GOOD
LABORATO
RY
PRACTICE
JOSEPHINE P. BARIUAN
INSTRUCTOR
GOOD LABORATORY
PRACTICE
GLP is an FDA regulation.
GLP is a formal regulation that was created
by the FDA (United States Foods and Drug
Administration) in 1978.
DEFINITION OF GOOD
LABORATORY PRACTICE
is a standardized way of planning, performing
and repor ting laboratory-based studies to
ensure a high standard of quality and reliability.
DEFINITION OF GOOD
LABORATORY PRACTICE
GL P embo d i es a s et o f pr i nci pl es tha t
provides a framework within which
laboratory studies are planned, performed,
monitored, archived and reported.
WHY WAS GLP CREATED?
In the early 70’s, FDA became aware
of cases of poor laborato practice all
over the US.
ey discovered a lot of fraudulent
activities and a lot of poor lab
practices.
WHY WAS GLP CREATED?
Examples:
Equipment not been calibrated to
standard form, therefore giving
wrong measurements
Incorrect/inaccurate accounts of the
actual lab study
Inadequate test systems
PURPOSE OF GLP’s in
Analytical Chemist
1. Ensure Accuracy and Precision
To obtain correct and consistent analytical
results.
To minimize errors and variability in sample
p re p a ra t i o n , m e a s u re m e n t , a n d d a t a
interpretation.
PURPOSE OF GLP’s in
Analytical chemist
2. Ensure Reproducibility
To make sure that results can be
reproduced by others under the same
conditions.
Essential for validating methods, publishing
results, or meeting regulato standards.
PURPOSE OF GLP’s in
Analytical chemist
3. Maintain Data Integrity and Traceability
To ensure that all data are well-documented,
veri able, and tamper-proof.
Suppo s auditability and transparency in
research or compliance settings.
PURPOSE OF GLP’s in
Analytical chemist
4. Promote Safety
To protect laborato personnel and the
environment from chemical hazards.
Helps prevent accidents, spills, and
contamination.
PURPOSE OF GLP’s in
Analytical chemist
5. Suppo Method Validation and Quality
Control
To verify that methods yield reliable results
suitable for their intended purpose.
Impo ant for standardization and
ce i cation of analytical methods.
PURPOSE OF GLP’s in
Analytical chemist
6. Comply with Regulato Requirements
Required by agencies like the FDA, EPA,
OECD, or ISO/IEC for labs doing regulated
work.
Ensures laboratories meet legal and
professional standards.
PURPOSE OF GLP’s in
Analytical chemist
7. Promote Ethical and Professional Conduct
E n c o u ra g e s h o n e st y, o b j e c t i v i t y, a n d
responsibility in repo ing results.
Helps avoid data manipulation, misconduct,
or falsi cation.
PURPOSE OF GLP’s in
Analytical chemist
8. Improve E ciency and Sustainability
Encourages organized work ows, proper
reagent use, and waste minimization.
Reduces costs and resource waste through
standardized practices.
GOOD LABORATORY
PRACTICES PRINCIPLES
1. Organization and Personnel
Responsibilities:
a. Ensure that all laborato personnel are quali ed,
trained, and understand their roles and
responsibilities. b.
b. e lab must have an organizational structure
that suppo s accountability and quality.
GOOD LABORATORY
PRACTICES PRINCIPLES
1. Organization and Personnel
Responsibilities:
c. Assign a study director or lead analyst.
d. Provide regular training and competency
assessments.
e. Promote a safety- and quality-oriented
culture.
GOOD LABORATORY
PRACTICES PRINCIPLES
2. Standard Operating Procedures (SOPs)
Use written, approved procedures for all routine
operations (e.g., sample handling, equipment
calibration, chemical storage).
SOPs ensure consistency, reduce errors, and
guide proper technique.
Must be readily accessible and regularly updated.
GOOD LABORATORY
PRACTICES PRINCIPLES
3. Equipment Calibration and Maintenance
All instruments must be routinely calibrated,
maintained, and qualif ie d to ensure accurate
results.
Keep logs of maintenance and calibration.
Use equipment within validated per fo rmance
ranges only.
GOOD LABORATORY
PRACTICES PRINCIPLES
4. Test and Reference Items
Chemicals, reagents, and reference standards
must be clearly labeled, pure, and properly stored.
Maintain a record of origin, batch number, and
expi .
Validate reference materials where applicable.
GOOD LABORATORY
PRACTICES PRINCIPLES
5. Documentation and Records
Ever ystep of the analytical process must be
recorded in a timely, complete, and accurate
manner.
