Good Laboratory Practices

Dhavalkumar Surti
 Origin of Good Laboratory Practices
• In the 1970s, FDA inspections of nonclinical laboratories revealed
that some studies submitted in support of the safety of regulated
products had not been conducted in accord with acceptable
practice, and that accordingly data from such studies was not always
of the quality and integrity to assure product safety.
• Results of this investigation in about 40 laboratories revealed many
cases of poorly managed studies, insufficient training of personnel,
and some cases of deliberate fraud

As a result of these findings, FDA promulgated the Good Laboratory Practice (GLP) Regulations, 21
CFR Part 58, on December 22, 1978 (43 FR 59986). The regulations became effective June 1979.

The regulations establish standards for the conduct and reporting of nonclinical laboratory studies
and are intended to assure the quality and integrity of safety data submitted to FDA.

FDA relies on documented adherence to GLP requirements by nonclinical laboratories in judging

the acceptability of safety data submitted in support of research and/or marketing permits.
 Objective of Good Laboratory Practices Guideline
by FDA (21 CFR Part 58)
FDA’s CFR- Code of Federal Regulations Title
21, Part 58 is for ‘Good Laboratory Practices
for Nonclinical Laboratory Studies’
1. To verify the quality and integrity of data
submitted in a research or marketing
application.
2. To inspect (approximately every two
years) nonclinical laboratories conducting
safety studies that are intended to support
applications for research or marketing of
regulated products.
3. To audit safety studies and determine the
degree of compliance with GLP regulations.
Quality Control
Laboratory (Chemistry)
Quality Control Laboratory (Chemistry)
• Sample Receipt and Storage Area
• Chemicals storage area
• Wet Lab
• Dry Lab
• Raw Material and Primary Packing Material
Testing
• In-Process Sample Testing
• Semi Finished Product Testing
• Finished Product Testing
• Hazardous Chemical Storage
• Special Hoods for Test involving Hazardous
Chemical
Microbiology LaboratorY
 Microbiology Laboratory
• Sample receipt and storage area
• Media storage area
• Sterility testing Laboratory
• BET Testing Laboratory
• Incubator area
• Component autoclave for sterilization of sterility testing
components
• Media sterilization autoclave
 Objective of Good Laboratory Practices Guideline
by FDA
Good Laboratory Practices stress the
importance of the following five points:
1. Resources: organization, personnel,
facilities and equipment
2. Characterization: test items and test
systems
3. Rules: study plans (or protocols) and
written procedures
4. Results: raw data, final report and
archives
5. Quality assurance.
 Good Laboratory Practices Guideline ensures that activities are…
• Planned
• Performed
• Recorded
• Reported
• Archived
• Monitored

• Good laboratory practice is required to avoid

mistakes and make sure everyone is
following the same rules.
• This leads to the production of accurate and
quality data that can be used in the
development of drugs to prevent and fight
human disease.
Good Laboratory Practices
Standard Operating Procedures
• SOPs are the guidelines that inspectors and
laboratories should follow. The procedures
should be clearly written and easily accessible to
all staff.

• In addition to the guidelines, a set of forms or

documents should be available to record data.
These should be consistent, easy to understand,
and complete.

• The SOPs ensure standards are measured and

being met. This establishes the efficient
production and reliable research results.
Good Laboratory Practices
Data Recording
• Data recording includes what the test was, how it was
performed, when it was carried out, and who did it.

• All data must be recorded correctly when it is produced

to avoid errors.

• Staff should never rely on memory as the wrong data

could be recorded and have serious consequences. This
practice ensures traceability and correct record-
keeping, whether paper-based or electronically.

• Standard laboratory notebooks should be used, and

data should be entered into computers in the correct
format.

• Data should be clear and concise and readable for

other staff. The laboratory’s generic terms should be
used for clarity.
Good Laboratory Practices
Correct Use of Equipment

• Use of the wrong or uncalibrated

equipment could present inaccurate data.

• The equipment type and recalibration

should be carried out before any test takes
place.

• The specified instruments and equipment

should be well-maintained according to a
specified program and only used as
intended. This helps deliver reliable data
and prevents data loss. Records of
equipment maintenance should be kept.
 Good Laboratory Practices
Staff
• Only staff qualified to carry out particular testing
procedures should do so.

• Staff should understand their role and have a job

description. Records of staff qualifications and
training and development should be kept.

• A pharmaceutical research study is usually overseen

by a study director, who is responsible for the results
of the study. It is their role to check correct practice
is followed and to sign off the results at the end of
the study.
 Good Laboratory Practices
Test Items
• Test material should be
labeled and stored at all
times at the correct
conditions including
temperature, light/darkness,
and humidity.

