixture and Point-of-care testing (POCT) devices.
• All equipment should be in good working condition at all times. Periodic
inspection, cleaning and maintenance of equipment should be done.
Maintenance should be done as recommended by manufacturer or more- as
required e.g. with overuse or aging of equipment.
• An equipment log book (Annexure-1 and 2) should be maintained for
all equipment. Laboratories should maintain necessary instructions for
operation and maintenance of equipment in the form of SOP, a copy of the
same should be readily available near the equipment.
• All equipment should undergo calibration and verification. Conducting
or performing the calibration process involves applying a standard value
to the laboratory instrument and observing how it behaves. Calibration
frequency should be as defined by the manufacturer or as per norm3. In case
of examination systems such as automated analyzers the calibration should
be done by the manufacturer/company engineer. All automated examination
systems such as cell counters, clinical biochemistry auto-analyzers,
automated coagulometers and ELISA readers etc., shall be calibrated at a
regular interval as per SOPs. Raw data generated during calibration should
be maintained as a record.
• The equipment should be calibrated in a manner that metrological
traceability shall be to SI Units through a reference material or reference
procedure of the higher metrological order available. It can generally be
obtained through calibration from National Measurement Institutes i.e.

13
 GCLP Guidelines 2021

National Physical Laboratory (NPL-India) for legal metrology and Bhabha

Atomic Research Centre (BARC), Mumbai for radiological measurement
or a calibration laboratory accredited by any of the MRA partners of Asia
Pacific Accreditation Cooperation (APAC) having accreditation for the
specific scope.
• Various types of equipment may be calibrated in-house by using reference
materials or comparative techniques. In such cases, reference materials
should demonstrate traceability to SI units or the appropriate measurement
standards. Such an activity should be done only if the laboratory has the
competence and meets the applicable requirements.
• Equipment performance should be verified by running IQC material having
matrix similar to sample to be examined, as far as feasible. Outlier parameter,
root cause analysis and corrective actions record should be maintained.
• A preventive maintenance program for all equipment should be created and
implemented. This can be done by preparing a checklist/format/calendar
for equipment maintenance, as applicable. The maintenance program to be
developed in the laboratory should include the following components:
i. A preventive maintenance program for all equipment should be in
place. This involves periodic performance checks as recommended by
the manufacturer.
ii. Maintenance of a register of all equipment indicating serial numbers,
unique identification numbers and specific locations in the laboratory.
iii. There shall be provision for harmonization of instrument e.g. if 2/3
analysers are available for a test then, both should be harmonized. At
the minimum a six monthly comparison should be done if they are
used as back-up or simultaneously.
iv. All equipment to be properly checked by the qualified and trained
person to ensure safety of the users e.g. earthing check six monthly
v. Records of all break downs to be maintained.
• Maintenance contracts including warranty cards, telephone numbers of
personnel to be contacted in case of equipment malfunction should be kept

14
 GCLP Guidelines 2021

safely but within reach of the user. User manual should be readily available
for reference. The laboratory personnel should be aware of trouble shooting/
corrective measures.

6.1 Disposal of equipment

Laboratories should ensure that there are proper procedures in place for condemnation
and disposal of equipment that is unserviceable or that is no longer required. This
will take old and potentially unsafe equipment out of service, making sure hazardous
materials are properly handled and allowing availability of proper storage space as
applicable.

6.2 The Condemnation

The procedures for condemnation and disposal of obsolete equipment should be laid
down by the laboratory in the form of SOP. Criteria for condemnation and disposal of
equipment that are obsolete, unserviceable, unfit and hazardous equipment disposal
should be as per the SOP and/or the relevant existing policies or local national guidelines
for disposal as applicable.

7.0 REAGENTS, KITS AND MATERIALS

7.1 Use, maintenance and storage of reagents, kits and materials form major part
of basic infrastructure for smooth functioning of diagnostic and clinical research
laboratories.
7.1.1 All reagents, kits and materials of standard quality supplied from a reputed
supplier must be fit for the purpose of analysis viz. analytical grade, HPLC
grade, etc.
7.1.2 Quality of newly purchased reagents should be verified against suitable
control/reference material/retained sample prior to use. In-house prepared
reagents should also be checked periodically for stability and a record of the
same should be maintained and defined in SOP.
7.1.3 Reagents- Description of reagents, kits and materials in terms of name,
batch/Lot/Cat. no., date of manufacture, etc. should be available in inventory
log/register. Details relevant to usage like sensitivity, specificity, measuring
15
 GCLP Guidelines 2021

range, shelf life, label, SDS, storage and disposal should be mentioned in
the SOP.

7.1.4 Label: Labeling of reagents/bottles/containers, kits, chemicals etc. plays an

indispensable role in the safe and accurate testing. Following information
should be clearly mentioned in the label of all reagents-
• Name of the reagent
• Date of receiving/opening
• Strength or concentration
• Storage conditions
• Date of expiry
• Opened by-initial/sign

7.1.5 Storage: All reagents, consumables, stains, media, kits, and antimicrobials
should be stored as recommended by the manufacturer.

7.1.6 Preparation of working solutions: Working solutions should be prepared

within the laboratory as per SOP and following information should be
mentioned on the label-
 Name of the solution
 Date of preparation
 Content of the solution
 Strength or concentration
 Storage conditions
 Expiration date
 Prepared by (name)

7.1.7 Disposal of Unusable/Expired Reagent: All unused reagents, kits and

materials etc. are to be disposed as per the national and international
guidelines.

7.1.8 Medical Disposables- All Medical disposables and consumables should be

used as per the specifications of manufacturer, especially products meant
for single use should not be re-used.

16
 GCLP Guidelines 2021

7.1.9 Water Quality- should be checked for its grade and presence of interference
elements. Distilled deionised water10 should be used for testing.

7.1.10 All radio-active material should be used, stored and disposed as per the
Atomic Energy Regulatory Board (AERB) guidelines.

8.0 PRE EXAMINATION PROCESS

Pre-examination is the biggest contributor to laboratory errors, hence this phase
should get adequate focus and monitoring to ensure accurate result generation by
laboratory.

8.1 Patient preparation: Patient preparation as per the prescription or requirement is

the first important step in sample collection. If ignored, it could be a source of variation.
Some tests require that the patient be on fasting. There may also be special timing for
sample collection e.g.- blood sugar, hormone, etc.

8.2 Primary sample collection: SOP for Primary sample should be available to
all personnel at collection site and they should be well trained to follow all the steps.
Specimen collection can be done at the patient’s bedside, in the laboratory or in the
field.

8.3 Primary sample collection device: Standard precautions should be followed

during specimen collection. Specimen collection devices used should be of standard
make, if not should be verified before use. Closed system (evacuated collection
devices) of specimen collection has many advantages and is generally preferred
over syringe and needle. Specimens must be collected, labelled, handled and
transported in a manner as recommended by manufacturer of the device or the kit/test
method.

Appropriate tube/container in terms of volume, with or without anticoagulant, etc.

should be used. Specimen should be secured so that there is no leakage, spillage or
contamination.

8.4 Samples of clinical Research/Trial: In addition to the above mentioned

general requirements related to the specimen collection the following should be
adhered to-
17
 GCLP Guidelines 2021

• Appropriate counselling should be done before specimen collection and

written consent has to be taken. Attention should be paid to patient’s
sensibilities during the entire process.

All clinical samples whether is for diagnostic or clinical research should be considered
“INFECTIOUS” and handled accordingly.

