Good Laboratory Practices Pharmaceutical Quality Assurance
1. 4.8.7 T QUALITY ASSURANCE
TECHNIQUES
SAVITRIBAI PHULE PUNE UNIVERSITY
Syllabus of Final Year B. Pharmacy
(EFFECTIVE FROM ACADEMIC YEAR 2018-19)
PATTERN 2015
2. Hello!
I am Shrikant Kavitake
M Pharm (Pharmaceutics)
DATTAKALA COLLEGE OF PHARMACY
Swami-Chincholi, Daund, Pune.
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4. Good Laboratory Practices (GLP)
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Medicines and Healthcare products Regulatory Agency- UK
which defines GLP as: “Good Laboratory Practice (GLP)
consists a set of principles that provides a framework within
which laboratory studies are planned, performed, monitored,
recorded, reported and archived”.
The phrase Good Laboratory Practice or GLP specifically
refers to a quality system of management controls for
research laboratories and organizations to ensure the
uniformity, consistency, reliability, reproducibility, quality, and
integrity of chemical (including pharmaceuticals) non-clinical
safety tests; from physiochemical properties through acute to
chronic toxicity tests.
5. Contin…
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These studies are undertaken to generate data by which
the hazards and risks to users, consumers and third parties,
including the environment, can be assessed for
pharmaceuticals (only preclinical studies), agrochemicals,
cosmetics, food additives, feed additives and contaminants,
novel foods, biocides, detergents etc.
GLP helps assure regulatory authorities that the data
submitted are a true reflection of the results obtained
during the study and can therefore be relied upon when
making risk/safety assessments.
GLP is an FDA regulation.
6. HISTORY
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• The term GLP was first used in New Zealand in 1972.
• GLP was first introduced in New Zealand and Denmark in 1972,
and later in the US in 1978 in response to the Industrial BioTest
Labs scandal.
• GLP is a formal regulation that was created by the US FDA
(United states food and drug administration) in 1978.
• GLP was instituted in US following cases of fraud generated by
toxicology labs in data submitted to the FDA by pharmaceutical
companies. 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.
7. Cont…
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• Assure the quality and integrity of safety Nonclinical
laboratory studies
• Although GLP originated in the United States, it had a
world wide impact.
• Non-US companies that wanted to do business with
the United states or register their pharmacies in the
United States had to comply with the United States
GLP regulations.
• They eventually started making GLP regulations in
their home countries.
• CFR: Code of Federal regulations
8. WHY WAS GLP CREATED?
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• In the early 70’s FDA became aware of cases of poor laboratory
practice all over the United States.
• FDA decided to do an in-depth investigation on 40 toxicology
labs.
• They discovered a lot fraudulent activities and a lot of poor lab
practices.
• Examples of some of these poor lab practices found were
1. Equipment not been calibrated to standard form, therefore
giving wrong measurements.
2. Incorrect/inaccurate accounts of the actual lab study.
3. Inadequate test systems.
9. Example
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One of the labs that went under such an investigation made
headline news.
• The name of the Lab was Industrial Bio Test. This was a big
lab that ran tests for big companies such as Procter and
Gamble.
• It was discovered that mice that they had used to test
cosmetics such as lotion and deodorants had developed cancer
and died.
• Industrial Bio Test lab threw the dead mice and covered
results deeming the products good for human consumption.
• Those involved in production, distribution and sales for the lab
eventually served jail time.
10. OBJECTIVES OF GLP
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GLP makes sure that the data submitted are a true reflection of
the results that are obtained during the study.
GLP also makes sure that data is traceable.
Promotes international acceptance of tests.
11. GLP Principles
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1. Organization and Personnel
Management-Responsibilities
Sponsor-Responsibilities
Study Director-Responsibilities
Principal Investigator-Responsibilities
Study Personnel-Responsibilities
2. Quality assurance program
Quality Assurance Personnel
3. Facilities
Test System Facilities
Facilities for Test and Reference Items
4. Equipment, reagents and Materials
12. Cont…
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5. Test systems
Physical/Chemical
Biological
6. Test & Reference items
7. Standard operating procedures
8. Performance of Study
Study Plan
Conduct of Study
9. Reporting of results
10. Archival - Storage of Records and Reports
13. Basic elements in GLP
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• Personnel
Sponsor
Management
Study director
Quality Assurance
• Facility
Laboratory
Operation
Animal care
Equipment
Reagents
Storage
• Documents
Standard Operating Protocols
Reports
Archiving
• Test and Control Articles
Characterization
Handling
Storage
14. Personnel
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Qualification of personnel: The assumptions is that in order to conduct
GLP studies with right quality a couple of things are important;
1)There should be sufficient number.