• The sample should carry the

date, study details, batch
number and any other
required information set out
in the procedures.
Good Laboratory Practices
Correct Training
• Training is an essential part of good
laboratory practice examples. Staff
involved in laboratory work must
understand the practices to be
followed and why they are important.

• This applies to the training of new staff

and refresher training for existing staff
to remind them of testing, analysis,
and reporting practices as well as
introducing new ones.
Good Laboratory Practices
Environment
• All testing should be carried out in a
laboratory designated for the purpose.

• The atmosphere should be at the correct

temperature, there should be enough
space to work, sites should be clean before
and after the test and cross-contamination
protocols should be observed.

• Staff should wear correct laboratory

clothing and relevant PPE (personal
protective equipment) at all times.
Good Laboratory Practice: Regulatory Requirements
Quality Assurance Unit
• A testing facility shall have a quality assurance unit
which shall be responsible for monitoring each study
to assure management that the facilities, equipment,
personnel, methods, practices, records, and controls
are in conformance with the regulations in this part.

• For any given study, the quality assurance unit shall be

entirely separate from and independent of the
personnel engaged in the direction and conduct of that
study

• Quality assurance unit maintains master schedule list

of all studies, copies of all protocols
 Good Laboratory Set Up-
Proper planning of
studies and allocation Provision of adequate Definition of staff responsibilities and
facilities, infrastructure and provision of staff training.
of resources. qualified staff.
Lack of coordination  Inadequate analyst qualification
Not having adequate
between production  Switching responsibilities
number of instruments
and laboratory
Not utilizing  Multi-tasking
Improper resource
available instruments
allocation (not
effectively (no working
according to priority)
in second/third shift) Good record keeping and
Non knowing Priority
organized archives.
Establishment of procedures to ensure proper Recording on non-
conduct of studies. GMP records
Test procedures are not adequately
elaborated
Implementation of
Test procedures are not updated
verification procedures for
Pharmacopeia updates are not included
study conduct and results.
in test procedures
 Some of FDA Investigations Observations
• Poorly-trained Study Directors and study personnel
• Poorly-designed protocols
• Protocols not followed - procedures not conducted as
prescribed
• Raw data badly collected - not correctly identified - without
traceability - not verified or approved by responsible persons
• Lack of standardized procedures
• Poor animal husbandry
• Inadequate characterisation of test items and test systems
• Inadequate resources
• Equipment not properly calibrated or otherwise qualified
• Reports not sufficiently verified, inaccurate account of study
or raw data
• Inadequate archives and retrieval processes
Good Laboratory Practice: Regulatory Requirements
• Analyst Certification
• All analysts working in the QC lab should be educated and qualified analysts.
• They should be certified for the analysis as per the analyst qualification procedure.
• Test is invalid if unqualified analyst has carried it out.

• Laboratory Facility Certification

• The QC lab will be independent of the manufacturing area.
• Separate area will be provided for physico-chemical and microbiological analysis.
• QC lab will be designed appropriately to carry out the operations.
• Sufficient space will be provided for storage of test sample, reference samples, reference standard, reagents, media
and records.

• Sample/Material Tracking
• Any sample or material entering the QC lab will be entered in the respective inward register and then will be stored
at the specified location.
• Sufficient reference and control samples of the product and the starting materials are retained to permit future
examination.
• There will be a system for avoiding the mix up of the samples or materials.
• There will be a proper tracking record for each and every material, sample, and instrument and testing.
Good Laboratory Practices
Good Laboratory Practices
Good Laboratory Practices
Good Laboratory Practices
Good Laboratory Practices
Good Laboratory Practices
Good Laboratory Practices
Good Laboratory Practices
Good Laboratory Practices
Audit and Inspections
These must be performed routinely to check
that procedures are being followed. Both
internal and external audits are necessary to
verify if the good practice system is working
correctly and if it needs any modifications.