8.5 Sample Labeling and Documentation: Specimen should be labelled with at

least two unique identifiers e.g.- Name, age etc. Specimen labeling using bar-codes
is an option that may reduce errors. Label may include (but not limited to) following
details-
• Patient’s name, age, gender
• Patient ID
• Tests requested
• Time and date of specimen collection

8.6 Requisition Form/Test Request Form:

• The requisition form should be completed by the doctor/health worker
requesting the tests and sent along with the specimen/patient to the
laboratory.
• It should contain the patient’s identity, age, location, date and time of
specimen collection, investigations requested and source of sample (e.g. for
culture and histopathology).
• The TRF should be signed by the phlebotomist and the patient/doctor to
indicate consent for specimen collection.
• The referring doctor should be encouraged to mention the provisional or
working diagnosis and relevant clinical and treatment history in the space
provided (Annexure-3).

8.7 Transportation of samples- When samples are collected in field or outside the
laboratory (e.g. in collection facilities), these need to be transported for analysis to
a laboratory. In all cases, transportation of samples should ensure sample integrity
and stability for obtaining right results. Transport of the samples4 should be managed
as per the SOP. Personnel handling the samples should be trained for all transport
procedures. During transport of sample following points should be taken care of-
18
 GCLP Guidelines 2021

• Analyte stability
• Temperature requirement
• Preservation (if any)
• Photosensitivity (if any)
• Integrity and stability of samples
• Special Packaging requirements (in case of shipment)
• Timeliness
• Safety of the personnel handling the sample
• Tracking System for samples (as far as possible)

9.0 sample ACCEPTANCE/REJECTION

9.1 All specimens should be checked when received in the laboratory for fitness for
testing. These checks should include appropriate container, quantity/volume (in case
of blood/urine sample), temperature on receipt, quality of sample (in case of tissue
samples), any leakage, etc. (Refer Section 11.0).
• Record should be maintained for acceptance/ rejection (with reasons and
actions specified) of all the samples received in the laboratory, as per the
predefined criteria.
• If laboratory rejects any sample, a communication should be made to the
patient/doctor and need for recollection.
• Laboratory should exercise utmost care in the collection of precious specimen
like histopathology, CSF, etc., whose recollection is either not possible or is
difficult.
• Laboratories should maintain a record of specimens which were rejected
prior to analysis. Rejection details along with reason for rejection should be
maintained (Annexure 4).

9.2 Specimen rejection details can be used by laboratories to identify the need and
areas for personnel training. For example, if specimen contamination is detected, the
containers should be checked for sterility prior to collection or for the lot/batch. This
information should be shared with the medical, nursing and other personnel engaged in
specimen collection and transportation.

9.3 Criteria for sample rejection: Specimen rejection criteria should always be
upfront mentioned in SOP’s of respective tests. Terms for rejection of samples may
include but not limited to the following-
19
 GCLP Guidelines 2021

• Unlabeled sample
• Broken or leaking tube/container
• Insufficient patient information
• Specimen label and patient name/UID on the test request form do not
match
• Haemolyzed sample (depending on the test)
• Non fasting sample (if fasting is required)
• Specimen collected in a wrong tube, wrong preservative, non-sterile
container
• Insufficient specimen volume for the test requested
• Prolonged transport time

9.4 Actions required for rejected samples:

• Inform authorized person

• Request another specimen
• Record rejected specimen
• Retain rejected specimen based on preset criteria

10.0 EXAMINATION PROCESSES

10.1 General

• The laboratory should select examination procedures which have been

verified or validated for their intended use.
• The identity of persons performing activities in examination processes shall
be recorded.
• Examination procedures (SOP) should be documented. These should be
written in a language commonly understood by the staff in the laboratory
and be available in appropriate locations.
• SOPs help to ensure uniformity, consistency, compliance with regulations,
efficiency, quality output and control over the process. The laboratory
personnel must be well trained on the SOPs.

20
 GCLP Guidelines 2021

10.2 Examination Procedures

Quality Planning (QP) is concerned with establishing and validating processes
that meet customer needs. Applies to selection and evaluation of new methods and
instruments, as well as selection and design of QC procedures.

The test procedure should include the following but not limited to-
• Name of test
• Scope of test
• Purpose of examination
• Principle and method of procedure
 Limit of detection (Examination sensitivity)
 Analytical Measurement Range (AMR)
 Specimen type, sample collection, processing and storage

• Reagents, equipment, glassware and other accessories

• Procedural steps
 Calculations
 QC procedures
 Interferences
 Biological Reference range
 Clinical significance, Inference and limitation of the test
 Critical alert values
 Hazardous materials, Precautions & Safety
 Limitations and potential sources of variation
 References

10.3 Performance characteristics of a method include the following-

• Precision
• Accuracy
• Range / Analytical Measurement Range (AMR)
• Clinical Reportable Range (CRR) – when sample is diluted to report higher
values not covered by AMR

21
 GCLP Guidelines 2021

• Biological Reference Interval (BRI)

• Analytical Sensitivity
• Analytical Specificity

11.0 RELEASE OF TEST RESULTS

Test report (Annexure-5) should include but not limited to the following:
11.1 Name and Unique Patient Identification Number
11.2 Date and Time of Specimen Collection
11.3 Date and Time of Test done and result reported
11.4 Name and address of the Laboratory
11.5 Name/Source of sample (e.g. – whole blood, urine etc.)
11.6 Test results, method, measurement units and biological reference interval or
clinical decision limit or cut-off values (as applicable)
11.7 Duly signed by authorised signatory
11.8 Authorization for amendment procedure should be specified in the SOP. All
amended reports should be released with an appropriate comment. The laboratory
should also record reason for editing data.
11.9 Laboratories should maintain a list of tests with critical values. They should
provide critical (alert) values to clinicians on telephone, e.g., – (a) Glucose value of
45 mg/dl., b) frozen section biopsy report is required while operating a patient with
suspicion of cancer, c) Growth of a particular organism in culture for early diagnosis
and treatment.
11.10 Automatic release of reports can be applied if the laboratory has the necessary
LIS/middleware capability and have competency to implement it.

12.0 SAMPLE STORAGE/DISPOSAL

12.1 Sample storage: Storage of samples e.g. – conditions, methods of storage,
stability of analyte, retention time, etc. should be followed as per the requirement of
the users and applicable national regulatory guidelines4. Every effort should be made

22
 GCLP Guidelines 2021

to retain blocks and slides in histopathology and cytopathology. If, however, they are
returned to the patient, this must be documented and records maintained.
12.2 Sample/Chemical/e-waste disposal: Samples after retention period, if
any, should be segregated in colour coded bags at source or in sharps container, as
applicable. These should be handed over to approved local biomedical waste disposal
agency11.
• Care should be taken in disposal of hazardous chemicals, if any used by the
laboratory.
• Care should be taken in disposal of computer hardware and other items.
Refer to e-waste disposal guidelines.

13.0 SAFETY IN LABORATORIES

Personnel working in laboratories may be exposed to risks from various chemicals,
infectious materials, fire hazard, electrical shock, gas leak etc. The environment is also
at risk of being contaminated by hazardous materials used and wastes generated in the
laboratory.
The laboratories should prepare their own safety manual covering the hazard and
their mitigation plan and train staff on them. Policies should outline the use of sharps,
disposal of bio-waste, reagents, sharps and other wastes generated in the laboratory in
accordance with the local and national regulations.
It is essential to train all personnel in standard precautions. A code of practice is a
listing of the most essential laboratory practices and procedures that are basic to good
microbiological technique. Safety in laboratories therefore includes protection of both
the personnel and the environment from hazardous materials.

