GOOD LABORATORY PRACTICES by dr Saurabh maurya

GLP guidelines

1. GOOD LABORATORY PRACTICES Dr. Saurabh Maurya Junior Resident – 2 King George Medical University Lucknow

2. Definition : “ Quality system concerned with organizational process and the condition under which a non-clinical health and environmental safety study is planned, performed, monitored, recorded, archived and reported.”

3. Applies to non-clinical studies conducted for the assessment of safety or efficacy of chemicals. GLP helps assure regulatory authorities that data submitted are a true. GLP originated in USA IN THE 1970s.

4. Famous Example : Lab named “ Industrial Bio Test” (IBT) Runs test for Procter and Gamble Mice used to test lotion and deodorants Developed cancer and died Despite IBT approved products good for human use.

5. Why GLP ? Development of quality test data Mutual acceptance of data Avoid duplication of data Avoid technical barriers to trade Protection of human health and environment

6. Scope : Non-clinical safety testing of test items contained in – - Pharmaceutical products - Pesticide products - Cosmetic products - Veterinary drugs - Food additives - Industrial chemicals

7. Objectives: GLP make sure - that data submitted are a true reflection of results. - that data is traceable. Promotes international acceptance of tests.

8. Guidelines and Precautions: Always wear personal protective equipments . eg – Apron, Gloves, glasses, shoes, radioactive shield and batch. Read procedure before carrying out the experiment. Before starting experiment, label your material. Check label on container before taking out any substance. Be aware of all safety measures.

9. The GLP Principles Test facility organization and personnel Quality assurance program Facilities Apparatus materials and reagents Test Systems Test and reference items Performance of study Reporting of study results Storage and retention of records

10. 1. Test facility organization and personnel Test facility management’s responsibilities Study director’s responsibilities Principal investigator’s responsibility Study personnel’s responsibilities

11. 2. Quality Assurance Program Responsibilities of QA Personnel QA members not to be involved in the study being assured. Access to the updated study plans and SOP’s. Document verification Inspection – study based inspections - Facility based inspections - Process based inspections

12. 3. Facilities Suitable Size, construction and location Adequate degree of separation of different activities Isolation of test systems and individual project from biological hazards Suitable rooms for diagnosis, treatment and control of disease. Storage rooms for supplies and equipment Proper handling and disposal of waste

13. 4.Apparatus, Material and Reagents Apparatus of appropriate design and adequate capacity Documented inspection, cleaning, maintenance and calibration of apparatus. Apparatus and materials not to interfere with the test system. Chemicals, Reagent and solutions should be labeled to indicate identity, expiry and specific storage instructions.

14. 5,6. Test Systems , Test and reference items

15. 7. Performance of Study Study plan Contents of study plan Dates Test methods Records A list of records to be retained Conduct of study

16. 8. Reporting of study results Content of final report Identification of study, the test item and reference item Information on sponsor and test facility – Name, address, scientist etc Dates Statements Description on material and test method Results Storage (of sample data, raw data, final report etc )

17. 9. Storage and retention of records and materials What to retain The study plan, raw data, samples Inspection data , final report Report of all inspection performed Records of qualification, training experience, job description Validation data SOPs

18. GLP In INDIA

19. THANK YOU