Audits primarily cover research protocol,

processes, and reporting. Inspections take
place by external regulatory bodies such as the
EMA (European Medicines Agency) and the
FDA (US Food and Drug Administration).
Good Laboratory Practice: Regulatory Requirements
• Personnel Working in Laboratory
Each individual engaged in the Personnel shall take necessary
conduct of or responsible for personal sanitation and health
the supervision of a precautions designed to avoid
nonclinical laboratory study contamination of test and
shall have education, training, control articles and test
and experience, or systems
combination thereof, to
enable that individual to
perform the assigned
functions. Each testing facility shall
maintain a current summary
of training and experience and
There shall be a sufficient job description for each
number of personnel for the individual engaged in or
timely and proper conduct of supervising the conduct of a
the study according to the nonclinical laboratory study.
protocol.
Good Laboratory Practice: Regulatory Requirements
•Facilities
• Each testing facility shall be of suitable size and construction to facilitate the proper conduct of
nonclinical laboratory studies. It shall be designed so that there is a degree of separation that will
prevent any function or activity from having an adverse effect on the study.
• As necessary to prevent contamination or mixups, there shall be separate areas for:
• Receipt and storage of the test and control articles.
• Mixing of the test and control articles with a carrier, e.g., feed.
• Storage of the test and control article mixtures.
• Storage areas for the test and/or control article and test and control mixtures shall be separate from
areas housing the test systems and shall be adequate to preserve the identity, strength, purity, and
stability of the articles and mixtures.
• Separate laboratory space shall be provided, as needed, for the performance of the routine and
specialized procedures required by nonclinical laboratory studies.
 Good Laboratory Practice: Regulatory Requirements

•Equipment Equipment shall be adequately

Equipment used in the inspected, cleaned, and maintained.
generation, measurement, or Equipment used for the generation,
assessment of data and measurement, or assessment of data
equipment used for facility shall be adequately tested, calibrated
environmental control shall and/or standardized.
be of appropriate design and
adequate capacity to function The written standard operating
according to the protocol and procedures shall designate the
shall be suitably located for person responsible for the
operation, inspection, performance of each
Written records shall be maintained of all inspection,
cleaning, and maintenance. operation. maintenance, testing, calibrating and/or standardizing
operations. These records, containing the date of the operation,
The written standard operating procedures required shall set shall describe whether the maintenance operations were routine
forth in sufficient detail the methods, materials, and schedules and followed the written standard operating procedures. Written
to be used in the routine inspection, cleaning, maintenance, records shall be kept of nonroutine repairs performed on
equipment as a result of failure and malfunction. Such records
testing, calibration, and/or standardization of equipment, and
shall document the nature of the defect, how and when the
shall specify, when appropriate, remedial action to be taken in defect was discovered, and any remedial action taken in response
the event of failure or malfunction of equipment. to the defect.
Good Laboratory Practice: Regulatory Requirements
• Testing Facilities Operation
Standard operating procedures: Standard operating procedures
A testing facility shall have shall be established for, but not
standard operating procedures in limited to, the following:
writing setting forth nonclinical • Receipt, identification,
laboratory study methods that storage, handling, mixing, and
management is satisfied are method of sampling of the
adequate to insure the quality and test and control articles.
integrity of the data generated in • Data handling, storage, and
the course of a study. All retrieval.
deviations in a study from • Maintenance and calibration
standard operating procedures of equipment.
shall be authorized by the study
director and shall be documented Each laboratory area shall have
A historical file of standard
in the raw data. Significant immediately available laboratory manuals
operating procedures, and all
changes in established standard and standard operating procedures relative
revisions thereof, including the
operating procedures shall be to the laboratory procedures being
dates of such revisions, shall
properly authorized in writing by performed. Published literature may be
be maintained.
management. used as a supplement to standard operating
procedures.
Good Laboratory Practice: Regulatory Requirements
• Testing Facility Management
Study director means the individual responsible for the overall conduct
of a nonclinical laboratory study.
For each nonclinical laboratory study, a scientist or other professional of
appropriate education, training, and experience, or combination thereof,
shall be identified as the study director. The study director has overall
responsibility for the technical conduct of the study, as well as for the
interpretation, analysis, documentation and reporting of results, and
represents the single point of study control.

Testing facility management shall

• Designate a study director, before the study is initiated.
• Replace the study director promptly if it becomes necessary to do so during the conduct of a study.
• Assure that there is a quality assurance unit.
• Assure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability,
and uniformity, as applicable.
• Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled.
Good Laboratory Practice: Regulatory Requirements
• Testing Facility Management
The study director shall assure that:
(a) The protocol, including any change, is approved and is
followed.
(b) All experimental data, including observations of
unanticipated responses of the test system are accurately
recorded and verified.
(c) Unforeseen circumstances that may affect the quality
and integrity of the nonclinical laboratory study are noted
when they occur, and corrective action is taken and
documented.
(d) Test systems are as specified in the protocol.
(e) All applicable good laboratory practice regulations are
followed.
(f) All raw data, documentation, protocols, specimens, and
final reports are transferred to the archives during or at the
close of the study.
Good Laboratory Practice: Regulatory Requirements
• Testing and Data Record
• All the testing and data recording will be carried out
according to the approved SOPs.
• Testing will be carried out with validated and approved
method of analysis.
• The testing results will be noted in the approved test format
of the respective SOPs.
• The results will be reviewed and verified by the authorized
persons.
• The testing will be carried out on appropriate samples only.
• The expired reagents and chemicals will not be used for
testing.
• All the instruments used for the analysis will be calibrated and
the glassware, plastic ware or other items will be clean.
• The precautions will be taken, during performing the test as
mentioned in the SOP.
Good Laboratory Practice: Regulatory Requirements
• Instrument Calibration
• All the instruments used in the laboratory for
analysis will be calibrated.
• Calibration calendar will be maintained for the QC
instruments.
• The instrument will be tagged with the tags
showing the instrument detail and will carry a label
indicating its calibration status.
• Each instrument/equipment will have a history
card and only critical equipment will have its
logbook.
• The logbook will have the daily usage record of the
equipment and the history card will have its
maintenance records
• The instrument and glassware calibration will be
carried out as per the SOP.
Good Laboratory Practice: Regulatory Requirements
• Reagents/Materials Certification