13.1 General Safety Measures

• All laboratory personnel should be aware of the laboratory safety policies
and procedures and follow these at all times.
• List of hazardous materials used in the laboratory should be prepared. All
hazardous materials should be accounted for on a periodic basis.
• Eye wash facility should be available as “stand-alone” facility or attached to
sink.

23
 GCLP Guidelines 2021

• Biohazard symbol (Figure-1) should be used on all container/equipment

containing biohazardous material.
• Laboratory personnel should be thoroughly trained in managing fire, and
non-fire emergencies such as large spillage, gas leakage etc.
• Adequate fire extinguishers should be readily available in the laboratory.
• Accident/incident/injuries record of laboratory personnel should be
maintained and reported to the designated authority. The report should include
description of the event, factors contributing to the event and information
on first aid or other health care provided. This information can be analysed
periodically towards effectively controlling and preventing future events.
The records should be checked periodically even in the absence of fresh
entries.
• Do not chew gum, drink, smoke or eat while working in the lab. 
• Laboratory glassware should never be utilized as food or beverage containers.
• Always wear appropriate clothing: chemically resistant lab coats or aprons
are recommended.
• Handle needles, syringes and other sharps carefully. Use self-sheathing
needles whenever possible. Dispose all sharps in an appropriate sharps
container.
• Do not dispose chemicals down the drain. Most chemicals must be disposed
as hazardous waste. This practice should be implemented strictly.
• Compressed gas cylinders should be secured to prevent them from being
knocked over. Cylinders should be capped when the regulator is removed or
not in use.
• In the event of a chemical splashing into your eye(s) or on your skin,
immediately flush the affected area(s) with running water for at least 20
minutes/ eye wash facility.

13.2 Laboratory Safety Chemical Hygiene Plan (CHP): CHP is created to protect
laboratory workers from harm due to hazardous chemicals. The CHP is a written
document stating the policies, procedures and responsibilities that protect workers
from the health hazards associated with the hazardous chemicals used in that particular
workplace.
24
 GCLP Guidelines 2021

The content of the CHP was established directly from the requirements of the laboratory
standard and includes the following information:
• SOPs relevant to the safety and health considerations related to the use of
hazardous chemicals in the laboratory.
• Identification of hazards and their mitigating strategies.
• Control measures to reduce individual exposure to chemicals.
• Provisions for medical consultations and examinations.
• Laboratory procedures to be followed in case of any accident/emergency
shall require prior approval before implementation.
• Provisions for additional personnel protection for work with carcinogens,
reproductive toxins, and chemicals with high acute toxicity known as
“particularly hazardous substances.”
• Measures to fulfil the requirement that fume hoods and other protective
equipment function properly.

13.3 Laboratory Hygiene and Sanitation

Laboratory hygiene and sanitation deal with the basic upkeep, tidiness, and maintenance
of a safe laboratory. 
• Laboratory area should have restricted access. Visitors and children should
not be allowed to enter the testing area.
• Laboratory personnel should follow safe hygienic practices which include
hand washing, wearing protective clothing, gloves, eye protection etc.
• Workbench cleaning should be done before starting and after finishing work
daily with sodium hypochlorite or equivalent material.
• Equipment should be cleaned every time before starting and after finishing
work
• Basic biomedical safety training should be given to housekeeping so that
he/she must be aware of lab waste and working materials. They should be
protected against Tetanus.

25
 GCLP Guidelines 2021

• Effective Pest control should be exercised.

• All lab staff handling samples should be vaccinated against Hepatitis B and
titres measured to ensure effective protection.

13.4 Personal Hygiene

• Never smell, inhale or taste laboratory chemicals.
• Always wash hands with soap and water after removing gloves and before
leaving the work area.
• Never eat, drink, chew gum or tobacco, smoke or apply cosmetics in the
laboratory.
• Remove Personal Protective Equipment (PPE) such as gloves and lab coats
before leaving the lab.
• Remove gloves before handling common items like phones, instruments,
door knobs, etc.
• Do not block emergency showers, eye washes, exits or hallways.

13.5 Electrical safety 

Electrical safety help prevent the misuse of electronic instruments, electric shocks and
other injuries, and ensure that any damaged equipment, cords, or plugs are reported to
the appropriate authorities so that they can be repaired or replaced. 
• Earthing check to be done annually
• Make sure all electrical panels are unobstructed and easily accessible. 
• Wherever possible, avoid using extension cords.

13.6 Biosafety Precautions

Laboratory facilities are designated as Basic – Biosafety Level 1 and – Biosafety
Level 2, Containment – Biosafety Level 3, and maximum containment – Biosafety
Level 4. Biosafety level designations are based on a composite of the design features,
construction, containment facilities, equipment, practices and operational procedures
required for working with agents from the various risk groups.

26
 GCLP Guidelines 2021

Table 2. Classification of infective microorganisms by risk group

Risk Group 1 (no or low individual and community risk)
A microorganism that is unlikely to cause human or animal disease.
Risk Group 2 (moderate individual risk, low community risk)
A pathogen that can cause human or animal disease but is unlikely to be a serious
hazard to laboratory workers, the community, livestock or the environment. Laboratory
exposures may cause serious infection, but effective treatment and preventive
measures are available and the risk of spread of infection is limited.
Risk Group 3 (high individual risk, low community risk)
A pathogen that usually causes serious human or animal disease but does not
ordinarily spread from one infected individual to another. Effective treatment and
preventive measures are available.
Risk Group 4 (high individual and community risk)
A pathogen that usually causes serious human or animal disease and that can be
readily transmitted from one individual to another, directly or indirectly. Effective
treatment and preventive measures are not usually available.
*Source: Laboratory Biosafety Manual, WHO,3rd Edition, 200412

• The backbone of the practice of biosafety is risk assessment. The laboratory

director or principal investigator is responsible for ensuring that adequate
and timely risk assessments are performed, and for working closely with
the institution’s safety committee and biosafety personnel to ensure that
appropriate equipment and facilities are available to support the work being
considered. Once performed, risk assessments should be reviewed routinely
and revised when necessary, taking into consideration the acquisition of
new data having a bearing on the degree of risk and other relevant new
information from the scientific literature.
• Diagnostic and health-care laboratories (public health, clinical or hospital-
based), all should be designed for Biosafety level 2 or above. As no
laboratory has complete control
• Over the specimens it receives, laboratory workers may be exposed to
organisms in higher risk groups than anticipated.

27
 GCLP Guidelines 2021

Table 3. Summary of biosafety level requirements (Bio-safety level)

1 2 3 4
Isolation of laboratorya No No Yes Yes
Room sealable for decontamination No No Yes Yes
Ventilation:
— inward airflow No Desirable Yes Yes
— controlled ventilating system No Desirable Yes Yes
— HEPA-filtered air exhaust No No Yes/Nob Yes
Double-door entry No No Yes Yes
Airlock No No No Yes
Airlock with shower No No No Yes
Anteroom No No Yes —
Anteroom with shower No No Yes/Noc No
Effluent treatment No No Yes/Noc Yes
Autoclave:
— on site No Desirable Yes Yes
— in laboratory room No No Desirable Yes
— double-ended No No Desirable Yes
Biological safety cabinets No Desirable Yes Yes
Personnel safety monitoring capability d No No Desirable Yes
a Environmental and functional isolation from general traffic.
b Dependent
 on location of exhaust (Air must be discharged in such a way as to avoid
interference with the air balance of the cabinet or the building exhaust system)
c Dependent on agent(s) used in the laboratory.
d For example, window, closed-circuit television, two-way communication.
Source: Laboratory Biosafety Manual12

13.6.1 Basic laboratories – Biosafety Levels 1 and 2

13.6.1.1 Code of practice: This code is a listing of the most essential laboratory practices
and procedures that are basic to GMT. In many laboratories and national laboratory
program, this code may be used to develop written practices and procedures for safe
laboratory operations.