Use permanent ink, avoid erasures.
All changes must be signed, dated, and justi ed.
Records must be retained according to regulato
standards.
GOOD LABORATORY
PRACTICES PRINCIPLES
6. Sample Handling and Chain of Custody
Samples must be collected, labeled, stored, and
tracked carefully to avoid contamination or mix-
ups.
Document the complete chain of custody.
Maintain storage conditions (e.g., temperature) as
required.
GOOD LABORATORY
PRACTICES PRINCIPLES
7. Quality Assurance (QA)
A QA unit should monitor that all work is done
acco rding t o G L P and st udy pro t o co ls,
independently from the analytical team.
Conduct internal audits and inspections.
Review data integrity and repo accuracy.
GOOD LABORATORY
PRACTICES PRINCIPLES
8. Study/Method Protocols
Each analysis must follow a detailed study plan or
method protocol, outlining objectives, materials,
procedures, and evaluation criteria.
Protocol deviations must be documented and
justi ed.
Helps ensure reproducibility and traceability.
GOOD LABORATORY
PRACTICES PRINCIPLES
9. Facilities and Environment
Laborato infrastructure should suppo clean,
organized, and safe working conditions.
Segregate areas for sample prep, analysis, and
waste disposal.
Control environmental factors (e.g., humidity,
lighting, ventilation).
GOOD LABORATORY
PRACTICES PRINCIPLES
10. Waste Disposal and Safety
Follow procedures for chemical waste segregation,
labeling, and disposal. All personnel must follow
laborato safety protocols.
Use proper PPE and emergency equipment.
Regularly review and practice safety procedures.
GOOD LABORATORY
PRACTICES PRINCIPLES
11. Data Integrity and Ethical Conduct
Ensure all dat a are aut hent ic, o r iginal, and
traceable. Never fabricate, falsify, or alter results
to mislead.
U p h o l d t ra n s p a re n c y, a c c o u n t a b i l i t y, a n d
professional honesty.
Respect con dentiality and intellectual prope y.
WHAT GOOD LABORATORY
MUST HAVE?
1. Well-Designed Physical Layout
o e lab must be structured to suppo smooth work ow,
safety, and separation of incompatible activities (e.g.,
wet chemist , weighing, instrument analysis).
o Includes separate areas for sample preparation, reagent
storage, instrument operation, and waste disposal.
o Good ventilation, lighting, and space planning prevent
cross-contamination and accidents.
WHAT GOOD LABORATORY
MUST HAVE?
2. Properly Calibrated Analytical Instruments
o Essential instruments like balances, pH meters,
spectrophotometers, titrators, HPLC, and GC
must be available, functional, and routinely
calibrated.
o Suppo s accurate and precise measurements.
o Includes maintenance logs and per fo rmance
veri cation.
WHAT GOOD LABORATORY
MUST HAVE?
3. High-Purity Reagents and Chemicals
o Use analytical- or reagent-grade chemicals to
ensure reliability of results.
o All chemicals should be clearly labeled with
concentration, preparation date, expi , and hazard
information.
o Stored under proper conditions (e.g., d , cool, away
from sunlight).
WHAT GOOD LABORATORY
MUST HAVE?
4. Sample Storage Facilities
o Includes refrigerators, freezers, desiccators, and
secure sample cabinets.
o Ensures integrity of samples before and after
analysis.
o Maintains correct conditions (temperature,
humidity, light exposure).
WHAT GOOD LABORATORY
MUST HAVE?
5. Standard Operating Procedures (SOPs) and
Documentation System
o A good lab must have a set of clear, up-to-date
SOPs and a reliable system for recording data
(notebooks or digital LMS).
o Enables consistency and reproducibility of results.
o Ensures traceability for audits or reviews.
WHAT GOOD LABORATORY
MUST HAVE?
6. Clean and Organized Workspaces
o Benches and equipment should be regularly
cleaned, labeled, and well-organized.
o Reduces risk of contamination or error.
o Enhances e ciency and safety.
WHAT GOOD
LABORATORY MUST
7. Safety Equipment HAVE?
e lab must contain:
Fire extinguishers, safety showers, eye wash
stations.
Fume hoods for volatile or toxic chemicals.
PPE: gloves, lab gown, goggles, face
shields/masks
Clearly labeled rst aid kits and emergency exits.
WHAT GOOD
LABORATORY MUST
8. Waste Disposal SystemHAVE?
Includes labeled waste containers for:
o Organic and inorganic chemicals.
o Sharps, broken glassware, and biological waste.
o Proper disposal protocols aligned with
environmental regulations.
