One of the fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies. The way in which study data, supporting human, animal and environmental safety assessment, is generated, handled, reported, retained and archived has continued to evolve in line with the introduction and ongoing development of supporting technologies.

1. Good Laboratory Practices

2. GXP Definitions
GLP GMP GCP
Good Laboratory
Practice (GLP) is a
quality system
concerned with the
organizational process
and the conditions under
which nonclinical health
and environmental
safety studies are
planned, performed,
monitored, recorded,
archived and reported.
Good Manufacturing
Practice is the part of
Quality Assurance which
ensures that products
are consistently
produced and controlled
to the quality standards
appropriate to their
intended use and as
required by the
Marketing Authorization
or product specification.
Good Manufacturing
Practice is concerned
with both production and
quality control.
Good Clinical Practice
(GCP) is an
international ethical and
scientific quality
standard for designing,
conducting, recording
and reporting trials that
involve the participation
of human subjects.
Good Laboratory Practices

3. WHY?
Good Laboratory Practices
• The goal of GLP is to certify that every step
of the analysis is valid.
• Standard Operating Procedures (SOP)
• Quality Assurance Unit (QAU)

4. • The QC laboratory provides service and is like a
manufacturing unit – its “products” include test
results, advice and investigations
• Needs
– buildings, personnel, resources
– equipment, raw materials
– quality assurance programme
Introduction
Good Laboratory Practices

5. Guidelines and Regulations
• THE OECD PRINCIPLES OF GOOD LABORATORY PRACTICE
(GLP)
– Non-clinical health and environmental safety studies covered by the principles of good laboratory
practice include work conducted in the laboratory, in greenhouses, and in the field.
• WHO Guidelines
• WHO Technical Report Series, No. 908, 2003, Annex 4
• WHO Technical Report Series, No. 822, 1992, Annex 1
Good Laboratory Practices
Organization for Economic Co-operation and Development (OECD) is an
international organization that works to build better policies for better lives

6. Organization and management
• Personnel
– Managerial and technical positions ensure operation in
accordance with quality systems or procedures for performing tests
and/or calibrations, validation and verification, and to initiate
actions to prevent or minimize such departures
Good Laboratory Practices

7. Organization and management
• Organizational chart and job descriptions
– Describes responsibility, authority and inter-relationships of all
personnel
• Supervision and training
– Adequate supervision of staff is provided, including trainees, by
persons familiar with the test and/or calibration, validation and
verification methods and procedures, as well as their purpose and
the assessment of the results
Good Laboratory Practices

8. Organization and management
– Technical manager/HODs, have overall responsibility for the
technical operations, and the provision of resources needed to
ensure the required quality of laboratory operations
• Safety
– Appropriate safety procedures shall be in place
– Safety Officers monitor compliance of safety policies within the
plant
Good Laboratory Practices

9. Laboratory Quality System
• Establishment, implementation and maintenance of quality system
appropriate to the scope of activities, including the type, range and
volume of testing and/or calibration, validation and verification
activities undertaken
– Policies, systems, programmes, procedures and instructions are in
place
• Documentation used in this quality system must be communicated,
made available, understood and implemented by the appropriate
personnel
Good Laboratory Practices

10. Laboratory Quality System
• Organogram: Organizational chart wherein operational and functional
activities are defined
• General quality assurance procedures followed throughout the facility
include knowledge and understanding of
– Standard Operating Procedures
– Entry Exit Procedures
– Gowning and Safety Procedures
– Good Documentation Procedures
– Change Controls
– Deviations/Incidents
• Training and maintaining competence of staff
Good Laboratory Practices

11. Laboratory Quality System
SOPs: Standard Operating Procedures are written, reviewed and
authorized and placed with controlled access
For administrative and technical operations, such as:
• Receipt, Internal labelling, quarantine and storage of materials in QC
e.g. samples, reference material, reagents, raw materials
– Sample Receipt, Management, Storage and Disposal.
– Appropriate installation of each instrument and equipment
• Sampling and inspection
• Testing materials, describing the methods and equipment used
• Qualification, analytical apparatus
Good Laboratory Practices

12. Laboratory Quality System
• Calibration, maintenance, cleaning, sanitation
• Documentation in the Vernacular (local) language employed in the
laboratory
• Temperature and Environmental monitoring
• Qualification of personnel for Product Testing
• Preparation and Control of biological reference materials
• Specific quality assurance procedures followed in QC Lab include
– Use of Protocols
– Use of AWS
– Use of Equipment Log Books
– Use of Test Request Forms (TRF)
– Use of Laboratory Notebooks (LNB) - TBD
Good Laboratory Practices

13. Laboratory Quality System
• Procedure for dealing with complaints often include reporting Out of
Specifications, OOLs, OOTs and Deviations.
• Corrective action and Preventive action - CAPA (for testing
discrepancies) as defined by QA
• Details of internal and external audits
• Safety measures
• Personnel matters including
– qualification, training, clothing, and hygiene
Good Laboratory Practices