13.6.1.2 Access: The international biohazard warning symbol and sign (Figure 1)
must be displayed on the doors of the rooms where microorganisms of risk group 2 or
higher risk groups are handled. Only authorized persons should be allowed to enter the
laboratory working areas.
28
 GCLP Guidelines 2021

13.6.1.3 Personal protection: Laboratory coveralls, gowns or uniforms must be

worn at all times for work in the laboratory. Appropriate gloves must be worn for all
procedures that may involve direct or accidental contact with blood, body fluids and
other potentially infectious materials or infected animals. After use, gloves should be
removed asceptically and hands must then be washed. Personnel must wash their hands
after handling infectious materials and animals and before they leave the laboratory
working areas. Safety glasses, face shields (visors) or other protective devices must be
worn when it is necessary. Eating, drinking, smoking, applying cosmetics and handling
contact lenses is prohibited in the laboratory working areas. Storing human foods or
drinks anywhere in the laboratory working areas is prohibited.

13.6.1.4 Laboratory working areas: The laboratory should be kept neat, clean and free
of materials that are not pertinent to the work. Work surfaces must be decontaminated
after any spill of potentially dangerous material and at the end of the day’s work. All
contaminated materials, specimens and cultures must be decontaminated before disposal
or cleaning for reuse.

13.6.1.5 Design features: The laboratories should have the following design features:
• Ample space must be provided for the safe conduct of laboratory work and
for cleaning and maintenance.
• Walls, ceilings and floors should be smooth, easy to clean, impermeable to
liquids and resistant to the chemicals and disinfectants normally used in the
laboratory. Floors should be slip-resistant.
• Bench tops should be impervious to water and resistant to disinfectants,
acids, alkalis, organic solvents and moderate heat.
• Illumination should be adequate for all activities. Undesirable reflections
and glare should be avoided.
• Hand-washing basins, with running water if possible, should be provided
in each laboratory room, preferably near the exit door. Doors should have
vision panels, appropriate fire ratings, and preferably be self-closing.
• At biosafety level 2, an autoclave or other means of decontamination should
be available in appropriate proximity to the laboratory.

29
 GCLP Guidelines 2021

• Safety systems should cover fire, electrical emergencies, and emergency

shower facilities.
• In the planning of new facilities, consideration should be given to the
provision of mechanical ventilation systems that provide an inward flow
of air without recirculation. If there is no mechanical ventilation, windows
should be able to be opened.
• A dependable supply of good quality water is essential. There should be
no cross connections between sources of laboratory and drinking-water
supplies.
• There should be a reliable and adequate electricity supply and emergency
lighting to permit safe exit.
• Good maintenance of the installation is mandatory. Physical and fire security
must be considered. Other measures should be considered and applied, as
appropriate.

13.6.1.6 Equipment should be selected considering the following:

• Designed to prevent or limit contact between the operator and the infectious
material.
• Constructed of materials that are impermeable to liquids, resistant to
corrosion and meet structural requirements.
• Fabricated to be free of burrs, sharp edges and unguarded moving parts.
• Designed, constructed and installed to facilitate simple operation
and provide for ease of maintenance, cleaning, decontamination and
certification testing; glassware and other breakable materials should be
avoided, whenever possible.

13.6.1.7 Health and medical surveillance: The employing authority, through the
laboratory director, is responsible for ensuring that there is adequate surveillance of
the health of laboratory personnel. The objective of such surveillance is to monitor for
occupationally acquired diseases.

30
 GCLP Guidelines 2021

13.6.1.8 Guidelines for the surveillance of laboratory workers handling

microorganisms at Biosafety Level 1: Historical evidence indicates that the
microorganisms handled at this level are unlikely to cause human disease or
animal disease of veterinary importance. Ideally, however, all laboratory workers
should undergo a pre-employment health check at which their medical history is
recorded.

13.6.1.9 Guidelines for the surveillance of laboratory workers handling

microorganisms at Biosafety Level 2: A pre-employment health check is necessary.
The person’s medical history should be recorded and a targeted occupational health
assessment performed. Records of illness should be kept by the laboratory management.
Women of childbearing age should be made aware of the risk to an unborn child of
occupational exposure to certain microorganisms, e.g. Rubella virus. The precise steps
taken to protect the foetus will vary, depending on the microorganisms to which the
women may be exposed.

13.6.1.10 Waste handling: Waste is anything that is to be discarded. In laboratories,

decontamination of wastes and their ultimate disposal are closely interrelated. In terms
of daily use, few if any contaminated materials will require actual removal from the
laboratory or destruction. The overriding principle is that all infectious materials should
be decontaminated, autoclaved or incinerated within the laboratory.

13.6.1.11 Decontamination: Steam autoclaving is the preferred method for all

decontamination processes. Materials for decontamination and disposal should be
placed in containers, e.g. autoclavable plastic bags that are colour-coded according to
whether the contents are to be autoclaved and/or incinerated.

13.6.1.12 Handling and disposal procedures for contaminated materials and

wastes: Identification and separation system for infectious materials and their
containers should be adopted. National and international regulations must be
followed.

Categories should include: (a) Non-contaminated (non-infectious) waste that can be

reused or recycled or disposed of as general, “household” waste, (b) Contaminated

31
 GCLP Guidelines 2021

(infectious) “sharps” – hypodermic needles, scalpels, knives and broken glass should
always be collected in puncture-proof containers fitted with covers, decontaminated by
outoclaving and disposed.

13.6.2 The containment laboratory –Biosafety Level 3

13.6.2.1 Code of practice: The code of practice for basic laboratories – Biosafety
Levels 1 and 2 applies except where modified as follows-
• The international biohazard warning symbol and sign (Figure 1) displayed
on laboratory access doors must identify the biosafety level and the name
of the laboratory supervisor who controls access, and indicate any special
conditions for entry into the area, e.g. immunization.
• Open manipulations of all potentially infectious material must be conducted
within a biological safety cabinet or other primary containment device.
Respiratory protective equipment may be necessary for some laboratory
procedures or working with animals infected with certain pathogens.
Laboratory protective clothing must be of the type with solid-front or wrap-
around gowns, scrub suits, coveralls, head covering and, where appropriate,
shoe covers or dedicated shoes.

13.6.2.2 Laboratory design and facilities:

• The laboratory must be separated from the areas that are open to unrestricted
traffic flow within the building. Additional separation may be achieved
by placing the laboratory at the blind end of a corridor, or constructing a
partition and door or access through an anteroom (e.g. a double-door entry
or basic laboratory – Biosafety Level 2), describing a specific area designed
to maintain the pressure differential between the laboratory and its adjacent
space. The anteroom should have facilities for separating clean and dirty
clothing and preferably a shower.
• Anteroom doors may be self-closing and interlocking so that only one door
is open at a time. A break-through panel may be provided for emergency exit
use.