• Container for laboratory reagents/materials must be labeled with information

such as date received, date opened, preparation date, expiration time, use
before etc.
• There will be a list of all media, chemicals, reagents, indicators, volumetric
solutions etc.
• Reference standard will be maintained appropriately and be calibrated against
traceable standard or reference materials.
• A standardization calendar will be maintained for the periodic standardization of
volumetric solutions and internal reference or working standards or check daily
for any standardization required.
• All the reagents or materials will be stored at its specified storage condition.
• All the volumetric glassware used must be calibrated; the apparatus and material
used in test should not interfere adversely with the test system
Good Laboratory Practice: Regulatory Requirements
• Reagents/Materials Certification
• There will be a list of all the chemicals and reagents, which
should be displayed on the respective rack.
• All the cupboards and drawers should be numbered, list of
materials kept inside each cupboard and drawers should be
maintained.
• Use the protective clothing as gloves, masks during reagent
preparation and standardization.
• Take all the precautions during handling hazardous chemicals
for e.g. add acid to water and never vice-versa.
• Avoid accidental spillage of acids and corrosive agents. Use
fume hood wherever possible.
• Stick all the symbols applicable to QC at the specified
locations eg: Hazardous waste, highly inflammable, Handle
with care, Highly Corrosive, Cytotoxic Waste etc.
• Never use graduated pipettes for quantitative analysis.
Good Laboratory Practice: Regulatory Requirements
• Documentation
QC should have the following document:
• Specification
• Sampling procedures
• Standard operating procedures
• Method of analysis
• Test reports and records
• Data from the environmental monitoring where required.
• Operation, calibration and maintenance record of instrument/equipment.
All the documents will be stored in a secured manner.
All the activity performed will be documented.
The record will be filled in such a way that it is readable.
The record should be filled only if the work is done or it may be online.
Documentation will be done as per SOP on Preparation and Control of the Documents.

• Cleaning of Laboratory and Clean Rooms

• There will be a cleaning schedule for the QC lab.
• The cleaning will be done according to it.
• The cleaning will be done with RO or WFI water and qualified cleaning agents.
• There will be a restricted entry into the clean rooms.
Good Laboratory Practice: Regulatory Requirements
• Cleaning of Glassware, Plastic ware and Others
• All analysts working in the QC lab should be educated and qualified analysts.
• They should be certified for the analysis as per the analyst qualification procedure.
• Test is invalid if unqualified analyst has carried it out.

• Laboratory Facility Certification

• The QC lab will be independent of the manufacturing area.
• Separate area will be provided for physico-chemical and microbiological analysis.
• QC lab will be designed appropriately to carry out the operations.
• Sufficient space will be provided for storage of test sample, reference samples, reference standard, reagents, media
and records.

• Sample/Material Tracking
• Any sample or material entering the QC lab will be entered in the respective inward register and then will be stored
at the specified location.
• Sufficient reference and control samples of the product and the starting materials are retained to permit future
examination.
• There will be a system for avoiding the mix up of the samples or materials.
• There will be a proper tracking record for each and every material, sample, and instrument and testing.
Preparation for Interview
Knowledge about
the Processes &
Knowledge Equipments
about the Dressing Sense
Company
Areas of
Improvement
Have Explaining
Seriousness – Personal
Avoid Gossiping Achievements
Command on
Language
Tips to Success in Career
• Be Self-Driven, Self-Motivated
• Develop abilities to Work Without Supervision,
Without Waiting for Directions
• Don’t restrict your work to specific
department, Learn Everything
• Keep Upgrading Knowledge by Referring
Current FDA sites, Pharma knowledge
THANK YOU FOR YOUR TIME

Questions?