Good_Laboratory_Practice-(GLP)_VJ[1].pptx

Good Laboratory Practice (GLP),Organization for Economic Co-operation and Development(OECD),National GLP Compliance Monitoring Authority

1. Good Laboratory Practice (GLP) Presenter - Dr. Vijay R (JR-2) Peer Support- Dr. Kaustubh Bhardwaj (JR-2) Department of Pharmacology & Therapeutics King George’s Medical University, Lucknow, U.P. India Mail ID : [email protected]

2. Contents Introduction History of GLP Principles of GLP Scope of GLP Elements of GLP Summary 13 September 2025 Dr Vijay R 2

3. Specific learning objectives At the end of this teaching learning session, co-learners will be able to : Define Good laboratory practice Describe Principles of GLP Enumerate different Elements of GLP 13 September 2025 Dr Vijay R 3

4. Abbreviations used GLP Good Laboratory Practice FDA Food and Drug Administration NGCMA National GLP Compliance Monitoring Authority QAU Quality assurance unit OECD Organization for Economic Co-operation and Development SOP Standard Operating Procedure NDA New Drug Application 13 September 2025 Dr Vijay R 4

5. Introduction A quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported 13 September 2025 Dr Vijay R 5

6. History 1970s: Concerns about the quality & reliability of safety data emerge due to cases of scientific misconduct & poor laboratory practices 1976: The U.S. (FDA) proposes the first GLP regulations 1981: OECD officially adopts the Principles of GLP (global standard) 1990s onwards: OECD continues harmonizing GLP worldwide 2002: NGCMA was established under the Department of Science & Technology in India 13 September 2025 Dr Vijay R 6

7. Acquiring GLP Certification in India 13 September 2025 Dr Vijay R 7 Apply to the NGCMA for a pre-evaluation   Conduct an audit to identify areas of non-compliance with GLP standards Receive a GLP certificate after successful inspection

8. Principles Test Facility Organization & Personnel Quality Assurance Programme Facilities Apparatus, Material and Reagents Test Systems 13 September 2025 Dr Vijay R 8

9. Test and Reference Items Standard Operating Procedures Performance of the Study Reporting of Study Results Storage and Retention of Records and Materials 13 September 2025 Dr Vijay R 9

10. Scope GLP applies to non-clinical safety testing of a wide range of test items Purpose of testing is to gather data on safety and properties of test items related to human health and/or the environment 13 September 2025 Dr Vijay R 10 Pharmaceuticals products, Pesticides, Cosmetics, Veterinary drugs, Food and feed additives & Industrial chemicals

11. Elements of GLP 13 September 2025 Dr Vijay R 11 Facility Animal facilities Test/ Control article Staff Documentations

12. Facility Laboratory facilities should have enough space to prevent issues like overcrowding, mix-ups between projects, or contamination All equipment must be appropriate for its purpose , and it should be regularly checked, calibrated and maintained to ensure it works accurately and reliably 13 September 2025 Dr Vijay R 12

13. Storage of test items under different conditions: Storage of control items Handling of volatile materials Weighing Mixing of different dose formulations, e.g., in the diet Storage of prepared dose formulations 13 September 2025 Dr Vijay R 13

14. Animal facilities Located away from testing laboratories preferably in a separate building Separate areas for animals of different species and studies Contamination risk is reduced by barrier system Separate areas for diagnosis, treatment and control of laboratory animal diseases 13 September 2025 Dr Vijay R 14

15. Test/ Control article Identity, strength, purity, composition & other imp. features of each batch of the test & control articles must be checked & recorded The stability of both test & control articles should also be tested All items must be stored under proper conditions and each container should be clearly labeled with its name, batch number After the study ends, any leftover test items should be safely disposed 13 September 2025 Dr Vijay R 15

16. Staff 13 September 2025 Dr Vijay R 16

17. Sponsor Person or organization that starts and funds a study, either by financially or other resources needed to carry it out Responsibilities of sponsor: Designate a study director before the study Assure that there is an QAU Any deviations from GLP rules, reported by the QAU, are shared with the study director and that corrective actions are taken & properly recorded 13 September 2025 Dr Vijay R 17

18. Study director Responsible for the overall conduct of the study & final report Approve the study plan & any amendments to the study plan by dated sign Sign and date the final report to confirm you are responsible for the accuracy of the data and to show how well the study follows the GLP rules 13 September 2025 Dr Vijay R 18

19. Management Without full support and active involvement from management and all staff, GLP systems won’t be trusted and won’t work properly 13 September 2025 Dr Vijay R 19