32
 GCLP Guidelines 2021

• Surfaces of walls, floors and ceilings should be water-resistant and easy to

clean. Openings through these surfaces (e.g. for service pipes) should be
sealed to facilitate decontamination of the room(s).
• The laboratory room must be sealable for decontamination. Air-ducting
systems must be constructed to permit gaseous decontamination.
• The building ventilation system should be constructed in a way that air
from the containment laboratory – Biosafety Level 3 is not recirculated to
other areas within the building. Air may be High-Efficiency Particulate Air
(HEPA) filtered, reconditioned and recirculated within that laboratory.
• An autoclave for the decontamination of contaminated waste material should
be available in the containment laboratory11.

13.6.2.3 Laboratory equipment: The principles for the selection of laboratory

equipment, including biological safety cabinets are the same as for the basic laboratory
– Biosafety Level 2. However, at Biosafety Level 3, manipulation of all potentially
infectious material should be conducted within a biological safety cabinet or other
primary containment device.

13.6.2.4 Health and medical surveillance: Same as Biosafety Levels 1 and 2

also apply to containment laboratories – Biosafety Level 3, except where, medical
examination of personnel is necessary and after a satisfactory clinical assessment,
the examinee may be provided with a medical contact card with photo and personal
details.

13.6.3 The maximum containment laboratory – Biosafety Level 4

The maximum containment laboratory – Biosafety Level 4 is designed for work

with Risk Group 4 microorganisms. Before such a laboratory is constructed and
put into operation, intensive consultations should be held with institutions that have
had experience of operating a similar facility. Operational maximum containment
laboratories – Biosafety Level 4 should be under the control of national or other
appropriate health authorities.

33
 GCLP Guidelines 2021

13.7 Biological safety cabinets (BSCs)

Biological safety cabinets are designed to protect the operator, the laboratory environment
and work materials from exposure to infectious aerosols and splashes that may be
generated when manipulating materials containing infectious agents, such as primary
cultures, stocks and diagnostic specimens (Annexure-6). Aerosol particles are created
by any activity that imparts energy into a liquid or semiliquid material, such as shaking,
pouring, stirring or dropping liquid onto a surface or into another liquid.

Other laboratory activities, such as streaking agar plates, inoculating cell culture
flasks with a pipette, using a multichannel pipette to dispense liquid suspensions of
infectious agents into microculture plates, homogenizing and vortexing infectious
materials, and centrifugation of infectious liquids, or working with animals, can generate
infectious aerosols.

Aerosol particles of less than 5 µm in diameter and small droplets of 5–100

µm in diameter are not visible to the naked eye. The laboratory worker is generally
not aware that such particles are being generated and may be inhaled or may cross
contaminate work surface materials. BSCs, when properly used, have been shown to be
highly effective in reducing laboratory-acquired infections and cross-contaminations of
cultures due to aerosol exposures. BSCs also protect the environment.

14.0 ETHICAL CONSIDERATIONS

Personnel working in clinical and/or research laboratories should be aware of their
ethical responsibilities and follow the basic and general ethical principles. The
researcher and the team are responsible for protecting the dignity, rights, safety
and well-being of the participants enrolled in the study, which are governed by the
following principles1:

• Principle of voluntariness whereby respect for the right of the subject/

participant to agree or not to agree to participate in research, or to withdraw
from research at any time, is paramount. The informed consent process
ensures that participants’ rights are safeguarded.
• Principle of non-exploitation whereby research participants are equitably
selected so that the benefits and burdens of the research are distributed fairly
34
 GCLP Guidelines 2021

and without arbitrariness or discrimination. Sufficient safeguards to protect

vulnerable groups should be ensured.
• Principle of social responsibility whereby the research is planned and
conducted so as to avoid creation or deepening of social and historic divisions
or in any way disturb social harmony in community relationships.
• Principle of ensuring privacy and confidentiality whereby to maintain
privacy of the potential participant, her/his identity and records are kept
confidential and access is limited to only those authorized. However, under
certain circumstances (suicidal ideation, homicidal tendency, HIV positive
status, when required by court of law etc.) privacy of the information can
be breached in consultation with the EC for valid scientific or legal reasons
as the right to life of an individual supersedes the right to privacy of the
research participant.
• Principle of risk minimization whereby due care is taken by all stakeholders
(including but not limited to researchers, ECs, sponsors, regulators) at all
stages of the research to ensure that the risks are minimized and appropriate
care and compensation is given if any harm occurs.
• Principle of professional competence whereby the research is planned,
conducted, evaluated and monitored throughout by persons who are
competent and have the appropriate and relevant qualification, experience
and/or training.
• Principle of maximization of benefit whereby due care is taken to design
and conduct the research in such a way as to directly or indirectly maximize
the benefits to the research participants and/or to the society.
• Principle of institutional arrangements whereby institutions where
the research is being conducted, have policies for appropriate research
governance and take the responsibility to facilitate research by providing
required infrastructure, manpower, funds and training opportunities.
• Principle of transparency and accountability whereby the research plan
and outcomes emanating from the research are brought into the public
domain through registries, reports and other scientific publications while
safeguarding the right to privacy of the participants. Stakeholders involved

35
 GCLP Guidelines 2021

in research should disclose any existing conflict of interest and manage it

appropriately. The research should be conducted in a fair, honest, impartial
and transparent manner to guarantee accountability. Related records, data
and notes should be retained for the required period for possible external
scrutiny/ audit.
• Principle of totality of responsibility whereby all stakeholders involved in
research are responsible for their actions. The professional, social and moral
responsibilities compliant with ethical guidelines and related regulations are
binding on all stakeholders directly or indirectly.
• Principle of environmental protection whereby researchers are accountable
for ensuring protection of the environment and resources at all stages of
the research, in compliance with existing guidelines and regulations.

15.0 QUALITY MANAGEMENT

Quality is the ability of a product or service to satisfy stated or implied needs of
a specific customer achieved by conforming to established requirements and
standards.

“Quality is doing the right things and doing those things right”.
A solid base for quality is to establish a strong foundation of Quality culture at all levels;
this will conveniently lead to achieving all goals.

The watchwords are “SAY WHAT YOU DO, DO WHAT YOU SAY & PROVE IT”.
Quality Hierarchy
• Quality Control
• Quality Assurance
• Quality Management

Quality Control (QC): Defined as “part of quality management focused on fulfilling

quality requirements.” Quality control is more the inspection aspect of quality
management. An alternate definition is “the operational techniques and activities used
to fulfil requirements for quality.”

36
 GCLP Guidelines 2021

Quality Assurance (QA): Quality assurance can be defined as “part of quality

management focused on providing confidence that quality requirements will be
fulfilled.” The confidence provided by quality assurance is twofold – internally to
management and externally to customers, government agencies, regulators, certifiers,
and third parties.

An alternate definition is “all the planned and systematic activities implemented within
the quality system that can be demonstrated to provide confidence that a product or
service will fulfil requirements for quality.

Quality Management System (QMS): Incorporates the organizational structure,

resources, responsibilities, document hierarchy, interaction of processes and
procedures needed to implement quality management of the laboratory. The
quality management system describes the integration of all processes required to
fulfill its quality policy and objectives and meet the needs and requirements of
the users.

Whereas, QC refers to the process of minimizing examination errors, QA encompasses

procedures adopted for minimizing errors that may occur at any stage.

16.0 INTERNAL QUALITY CONTROL

The first essential in setting up internal quality control (IQC) of a test procedure in
the laboratory is to select the proper IQC procedure to implement, i.e. choosing the
statistical criteria or control rules, and the number of control measurements, according
to the quality required for the test and the observed performance of the method4. Practice
of IQC includes-

• Recognition of errors which arise within the laboratory during examination

stage (testing)-
- Taking steps to minimize errors.
- Equipment calibration and method verification / validation.