WHAT GOOD LABORATORY
MUST HAVE?
9. Trained and Competent Personnel
Personnel must be trained in:
o Analytical techniques, equipment use, GLP, and
safety procedures.
o Ethical practices, documentation, and
troubleshooting.
WHAT GOOD LABORATORY
MUST HAVE?
10. Invento and Labeling System
A well-maintained system to track all reagents,
standards, glassware, and consumables.
Prevents sho ages and expi -related errors.
Enhances traceability and resource management.
WHAT GOOD LABORATORY
MUST HAVE?
11. Quality Control and Assurance Tools
o Includes ce i ed reference materials (CRMs),
internal standards, and pro ciency testing records.
o Helps validate methods and ensure accuracy of
results.
KEY BENEFITS OF GLP IN
ANALYTICAL CHEMISTRY
1. Ensures Accuracy and Reliability of Results
GLP minimizes experimental errors and
inconsistencies by promoting standardized methods
🔍
and careful documentation.
Bene t: Analytical results become dependable for
decision-making, research, and regulato
submission.
KEY BENEFITS OF GLP IN
ANALYTICAL CHEMISTRY
2. Promotes Reproducibility
By following consistent procedures and maintaining
proper records, other analysts can repeat
🔁
experiments and get the same results.
Bene t: Essential for validation, peer review, and
quality control.
KEY BENEFITS OF GLP IN
ANALYTICAL CHEMISTRY
3. Enhances Data Integrity and Traceability
GLP ensures all data are recorded properly, changes
are documented, and samples can be traced
📂
throughout the analysis.
Bene t: Builds trust in the data and allows for
e ective auditing and veri cation.
KEY BENEFITS OF GLP IN
ANALYTICAL CHEMISTRY
4. Suppo s Regulato Compliance
GLP aligns laborato operations with standards
required by agencies like the FDA, OECD, ISO, and
EPA.
📜 Bene t: Laboratories can operate legally and
qualify for ce i cations, grants, or international
collaboration.
KEY BENEFITS OF GLP IN
ANALYTICAL CHEMISTRY
5. Improves Laborato E ciency
Structured work ows, well-maintained equipment,
and SOPs save time, reduce waste, and improve
throughput.
⚙ Bene t: Increased productivity and cost-
e ectiveness in laborato operations.
KEY BENEFITS OF GLP IN
ANALYTICAL CHEMISTRY
6. Promotes Safety
GLP includes proper training, PPE use, and
emergency procedures to minimize chemical
exposure and accidents.
🧰 Bene t: Protects lab personnel, equipment, and
the environment.
KEY BENEFITS OF GLP IN
ANALYTICAL CHEMISTRY
7. Builds Professionalism and Ethical Conduct
Encourages responsible behavior, transparency, and
honesty in scienti c work.
🤝 Bene t: Strengthens the credibility of both the
individual analyst and the institution.
KEY BENEFITS OF GLP IN
ANALYTICAL CHEMISTRY
8. Facilitates Quality Assurance and Control
GLP promotes the use of reference standards,
control samples, and audits to monitor data quality.
📊 Bene t: Helps detect errors early and maintain
high analytical standards.
KEY BENEFITS OF GLP IN
ANALYTICAL CHEMISTRY
9. Enables Global Acceptance of Data
Following internationally recognized GLP principles
ensures results are accepted by regulators and
🌐
collaborators worldwide.
Bene t: Suppo s international trade, research,
and product development.
KEY BENEFITS OF GLP IN
ANALYTICAL CHEMISTRY
10. Encourages Environmental Responsibility
GLP includes proper chemical waste segregation and
disposal, helping reduce environmental harm.
🌱 Bene t: Promotes sustainability and regulato
compliance with environmental laws.
CONCLUSION
Good Laborator yPractices (GLP) ser v e as the foundation for
high- qu ality work in analytical chemistr y. By promoting
accuracy, reliability, safety, and ethical conduct, GLP ensures
that laborator yresults are scientif ically valid, reproducible, and
g l o b a l l y a c c ep ta b l e. F ro m p ro p er d o c u m en ta ti o n a n d
equipment maintenance to safety protocols and data integrity,
GLP enhances the credibility of analytical outcomes and
suppo s compliance with national and international standards.
Ultimately, adhering to GLP not only protects personnel and the
environment but also upholds the trust placed in scientif ic
research, industrial testing, and regulato processes.