2)The personnel should be qualified.
Sponsor: Person who initiates and supports non-clinical laboratory
study, a person who submits non-clinical study to FDA or testing
facility that initiates and conducts the study.
Facility management: Responsibilities of facility management is well
defined. They designate a study director, as well as assure quality
assurance unit is available, test and control articles are characterized.
15. Cont…
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Study director:
He has overall responsibilities for technical conduct safety studies, as
well as interpretation, analysis, documentation and reporting of
results.
Quality Assurance unit:
The quality assurance unit (QAU) serves an internal control function.
It is responsible for monitoring each study to assure management
that facilities, equipment, personnel, methods, practices, records,
controls, SOPs, final reports (for data integrity), and archives are in
conformance with the GLP/GALP
16. Facilities
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• Suitable size, construction and location.
• Adequate degree of separation of the different activities.
• Isolation of test systems and individual projects to protect from
biological hazards.
• Suitable rooms for the diagnosis, treatment and control of
diseases.
• Storage rooms.
Apparatus of appropriate design and adequate capacity.
• Documented Inspection, cleaning, maintenance and calibration
of apparatus.
• Apparatus and materials not to interfere with the test systems.
• Chemicals, reagent and solutions should be labelled to indicate
identity, expiry and specific storage instructions.
17. Cont…
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Test Systems
• Physical and chemical test systems.
• Biological test systems.
• Records of source, date of arrival, and arrival conditions
of test systems.
• Proper identification of test systems in their container or
when removed.
• Cleaning and sanitization of containers.
• Pest control agents to be documented.
18. Cont…
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Test and Reference Items
• Receipt, handling, sampling and storage
• Characterization.
• Known stability of test and reference items.
• Stability of the test item in its vehicle (container).
• Experiments to determine stability in tank mixers used in
the field studies.
• Samples for analytical purposes for each batch.
19. Standard Operating Procedures (SOP)
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Written procedures for a laboratories program.
They define how to carry out protocol specified activities.
Most often written in a chronological listing of action steps.
They are written to explain how the procedures are suppose to
work.
Routine inspection, cleaning, maintenance, testing and
calibration.
Actions to be taken in response to equipment failure.
Keeping records, reporting, storage, mixing, and retrieval of
data.
Definition of raw data.
Analytical methods.
20. Performance of the Study
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• Prepare the Study plan.
• Content of the study plan.
› Identification of the study.
› Records.
› Dates.
› Reference to test methods.
› Information concerning the sponsor and facility.
• Conduct of the study.
21. Reporting of Study Results
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• Information on sponsor and test facility.
• Experimental starting and completion dates.
• A Quality Assurance Program Statement.
• Description of materials and test methods.
• Results.
• Storage (samples, reference items, raw data, final reports)
etc.
22. Storage and Retention of
Records and Materials
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– The study plan, raw data, samples.
– Inspection data and master schedules.
– SOPs.
– Maintenance and calibration data.
– If any study material is disposed of before expiry the
reason to be justified and documented.
– Index of materials retained.
23. Do this for GLP
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• Keep the things at its location after use.
• Store heavy things at bottom & if possible on Trollies.
• Give name of location to everything.
• Follow “Everything has the place & Everything at its place”
principle.
• Prepare location list & display it.
• Put ladders for things stored on top.
• Identify everything with its name/ purpose.
• Follow “FIFO” to prevent old accumulation for laboratory
chemicals.
24. Benefits of GLP
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• It will give better image of company as a Quality producer in
Global market.
• Provide hot tips on analysis of data as well as measure
uncertainty and perfect record keeping.
• Provide guideline for doing testing and measurement in
detail.
• Provide guidelines and better control for maintenance of
instruments, environment control, preservation of test
records etc.
