GLP

1. NOIDA INSTITUTE OF ENGINEERING AND
TECHNOLOGY
(PHARMACY INSTITUTE)
PHARMACOLOGICAL AND TOXICOLOGICAL
SCREENING METHODS (MPL-202T)
TOPIC- Principles of Good Laboratory Practice(GLP)
SUBMITED TO SUBMITED BY-
Dr. SAUMYA DAS SHIVAM YADAV
M.PHARM
(PHARMACOLOGY SEM-2)

2. CONTENT
• Good Laboratory Practice(GLP)
• THINGS ON WHICH GLP APPLIED
• PRINCIPLE OF GLP
• History
• ORGANISATION OF ECONOMIC COOPERATION
AND DEVELOPMENT(OECD)
• GLP COMPLETE PROCEDURE AND PERSONNEL
RESPONSIBILITIES

3. GOOD LABORATORY PRACTICES
• In the experimental (non-clinical) research
arena, good laboratory practice or GLP is 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)
nonclinical safety tests; from physio-chemical
properties through acute to chronic toxicity
tests.

4. THINGS ON WHICH GLP APPLIED
• GLP applies to non-clinical studies conducted
for the assessment of the safety or efficacy of
chemicals (including
• pharmaceuticals) to man, animals and the
environment.
• laboratory safety - appropriate gloves, glasses
and clothing
• to handle lab materials safely.

5. PRINCIPLE OF GLP
• The principles of GLP aim to ensure and
promote safety, consistency, high quality, and
reliability of chemicals in the process of non-
clinical and laboratory testing. GLP is not
limited to chemicals and also applies to
medical devices, food additives, food
packaging, color additives and other non-
pharmaceutical products or ingredients.

6. HISTORY
• GLP was first introduced in New Zealand and Denmark
in 1972. GLP was instituted in US following cases of
fraud generated by toxicology labs in data submitted to
the FDA by pharmaceutical companies. Industrial Bio
Test Labs (IBT) was the most notable case, where
thousands of safety tests for chemical manufacturers
were falsely claimed to have been performed or were
so poor that police investigators could not piece
together what work had been done even though IBT
superficially delivered the test results their contracts
with the manufacturers specified.

7. • These issues were made public in the hearings at
the US Congress, which led to the FDA's
publication of Proposed Regulations on GLP in
1976, with establishment of the Final Rule in June
1979 (21 CFR 58). The Environmental Protection
Agency (EPA) had also encountered similar
problems in data submitted to it, and issued its
own draft GLP regulations in 1979 and 1980,
publishing the Final Rules in two separate parts
(40 CFR 160 and 40 CFR 792) in 1983

8. ORGANISATION OF ECONOMIC
COOPERATION AND DEVELOPMENT
Following Decision C(97),186/Final of the OECD
Council, data generated in the testing of chemicals in one
OECD Member Country, in accordance with OECD Test
Guidelines and the Principles of GLP are accepted in all
other OECD Member Countries. OECD:
ENV/MC/CHEM(98)17 part two GLP is a quality system
concerned with the organizational process and conditions
under which non-clinical health and environmental safety
studies are planned, performed, monitored, recorded,
archived and reported.

9. GLP COMPLETE PROCEDURE AND
PERSONNEL RESPONSIBILITES
1. Organization and Personnel
• Management-Responsibilities
• Sponsor-Responsibilities
• Study Director-Responsibilities
• Principal Investigator-Responsibilities
• Study Personnel-Responsibilities

10. 2. Quality assurance program
• Quality Assurance Personnel
3. Facilities
• Test System Facilities
• Facilities for Test and Reference Items
4. Equipment, reagents and materials
5. Test systems
• Physical/Chemical
• Biological

11. 6. Test and reference items
7. Standard operating procedures
8.Performance study
• Study Plan
• Conduct of Study
9. Reporting of result
10.Archival - Storage of Records and Reports
OECD Guidelines for the Testing of Chemicals
.

12. OECD Guidelines for the Testing of
Chemicals
• OECD publishes OECD Guidelines for the
Testing of Chemicals, which are guidelines that
usually have to be followed for GLP
compliance. They are widely required by
agencies doing risk assessments of chemicals

13. THANK YOU