• Quality control checks for both quantitative and qualitative tests.

37
 GCLP Guidelines 2021

16.1 IQC for Quantitative Tests

• Levy Jennings’s (LJ) chart is the most common graphical tool to plot daily
QC values. Most of the current analyzers have inbuilt software to do this
automatically, if this is not available, it can be done manually using excel
sheet. Laboratories can also opt for commercially available IQC tools, LIS
modules, middleware modules, etc.

From these charts trends and shifts in IQC of a test can be easily identified.

Calculate/Obtain lab’s mean and SD, CV% from the IQC data (periodically/
monthly). Only valid data should be considered for establishing mean/SD.
Irrespective of the size, all labs shall analyze two levels IQC once daily.
• 24 x 7 operating labs shall run:
i) Two levels of QCs once in the peak hour daily
ii) One level every 8 hrs. (Total 3 times in a day)
When one level QC is used-
Reject test run if following errors occur:
- Value is outside 3 SD (13S)
- 2 consecutive values are outside 2 SD on the same side, but within
3 SD (22S)
- 10 consecutive values or above or below the mean, but within 2 SD (10x)
When two level QC are used:
Reject test run if following errors occur:
- Either QC value is outside 3 SD (13S)
- Both QC values are outside 2 SD on the same side, but within 3SD (22S)
- Difference between the two level QC values is >4 SD i.e. one level
QC is
>2 SD and other level QC is < 2 SD (R4S)
- 10 consecutive values of the same level QC are above or below the
mean, but within 2 SD (10x)
- 5 consecutive values of one level QC and 5 consecutive values of the other
level QC are above or below the mean, but within 2 SD (10x)

38
 GCLP Guidelines 2021

Note 1: The laboratory personnel performing the test should determine the appropriate
corrective action to be taken for QC data that fall outside the established tolerance
limits. Corrective action should be documented with the technician’s initials
and date.
Note 2: Tests for which control material is not available or when running of control
is not viable due to low volume of tests, the laboratory should apply alternate quality
control techniques such as-
- Retesting of any randomly chosen specimen/s
- Replicate test of specimen by different method, different machine and
different person, wherever applicable
- Correlation of test results with other parameters
The laboratory should review trend of Measurement Uncertainty or CV% to identify
any significant trends and shifts and maintain the records of review. 

16.2 IQC for Qualitative Tests

For qualitative tests, positive and negative controls should be included with each run.
For staining procedures, gram stains require both Gram positive and Gram negative
control organisms to be used once per week. QC should also be run whenever a new
lot of the stain procedure kit is used and/or any of the four components of the stain
procedure kit is replaced with a new lot.

16.3 Reagent lot Verification- Uniformity of results is of paramount importance.

Each change in reagent lots can adversely affect the consistency and quality of patient
results. Assuring lot-to-lot uniformity is particularly important for those analytes that
are serially measured over time such as CBC, HbA1c, TSH, tumor markers and liver
enzymes, etc.
Performance of a new lot of reagents should be compared against the existing lot before
the existing lot is finished. Other alternatives to patient samples preferred for checking
lot to lot variability may be4-
1. Reference materials or QC products provided by the method manufacturer
with method-specific and reagent-lot-specific target values.
2. Proficiency testing materials with peer-group established means.

39
 GCLP Guidelines 2021

17.0 EXTERNAL QUALITY ASSESSMENT/ PROFICIENCY

TESTING (EQA/PT)
EQA/PT is the evaluation of participant performance against pre-established criteria
by means of inter laboratory comparisons. Participation in EQA/PT program is the
best measure of accuracy of a test for clinical laboratories. Hence, clinical laboratories
should enroll for all tests in this program, as far as feasible.

Benefits of EQA/PT participation:

- Assesses the overall performance of laboratory for each test
- Serves as an early warning system for problems
- Identifies systematic problems
- Provides objective evidence of laboratory quality
- Identifies training needs

The EQA/PT schemes usually have the following salient steps-

1. The laboratory enrolls in a EQA/PT scheme/s
2. The EQA/PT provider sends EQA/PT items to participating laboratories at
defined interval.
3. The participating labs analyze the samples and return their results to the
EQA/PT provider within the timeline, usually through a web portal.
4. The results are evaluated by the EQA/PT provider and the laboratories are
provided with statistical data and performance score (e.g.: z score, SDI,
etc.). The laboratory can review its own performance and also compare with
other participants/peers.
5. The laboratories must take appropriate corrective and preventive actions
when the score deviates from the acceptable limits.
6. The participating laboratories are expected to use the information regarding
their performance to make appropriate changes and improvements in their
operational processes, as and when needed.

40
 GCLP Guidelines 2021

Rightly used and understood EQA/PT participation will stimulate technical competence
of a laboratory.

If EQA/PT program for a particular analyte is not available, an appropriate

inter-laboratory comparison or any other alternate method (retesting of retained
item, testing by different personnel, use of certified reference materials etc.) is
recommended.

EQA/PT providers who run these programs get accreditation13 under ISO/IEC 17043:2010.
Laboratories should enroll in an accredited EQA/PT program4, if available.

18.0 INTERNAL AUDIT

Audit is a process of critical review of the functioning and evaluation of services.
Internal audit is a process of comprehensive review of the functioning and evaluation
of services. Internal audit is the systematic, independent and documented process for
obtaining audit evidence and evaluating it objectively to determine the extent to which
the specific criteria are complied with. Internal audit can be effectively carried out by
examining documents, specimens, equipment, procedures, environmental conditions,
examination procedures, personnel competence, records and reports. Effective internal
audit will identify the problems and weak points in the system and suggest remedial
measures. Laboratory shall conduct one complete cycle of internal audit at least once
in twelve months.

Internal audit should be done by a person who has been trained as an auditor. It is
recommended that all internal auditors undergo 4-day Standard and Internal auditor
training3.

19.0 TECHNICAL AUDIT CHECKLIST

A technical audit checklist (Annexure-7) needs to be maintained by each laboratory. A
model technical audit checklist is provided in Annexure-7, which needs to be maintained
by each laboratory. Laboratories may adapt this to make it more comprehensive and
relevant.

41
 GCLP Guidelines 2021

20.0 RISK MANAGEMENT

Risk is a combination of the probability of occurrence of harm and the severity of that
harm14 (ISO/ISE Guide 51)
- Hazard: Potential source of harm
- Harm: Physical injury or damage to the health of people
- Severity: Measure of the possible consequences of a hazard15

RISK MANAGEMENT: “The laboratory shall evaluate the impact of work

processes and potential failures on examination results as they affect patient safety,
and shall modify processes to reduce or eliminate the identified risks and document
decisions and actions taken3”.

Risk management Process: Laboratories should create a process map that outlines all
the steps of the testing process from physician order to reporting the result (wherever
applicable) (Figure-2).

21.0 QUALITY INDICATORS

• It is essential for the laboratory to establish quality indicators towards
monitoring and evaluating performance throughout critical aspects of
pre-examination, examination and post-examination processes.

