The document discusses Good Laboratory Practice (GLP), which refers to a quality system for non-clinical safety studies. It outlines the history and regulations around GLP from agencies like the FDA and OECD. Key aspects of GLP include establishing a quality assurance unit, appointing a study director, using standard operating procedures and calibrated equipment, qualified personnel, documentation, auditing, and archiving materials. GLP is meant to ensure the quality and validity of non-clinical safety studies.

1. GOOD LABORATORY PRACTICE

2. Do, what you write Write, what you do

3. GLP goes hand-in-hand with QA (quality assurance) GLP without quality is useless

4. USA: FEDERAL DRUG ADMINISTRATION  1906: Food, Drug and Cosmetic Act FDA has to prove the poor quality for withdrawing a drug from the market  1938: Manufacturer has to effectiveness of a drug  1962: Manufacturer has to prove safety and effectiveness of ‘New Drugs’

5. USA FEDERAL DRUG ADMINISTRATION  1979: Good Laboratory Practice Regulations (Revised several times)  Other agencies had endorsed the concept Eg: Environmental Protection Agency (EPA)

6. GLP is not an Act/Legislation/Statute GLP is a regulation/guideline

7. Code of Federal regulations (Food and Drug Administration) Part 58 Good Laboratory practice for non-clinical Laboratory studies

8. Organisation for Economic Co-operation and Development (OECD) 1997 Principles of Good Laboratory Practice Objective To promote the quality and validity of test data used for determining the safety of chemicals and chemical products

9. Scope  Industrial chemicals  Pharmaceuticals  Veterinary drugs  Pesticides, Cosmetics  Food additives preservatives  Basic Research  Any laboratory procedure

10. What GLP is not  Excellence of a laboratory  Quality of an organisation  Quality of a product  Professional competence

11. Then, what is GLP ? GLP indicates quality of a study/procedure.

12. Definition Good Laboratory Practice 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)

13. Acceptability Credibility

14. Do not assume anything Good science = Compliance

15. Do not invent good practice Compliance with national legislation Compliance with national standards Compliance with international standards Validation of own standards

16. Terminology  Quality System  Quality and Requirement  Calibration and Traceability  Standard  Reference Material  Standardisation/validation  Accreditation  Inter-laboratory Comparison  Proficiency Testing  Auditing

17. Major Components  Creation of QAC; QUALITY ASSURANCE UNIT  Appointment of a STUDY DIRECTOR  Need for written protocols; SOPs STANDARD OPERATING PROCEDURES  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument  Collection and analysis of data by QUALIFIED PERSONS

18. Major Components  Creation of QAC; QUALITY ASSURANCE UNIT  Appointment of a STUDY DIRECTOR  Need for written protocols; SOPs STANDARD OPERATING PROCEDURES  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument  Collection and analysis of data by QUALIFIED PERSONS

19. QAC A quality policy A quality manual Control over all documents Quality atmosphere Well drafted ‘plan of action’

20. Major Components  Creation of QAC; QUALITY ASSURANCE UNIT  Appointment of a STUDY DIRECTOR  Need for written protocols; SOPs STANDARD OPERATING PROCEDURES  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument  Collection and analysis of data by QUALIFIED PERSONS

21. Study Director Responsible for the study Has control over everything May have a ‘Principal investigator’

22. Major Components  Creation of QAC; QUALITY ASSURANCE UNIT  Appointment of a STUDY DIRECTOR  Need for written protocols; SOPs STANDARD OPERATING PROCEDURES  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument  Collection and analysis of data by QUALIFIED PERSONS

23. A written procedure for doing everything SOP Work instruction Work procedure work protocol

24. Major Components  Creation of QAC; QUALITY ASSURANCE UNIT  Appointment of a STUDY DIRECTOR  Need for written protocols; SOPs STANDARD OPERATING PROCEDURES  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument  Collection and analysis of data by QUALIFIED PERSONS

25. Facility Equipment Environment Raw materials Maintenance

26. Major Components  Creation of QAC; QUALITY ASSURANCE UNIT  Appointment of a STUDY DIRECTOR  Need for written protocols; SOPs STANDARD OPERATING PROCEDURES  Necessity for using STANDARDISED, CALIBRATED and MAINTAINED equipment/instrument  Collection and analysis of data by QUALIFIED PERSONS

27. People problems Unscientific Untrained Unaware Unhelpful

28. GLP in action-I  Availability of written documents A place for everything and everything has a place Assessing quality of raw materials Maintenance of equipment Purchase of raw materials Authorisation to do receive, handle test materials Environmental monitoring Disposal of waste

29. GLP in action-II  Availability of written documents Entry restrictions Ensuring safety Authorisation to do receive, handle test materials Describing qualification/training requirements of staff Training of new personnel

30. GLP in action-III  Availability of written procedures/SOPs/protocols Receiving test materials Identifying (unique) samples Handling test materials Storing test materials Conducting each test Disposing materials Reporting results

31. GLP in action-IV  Documentation in approved formats Log book for equipment Data sheets for recording data Records of receipt, test procedures Approved report formats Compilation of data

32. GLP in action-V  Regular quality checks Auditing by qualified auditors Regular reporting of NCs and/or NICs Preventive and corrective actions

33. GLP in action-VI  Management commitment For ensuring high professional standards For up dating procedures according to changes in standards Participation in inter-laboratory comparisons Participation in proficiency testing

34. GLP in action-VII  Study Well defined study plan Well defined protocols Identification of critical stages Assured performance Reporting of deviations Compilation of data by qualified personnels Interpretation of data by professionals Archiving of materials/data/results

35. An auditors view What was the task? Why perform the task? Who performed the task? When was it done? How was it recorded?

36. Planned Study Quality Performance Rigorous Monitoring Unambiguous Records Study Director’s Report Archiving of materials Summary

37. Are we ready for GLP? We are ready, when we write what we do and when we do what we write, of course in compliance with national/international standards.