14. Laboratory Test Results and Records
• All original observations or raw data, calculations and derived data,
calibration, validation and verification records, etc. and final results are
retained on records for an appropriate period of time in accordance to
national regulations ( as per Our defined SOPs)
– All Data captured on Work Sheets, Reports.
• Records to contain sufficient information to permit repetition of tests
and include, e.g.:
– Identity of the personnel involved in sampling, preparation and
testing of the samples
– Instruments, equipment, etc.
Good Laboratory Practices

15. Laboratory Test Results and Records
• Procedures are in place for identification, collection, indexing, access,
storage, maintenance and disposal of quality documentation and
technical records
• All final results are retained on records for an appropriate period of
time in accordance to national regulations
• The records of samples for legal proceedings should be kept according
to legal requirements.
Good Laboratory Practices

16. Laboratory Data Processing Equipment
• Includes computers, automated tests or calibration equipment
• Used for collection, processing, recording, reporting, storage or
retrieval of test and/or calibration data
• Laboratory Analytical Equipment's which produce raw data outputs
include
– Weighing balances
– Automated Instruments such HPLC/GC
– Stability Software's
– Software's such as Parallel Line Analysis and Probit Analysis
• Procedures in place to describe how:
– Changes are made, documented and controlled for information
– To protect and keep back-up data at all times
– To prevent unauthorized access or amendments to the data
Good Laboratory Practices

17. Personnel
• Competence ensured for activities, performing tests and/or
calibrations, validations or verifications, evaluation of results and
signing test reports, certificate of analysis, and calibration certificates
• Staff undergoing training – supervised, with formal assessment after
training
• Personnel must be qualified on the basis of appropriate education,
training, experience and/or demonstrated skills
Good Laboratory Practices

18. Personnel
• Permanently employed, or under contract
• Contracted personnel to be supervised and sufficiently competent,
motivated – work complying good practice of the laboratory
• Current job descriptions are in place for managerial, technical and key
support personnel
• Records of competence, educational and professional qualifications,
training, skills and experience
– Readily available, and include date of confirmation of competence,
plus criteria for confirmation and name of the confirming authority
Good Laboratory Practices

19. Premises
• Separate areas for receipt, storage, sample preparation and testing to
prevent contamination or mix-ups
• Cold Room, Freezers and Deep freezers for samples to be maintained
at low temperature conditions
• Controlled access to special testing areas such as Sterility Testing
• Separate areas for secure storage of samples, retained samples,
reagents, laboratory accessories, reference materials
• Safe storage of hazardous substances
• Fire regulations
• Flammable reagents, fuming and concentrated acids, bases, volatile
amines – safe storage separately
Good Laboratory Practices

20. Laboratory Safety
• Handling and disposal of wastes
– Decontaminate biomedical waste in dedicated autoclaves
– Liquid waste generated shall be drained off to kill tank after
decontamination in dedicated autoclave
– Yellow color bins – animal waste, blood and body fluids, stocks or
specimens of micro organisms, live or attenuated vaccines, media
culture(Biohazard/Biomedical)
– Red Color bins – Glassware and tips
– White Color bins – Sharps
– Needle Burners – incinerate needles
Good Laboratory Practices

21. Laboratory Do’s
• Wear Personnel Protective Equipment : Lab coats, appropriate shoes,
safety goggles (prescribed glasses) and gloves
• Keep work area neat and free of any unnecessary objects.
• Know emergency procedures
• Turn off all heating apparatus, gas valves, and water faucets when not
in use
• Keep the floor clear of all objects (e.g., ice, small objects, spilled
liquids, boxes)
• Immediately report any spills, accidents, or injuries
Good Laboratory Practices

22. Laboratory Do’s
• Follow all safety guidelines given in SOPs while testing
• Check the label to verify it is the correct substance before using it
• Handle hot glassware and apparatus using appropriate gloves.
• Use the laboratory chemical fume hood when there is a possibility of
release of toxic chemical vapors, dust, or gases.
• Always use a spatula or scoopula to remove a solid reagent from a
container.
• Document all procedures and results concurrently
• Follow GDP while making any entries in log books etc
Good Laboratory Practices

23. Laboratory Don’ts
• Do not sit on work benches
• Never use laboratory glassware for eating or drinking purposes.
• Eating, chewing of gum and drinking in laboratory is forbidden
• Performance or unauthorized experiments is strictly forbidden
• Never leave experiments while in progress
• Never attempt to catch falling objects
Good Laboratory Practices

24. Laboratory Don’ts
• Never fill a pipette using mouth suction. Always use a pipetting device.
• Never add water to a concentrated acid.
• Don’t use damaged glassware or equipment. In case of equipment
requiring repair notify supervisor immediately
• Do not directly touch any chemical with your hands.
• Never touch, taste, or smell any reagents or inhale the vapors.
• Follow appropriate containerization methods when handling biohazard
waste
Good Laboratory Practices

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