• Purpose of Quality Indicators

• Give information about the performance
• Determine the quality of services
• Highlight potential quality concerns
• Identify areas that need further study & investigation
• Track changes over time

Characteristics of good Quality Indicators

• Measurable
• Achievable

42
 GCLP Guidelines 2021

• Actionable
• Balanced
• Timed

Examples of Quality Indicators

Pre-examination-
• Specimen Container labeling Error
• Specimens rejected
• Specimens without mandatory history
• Specimens received beyond stability period
• Specimen quantity inadequate
• Specimen label and TRF details not matching

Examination-
• IQC – Improvement in % CV of analytes over 12 month period
• PT – Improvement in PT performance (e.g. x score, SDI, etc.)
• Equipment downtime
• Kit non-availability
• Trainings conducted

Post Examination-
• Inpatient laboratory result availability (% of test results available for
morning rounds as stipulated in the institution policy)
• Critical values reporting in defined time
• Turnaround time (achieved/defined)
• Clinician or customer satisfaction with laboratory services
• Complaints (number, critical, time to resolve, etc.)

Laboratory can define indicators beyond these also e.g. number of spills, cost per
reportable test, productivity per technician, etc.

43
 GCLP Guidelines 2021

22.0 DATA MANAGEMENT

22.1 Data integrity: Data integrity is defined as paper-based or electronic data that is
complete, accurate, consistent, and reliable through its lifecycle from the time of data
creation, archival, scanning, retention upto destruction. Few countries have defined it as
ALCOA acronym with respect to data integrity:
ALCOA:
A-Attributable
L-Legible
C-Contemporaneous
O-Original
A-Accurate

Data integrity can be monitored by keeping a check on the following areas:

• Source Data Verification (SDV) through good documentation practices
• Data access and control
• Training of personnel involved in data collection
• Data monitoring: on-site, centralized, and risk-based monitoring
• Quality assurance

22.2 Confidentiality
• Confidentiality of data should be maintained including interim data results
throughout the process.
• The ability to tamper with data such as changing, deleting or falsifying data
should be restricted by clearly demarcating roles.
• This also prevents potential conflict of interest that may hamper data
integrity.

22.2.1 Data integrity Audits

• Specific audits look out for any data or metadata that previously went
unnoticed such as deleted or unchecked, misused, orphaned, or reprocessed
data.
• The entire data lifecycle should be subjected to scrutiny by all departments
involved in the trial such as, but not limited to, data management, safety,

44
 GCLP Guidelines 2021

quality risk management, and statisticians for compliance issues in areas of

data management and data access control.

22.3 Data Security: It can be divided in to four components

22.3.1. Hardware Security
a. Operating systems should be up to-date operating systems
b. Malware Protection: All laboratory computers should have robust
anti-virus software installed and configured for automated, regular
virus definition updates and file scanning.
c. Interfaced instruments: Laboratory instruments are exposed to similar
security issues as laboratory computers. The instrument’s operating
system, hardware protection and Malware protection must be
addressed.
d. Mobile devices: There should be steps in place to develop secure
authentication for mobile devices (e.g., smartphones, tablets, etc.)
along with the ability to track and secure mobile devices remotely by
locking or wiping out information.

22.3.2 Network Security

a. On-premise hosting data security. This hosting option allows strong
data security with data protected by the company firewall, although
using cloud-based services.
b. External and cloud-based hosting data security. There are availability
of licensed fully external cloud-based “Software-as-a-service”
offerings.
c. For internet transmission of patient data, the minimum security
requirements by utility Secure Socket Layer (SSL) protocols, which
encrypt data using a private key, to protect patient confidentiality.

22.3.3 Application Security

a. Passwords: All applications should be passwords enabled as the
main method of user authentication. Organizations should formulate

45
 GCLP Guidelines 2021

procedures for creating, changing and safeguarding passwords that

allow access to systems with critical data.
b. Two-factor authentication: Applications utilized by laboratories
should ideally have Two Factor authentication capabilities.
c. Role-based access control: Laboratory information systems should
also have the ability to control which users can use the system, what
information they have access to, and what they can do with the data
(e.g., read only, or the ability to change or delete data).

22.3.4 Personnel Security

a. Employee training and compliance: Security awareness training
should be provided for all employees at the time of their hire, and
this initial training should be reinforced periodically with follow-up
security reminders.
b. Peripheral devices: Any IT hardware, namely computer terminals,
should be viewed as a potential site for rouge employees to extract
data via peripheral storage devices (e.g., USB thumb drives, eSATA
disk drives).
Role of Laboratory data management starts with the creation of a new UID/ patient
sample and includes recording details of the patient, findings or analysis, reporting of
results and archiving the data for future reference and ensuring confidentiality at all
stages, as required and applicable.
Laboratory data management is a highly specialised field. A laboratory may choose to
manage data manually in the form of reports or through online system, but either way it
is the responsibility of the laboratory to manage and store data as per their policy. But
in both the cases, laboratory should have a documented procedure to ensure that the
confidentiality of patient information is maintained at all times.
Disaster Recovery Plan: Laboratory should have a functional plan to manage data
and ensure continuity of services in case of natural disasters like floods, earthquakes,
extensive fire, etc.
22.4 Laboratory Record- All the released laboratory reports should be stored as per
the national/ regulatory requirements.

46
 GCLP Guidelines 2021

22.4.1 The records can be maintained as physical copies (instrument printouts or as

photocopies) or electronically (LIS/HIS).
• In hospital attached laboratories, Hospital Information System (HIS) manages all
the activities of a hospital including laboratory, which is an integrated information
system. Independent Laboratories are managed by Laboratory Information systems
(LIS) which are designed to process and report data related to individual patients
in a clinical setting. Wheareas, Laboratory Information Management Systems
(LIMS) are designed to process and report data related to batches of samples from
drug trials and other entities.
• Use of LIS/LIMS enables a laboratory to track specimens from receipt, processing,
testing and reporting to storage. It captures patient/research data electronically
and integrated patient and specimen information and thus enable determination of
patient outcomes and support patient management.

Procedure for adequate data protection and security including data editing and deleting
should be developed and maintained by the laboratory.

47
 GCLP Guidelines 2021

REFERENCES:
1. National Ethical Guidelines for Biomedical and Health Research involving
Human Participants. Indian Council of Medical Research 2017.
2. New Drugs and Clinical Trials Rule, Published by Ministry of Health and
Family Welfare (Department of Health and Family welfare), Notification
New Delhi, the 19th March, 2019.
3. International Organization for Standardization (ISO) 15189:2012 “Medical
laboratories –Requirements for quality and competence”.
4. National Accreditation Board for Testing and Calibration Laboratories
(NABL), 112- “Specific Criteria for Accreditation of Medical Laboratories”,
Amended 26-Apr-2019.
5. Indian Public Health Standards (IPHS) Guidelines for Primary Health
Centres Revised 2012.
6. Indian Public Health Standards (IPHS) Guidelines for Community Health
Centres Revised 2012.
7. Indian Public Health Standards (IPHS) Guidelines for District Hospital
Revised 2012.
8. National Essential Diagnostics List (NEDL), Indian Council of Medical
Research (ICMR), 2019.
9. Laboratory Quality Management System: handbook, WHO, 2011.
10. Indian Standard (IS)- Reagent Grade Water- Specification (Third revision),
1070: 1992.
11. Bio-Medical Waste Management Rules, 2016. [Published in the Gazette
of India, Extraordinary, Part II, Section 3, Sub-section (i)] Government of
India Ministry of Environment, Forest and Climate Change.
12. Laboratory Biosafety Manual, WHO, 3rd Edition, 2004.
13. International Organization for Standardization (ISO/IEC) 17043:2010,
“Conformity assessment. General requirements for proficiency testing”.
14. ISO/IEC Guide 51:2014, Safety aspects- Guidelines for their inclusion in
standards
15. International Organization for Standardization (ISO) 14971:2007 “Medical
devices – Application of risk management to medical devices”, Corrected
version 2007-10-01.
16. Laboratory Quality Control Based on Risk Management, 1st Edition.