20. Quality assurance unit (QAU) Responsible for checking each study to make sure that the facilities, equipment, staff, methods, procedures, records and controls follow the rules Responsibilities of QAU: 1. Is the study being conducted in accordance with the protocol? 2. Is the study being conducted in accordance with relevant SOPs? 3. Is the study being conducted in accordance with the GLP regulations? 13 September 2025 Dr Vijay R 20

21. Who appoints the Study Director before the initiation of the study? a) QAU b) Sponsor c) GLP Committee Ans: b) Sponsor 13 September 2025 Dr Vijay R 21

22. 2) Who is responsible for the overall conduct of the study & final report? a) Study director b) Sponsor c) QAU Ans: a) Study director 13 September 2025 Dr Vijay R 22

23. 3) Who is responsible for reporting to the sponsor if there are any deviations from GLP rules during the study? a) Study director b) Sponsor c) QAU Ans: c) QAU 13 September 2025 Dr Vijay R 23

24. Documentation 13 September 2025 Dr Vijay R 24

25. Protocol A key document that the study director uses to explain how the study will be organized to the study team and third parties like the QAU or the sponsor All staff involved in the study should have an easy access to a copy of the protocol 13 September 2025 Dr Vijay R 25

26. It should contain the following details Identification by a study number Title and statement of purpose Identification of test (and control) items Names and addresses of the sponsor, the test facility, and test site(s) Name of the study director and other responsible personnel Proposed dates & Experimental design 13 September 2025 Dr Vijay R 26

27. SOP It outlines the complete process in advance with the stepwise essential information Contents: Study Design, Equipment and Materials, Management & Responsibilities, Standard Scientific Techniques, Procedures, Monitoring, Documentation and Reporting   Characteristics: Readability, Understanding, Availability 13 September 2025 Dr Vijay R 27

28. Results and reports Laboratory should have descriptive documents, which are records describing what actually happened during the course of the experimentation Records are the qualitative and quantitative results of the study 13 September 2025 Dr Vijay R 28

29. The specific elements required by GLP in the study report: Name and address of the test facility Dates of start and finish of the experiment Name of the study director Study objectives Details of test item(s) and vehicle(s) Details of dosing, route, and duration 13 September 2025 Dr Vijay R 29

30. Results Statistics Discussion & References GLP Compliance Statement from the study director QA statement of inspections/audits Signed/dated reports from responsible scientists 13 September 2025 Dr Vijay R 30

31. Archiving The FDA audits archiving systems ( NGCMA in India ) Retention requirement for documentation, raw data & specimens: 13 September 2025 Dr Vijay R 31 At least 2 years after FDA approval of a research/marketing application or At least 5 years after submission of study results to the FDA

32. 13 September 2025 Dr Vijay R 32 Non- Regulated GLP GCP GMP

33. Summary GLP is a quality system that ensures the reliability and integrity of non-clinical laboratory studies Principles - Test Facility Organization & Personnel, Quality Assurance Programme, Facilities, Test Systems, SOPs, Reporting of Study Results, Archiving Scope- GLP applies to Pharmaceuticals products, Pesticides, Cosmetics, Veterinary drugs, Food and feed additives NGCMA 13 September 2025 Dr Vijay R 33

34. Further reading: Good Clinical Practice (GCP) Good Manufacturing Practice (GMP) 13 September 2025 Dr Vijay R 34

35. References: WHO Handbook on Good Laboratory Practice (GLP): quality practices for regulated non-clinical research and development. 2nd edn . Geneva: WHO, 2009 Medhi B, Prakash A, Bioassay, General Considerations In Experimental Pharmacology, Practical Manual of Experimental and Clinical Pharmacology, 2nd edition. New Delhi: Jaypee Brothers; 2017: page no- 163-165 Maiti R. Good Laboratory Practice. In: Postgraduate Topics in Pharmacology . 3rd ed. Delhi: Paras Medical Books Pvt. Ltd.; 2020. p. 78‑83. https://dst.gov.in/ngcma 13 September 2025 Dr Vijay R 35

36. Specific learning objectives achieved: By the end of teaching learning session, co-learners are now able to- Define Good laboratory practice Describe Principles of GLP Enumerate different Elements of GLP 13 September 2025 Dr Vijay R 36

37. Audience Question? 13 September 2025 Dr Vijay R 37

38. Questions Definition of GLP? What are the principle's of GLP? Full form of NGCMA? What are the elements of GLP ? 13 September 2025 Dr Vijay R 38

39. Thank You 13 September 2025 Dr Vijay R 39