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.
2. What is GLP?
Good Laboratory Practice (GLP) is a quality system concerned with the
organisational process and the conditions under which non-clinical health
and environmental safety studies are planned, performed, monitored,
recorded, archived and reported.
(OECD , 1997)
(OECD , 1997)
3. Historical Background
• In the early 1970s, the US Food and Drug Administration (FDA) mounted a series of
investigations in toxicology laboratories throughout the USA.
• The FDA investigated a number of cases of poor practice in toxicology laboratories
throughout the USA
• Results of this investigation in about 40 laboratories revealed many cases of poorly
managed studies, insufficient training of personnel, and some cases of deliberate
managed studies, insufficient training of personnel, and some cases of deliberate
fraud.
4. Historical Background
The FDA investigation Findings:
• 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
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
5. Historical Background
The results of these investigations revealed a situation that could only be dealt with by
imposing binding regulations. These regulations are the GLP regulations.
• Introduce a new regulation to cover NON-CLINICAL SAFETY STUDIES
Good Laboratory Practice regulations Draft USA GLP in 1976
• Good Laboratory Practice regulations Draft USA GLP in 1976
• An enforceable USA regulation in 1979
GLP
promotes
QUALITY & VALIDIDTY
of Test Data
6. GLP - TIMELINE
FDA promulgated the Good
Laboratory Practice (GLP)
National GLP-Compliance
Monitoring Authority
Early 1970s
FDA became aware of cases of poor laboratory
practice all over the US decided to do an in-depth
Investigation on 40 toxicology labs.
GLP was first
introduced in New
Zealand
Laboratory Practice (GLP)
Regulations
21 CFR, Part 58
An organization named
OECD produced GLP
principles that are
international standard
1972 1981
1978
Monitoring Authority
was established by the
Department of Science &
Technology
India becomes fullmember
for Mutual
Acceptance of Data
(MAD) in the OECD's
Working Group on GLP
2011
2002
Organization for
Economic
Cooperation and
Development
7. Promotes
international
acceptance of tests
GLP also makes sure
that not to indulge in
any fraud activity by
labs
GLP makes sure that
the data submitted
are a true reflection
of the results that are
Objectives of GLP
International
acceptance
Ensure Honesty
labs
True reflection
of the results that are
obtained during the
study.
8. Scope of GLP (OECD)
• Principles of GLP apply to all non-clinical health and environmental
safety studies required by regulations for the purpose of registering
or licensing -
• Pharmaceuticals
• Pesticides
• Pesticides
• Food and feed additives
• Cosmetic products
• Veterinary drug products and similar products
• Industrial chemicals
10. THE FUNDAMENTAL POINTS OF GLP
• The GLP regulations set out the rules for good practice and help researchers
perform their work in compliance with their own pre-established plans and
standardized procedures.
• The regulations are not concerned with the scientific or technical content of
the research programmes. Nor do they aim to assess the scientific value of
the research programmes. Nor do they aim to assess the scientific value of
the studies.
• All GLP texts, irrespective of their origin, 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.
11. 1. Resources
Organization and personnel
• GLP regulations require that the structure of R&D organizations and the
responsibilities of R&D personnel be clearly defined.
• GLP also stresses that there should be sufficient staff to perform the tasks required.
• The qualifications and the training of staff must also be defined and documented.
• The qualifications and the training of staff must also be defined and documented.
Facilities and equipment
• The regulations emphasize the need for sufficient facilities and equipment to perform
the studies.
• All equipment must be in working order. To ensure this, a strict programme of
qualification, calibration and maintenance must be adopted.
12. 2. Characterization
• In order to perform a study correctly, it is essential to know as much as possible
about the materials used during the study.
• For studies that evaluate the properties of pharmaceutical compounds during non-
clinical studies, it is a prerequisite to have details about the test item and the test
system (often an animal or plant) to which the test item is to be administered.
system (often an animal or plant) to which the test item is to be administered.
13. 3. Rules
Protocols and written procedures
• The main steps of research studies are prescribed in the study plan or protocol.
• Being able to repeat studies and obtain similar results is a sine qua non of mutual
acceptance of data and, indeed, a central tenet of the scientific method, so the
details of routine procedures must also be available to scientists involved in the
details of routine procedures must also be available to scientists involved in the
study.
• However, the protocol, which provides the experimental design and timeframe for the
study, does not contain all the technical detail necessary to conduct the study. These
details are found in written standard operating procedures (SOPs).
• With the protocol and the SOPs it should be possible to repeat the study exactly, if
necessary.
14. 4. Results
Raw data
• All studies generate raw data. These are the outcome of research and form the basis for
establishing scientific interpretations and arriving at conclusions. The raw data must also
reflect the procedures and conditions of the study.
Final Report
Final Report
• The study report contains an account of the way in which the study was performed,
incorporates the study results and includes the scientific interpretation of the data. The
report is provided to regulatory authorities as part of the submission for registration and
marketing approval.
Archives
• Storage of records must ensure safekeeping for many years and allow for prompt retrieval.
15. 5. Quality Assurance
• Quality assurance (QA), as defined by GLP, is a team of persons (often called the
quality assurance unit – QAU) charged with assuring management that GLP
compliance has been attained within the laboratory.
QA must be independent from scientists involved in the operational aspects of the
• QA must be independent from scientists involved in the operational aspects of the
study being performed. QA functions as a witness to the whole non-clinical research
process.
16. THE OECD GLP PRINCIPLES
• GLP started when the FDA issued mandatory GLP requirements on 20 June 1979.
• The FDA subsequently revised these regulations a number of times but it has
never altered its scope; regulations still apply to non-clinical safety studies
applied to drugs.
• Preliminary pharmacological studies and pharmacokinetic studies not designed
to test safety are still exempt from GLP requirements.
• A little later, the OECD introduced the OECD Principles for GLP (GLP Principles)
concerning the safety testing of any chemical substance.
18. GLP in our country
National GLP-compliance Monitoring Authority was established by the
• National GLP-compliance Monitoring Authority was established by the
Department of Science & Technology
• Approval of the Union Cabinet on April 24, 2002
• Full-member for Mutual Acceptance of Data (MAD) in the OECD's Working
Group on GLP from March, 2011
• The Authority has certified 31 TF in India as GLP compliant
19. Scope of GLP application to NGCMA (India)
• Physical-chemical testing
• Toxicity studies
Mutagenicity studies
• Toxicity studies
• Mutagenicity studies
• Environmental toxicity studies on aquatic and terrestrial organisms
• Studies on behaviour in water, soil and air, bio-accumulation
• Studies on effects on natural ecosystems
• Analytical and chemical testing
20. GLP CERTIFICATION PROCESS
Pre-Inspection of TF/Lab is carried out by
GLP Inspectors, followed by a final Inspection
GLP Compliance
Certification
(Validity: 3 Years)
Application Inspection
Report
Submission
Certification
Test Facilities/Laboratories have to apply
in the prescribed application form
Report prepared by
Inspection Team
is put to the Technical Committee Recommendation
to Chairman, NGCMA