48
 GCLP Guidelines 2021

Additional Reading:
1. GCLP: 12 best practices for Clinical Trials by Dr David Hutchinson &
Sharon Jordan, Nov., 2016-Book.
2. Good Clinical Practice for Clinical Research in India. New Delhi (IN):
Central Drugs Standard Control Organization, Ministry of Health and
Family Welfare, Government of India; 2001.
3. Organization for Economic Co-operation and Development (OECD), OECD
Principles of Good Laboratory Practice (as revised in 1997), 1998.
4. Division of AIDS (DAIDS) Guidelines for Good Clinical Laboratory
Practice Standards, National Institute of Allegry and Infectious Diseases,
final version 3.0, dated 9th July 2013.

49
 GCLP Guidelines 2021

Annexure-1: Equipment Log Book (Scheduled Maintenance)

Name & Model of Equipment……………....…...…… Emergency Tel No……..……..
Date of Installation……….....................................….. Warranty Period……………….
Date of Validation…......….. Date of Company Calibration…......….. Next due on..…..
Company Company Problems Rectification Parts repaired, Remark,
maintenance maintenance observed details with replaced with Signature name,
schedule date as done with with date date & time date & time designation
per AMC/ CMC date & time & time

50
 GCLP Guidelines 2021

Annexure-2: Equipment Log Book (Emergency/Breakdown)

Name & Model of Equipment……………..………… Emergency Telp No…………..
Date of Installation………....................................….. Warranty Period……........…….
Date of Validation……….. Date of Company Calibration……..…. Next due on ……
Problem Service Carried out Spare part Remark, Signature
Encountered with date & time replaced (if any) Name, Designation

51
 GCLP Guidelines 2021

Annexure-3: Requisition Form

Name ……………….................................……... Age ….…….. Sex ……………….

UID No. (if any)/ OPD No …………...............................……………………………

Consultant In- Charge ……………….......................................………………………

Date and Time of specimen collection ….....…………………………………………

Type of Specimen ……………………………..………………………………………

Tests requested …………………………………..……………………………………

……………………………………………………...…………………………………

Provisional diagnosis (if applicable) …………………………………………………

………………………………………………………...........…………………………

Relevant Clinical History including drug treatment (if any) …………………………

…………………………………………………………...……………………………

…………………………………………………...……………………………………

………………………………………………...………………………………………

…………………………………………...…………………………………………....

…………………………………………………………………………………….......

…………………………………………………………………………………….......

Signature:

Name, Designation:

Date:

52
 GCLP Guidelines 2021

Annexure-4: Specimen Rejection Record

S.No. UID No. Type of Reason for Remarks Signature
Specimen Rejection with
Name &
Designation
and Date

53
 GCLP Guidelines 2021

Annexure-5: Reporting Format

Lab Name/No. (if any) …………............................................................…………….

Name………………………………………....……………………………………….

Age……..........…… Sex…………………

UID/OPD No. …………...……………… Referred by: ……………..………………

Date of specimen collection …………….....................………………………………

Date & time of specimen receipt ……….........................................………………….

Date & time of Report ……………..…………………………………………………

Test Name ………….............................…………….

Method used……………………..……………………………………………………

Test Result ……………………………………………………………………………

………………………………………...………………………………………………

Reference Interval……………………………………………………………………..

………………………………………...………………………………………………

Interpretation ………………………………………………………………………….

………………………...………………………………………………………………

……………………………...…………………………………………………………

………………………………...………………………………………………………

Date of reporting……………………………………………………….

Authorized Signatory……………………………………………….

54
 GCLP Guidelines 2021

Annexure-6
Differences between Class I, II and III biological safety cabinets (BSCs)

BSC FACE Airflow (%) Exhaust

VELOCITY System
(M/S) Recirculated Exhausted

Class IA 0.36 0 100 Hard Duct

Class IIA1 0.38–.51 70 30 Exhaust to

Room or
Thimble
Connection

Class IIA2 Vented 0.51 70 30 Exhaust to

to The Outsidea Room or
Thimble
Connection

Class IIB1A 0.51 30 70 Hard Duct

Class IIB2A 0.51 0 100 Hard Duct

Class IiiA NA 0 100 Hard Duct

NA, not applicable.

a
All biologically contaminated ducts are under negative pressure or are surrounded by
negative pressure ducts and plenums.
Source: Laboratory Biosafety Manual, WHO, 3rd Edition, 2004

55
 GCLP Guidelines 2021

Annexure-7
TECHNICAL AUDIT CHECKLIST-
 SOPs
 IQC Data – Precision statistics
 LJ Charts
 EQA data / Proficiency Testing
 Corrective actions taken QC/EQA outliers
 Sample handling, identification & storage
 Measurement traceability
 Equipment maintenance & Calibration
 Data on uncertainty of measurements

56
 GCLP Guidelines 2021

Figure-1
Biohazard Sign12

Adapted from Laboratory Bio-safety Manual, WHO, 2004

12

57
 GCLP Guidelines 2021

Figure-2
16
RISK MANAGEMENT PROCESS

16
 dapted from CLSI EP-23A, 2011, Vol-31, no.-18, Lab Quality control based on
A
risk management

58
 GCLP Guidelines 2021

Drafting/ Advisory Committee Members (in Alphabetical Order)

Dr. A S Kanagasabapathy Chairman
Former Prof. & Head, Deptt. of Clinical Biochemistry
Christian Medical College
Vellore

Dr. Arti Kapil 

Professor
Department of Microbiology
All India Institute of Medical Sciences, New Delhi India

Dr. Bhupendra Kumar Rana

Founding CEO
Quality and Accreditation Institute (QAI)
Sector 18, Noida

Dr. Bikash Medhi Vice-Chairman

Professor, Deptt. of Pharmacology
Post Graduate Institute of Medical Education and Research
Chandigarh

Dr. Heena Tabassum

Scientist ‘C’
Division of Basic Medical Sciences
Indian Council of Medical Research
New Delhi

Dr. Monika Pahuja

Scientist ‘C’
Division of Basic Medical Sciences
Indian Council of Medical Research
New Delhi

59
 GCLP Guidelines 2021

Dr. Purva Mathur

Professor, Laboratory Medicine (Trauma Centre)
All India Institute of Medical Sciences,
New Delhi

Dr. R Lakshmy
Professor, Cardiac Biochemistry (Cardio-Thoracic Sciences Centre),
All India Institute of Medical Sciences,
New Delhi

Dr. Shalini Singh

Scientist ‘G’ and Director
ICMR- National Institute of Cancer Prevention & Research 
Noida

Dr. Usha Aggarwal

Scientist ‘F’
ICMR-National Institute of Pathology
New Delhi

Dr. Vijay Kumar

Former Scientist ‘G’ and Head
Division of Basic Medical Sciences
ICMR, New Delhi

60
 GCLP Guidelines 2021

Reviewer
Dr. Puneet K. Nigam
Senior Vice-President,
Quality and L&D
Metropolis Healthcare India

ICMR Secretariat
Dr. Vijay Kumar
Former Scientist ‘G’ and Head
Division of Basic Medical Sciences
ICMR, New Delhi

Dr. Monika Pahuja

Scientist ‘C’
Division of Basic Medical Sciences
Indian Council of Medical research
New Delhi-110029

Dr. Heena Tabassum

Scientist ‘C’
Division of Basic Medical Sciences
Indian Council of Medical research
New Delhi-110029

61