The Good Laboratory Practice Regulations 1997

1. Introductory Text

2. 1. Citation and commencement

3. 2. Interpretation

4. 3. Functions of the Secretary of State

5. 4. Requirement to be a member or a prospective member of the United Kingdom good laboratory practice compliance programme

6. 5. Prospective membership of the United Kingdom good laboratory practice compliance programme

7. 6. Membership of the United Kingdom good laboratory practice compliance programme

8. 7. Requirement to adhere to the principles of good laboratory practice

9. 8. Appeals against warning notices

10. 9. Powers and duties of inspectors

11. 10. Appointment of inspectors

12. 11. Disclosure of confidential information

13. 12. Obstruction etc. of inspectors

14. 13. Offences by bodies corporate and Scottish partnerships

15. 14. Defence of due diligence

16. 15. Penalties

17. 16. Fees

18. 17. Amendment of the Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993

19. 18. Amendment of the Notification of New Substances Regulations 1993

20. 19. Amendment of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994

21. Signature

22. 1. SCHEDULE 1

       PRINCIPLES OF GOOD LABORATORY PRACTICE (BASED ON ANNEX 2 TO THE DECISION OF 12TH MAY 1981 OF THE COUNCIL OF THE OECD ON THE MUTUAL ACCEPTANCE OF DATA FOR THE EVALUATION OF CHEMICAL PRODUCTS)

       1. PART I LABORATORY ORGANISATION AND PERSONNEL

          1. 1. The management’s responsibilities

          2. 2. The study director’s responsibilities

          3. 3. Personnel responsibilities

       2. PART II QUALITY ASSURANCE PROGRAMME

          1. 4. General

          2. 5. Responsibilities of the quality assurance personnel

       3. PART III FACILITIES

          1. 6. General

          2. 7. Test system facilities

          3. 8. Facilities for handling test and reference substances

          4. 9. Archive facilities

          5. 10. Waste disposal

       4. PART IV APPARATUS, MATERIALS AND REAGENTS

          1. 11. Apparatus

          2. 12. Materials

          3. 13. Reagents

       5. PART V TEST SYSTEMS

          1. 14. Physical/chemical

          2. 15. Biological

       6. PART VI TEST AND REFERENCE SUBSTANCES

          1. 16. Receipt, handling, sampling and storage

          2. 17. Characterisation

       7. PART VII STANDARD OPERATING PROCEDURES

          1. 18. General

          2. 19. Application

       8. PART VIII PERFORMANCE OF THE SAFETY STUDY

          1. 20. Study plan

          2. 21. Content of the study plan

          3. 22. Conduct of the safety study

       9. PART IX REPORTING OF SAFETY STUDY RESULTS

          1. 23. General

          2. 24. Content of the final report

       10. PART X STORAGE AND RETENTION OF RECORDS AND MATERIAL

           1. 25. Storage and retrieval

           2. 26. Retention

    2. SCHEDULE 2

       INSPECTION PROCEDURES AND STUDY AUDITS (BASED ON ANNEX B TO THE GLP INSPECTION AND VERIFICATION DIRECTIVE)

       1. PART I INSPECTION PROCEDURES

          1. 1. Pre-inspection

          2. 2. Starting conference

          3. 3. Organisation and personnel

          4. 4. Quality assurance programme

          5. 5. Facilities

          6. 6. Care, housing and containment of biological test systems

          7. 7. Apparatus, materials, reagents and specimens

          8. 8. Test systems

          9. 9. Physical and chemical systems

          10. 10. Biological test systems

          11. 11. Test and reference substances

          12. 12. Standard operating procedures

          13. 13. Performance of the study

          14. 14. Reporting of study results

          15. 15. Storage and retention of records

       2. PART II STUDY AUDITS

          1. 16. Laboratory inspections will generally include inter alia(limited) study audits. These...

          2. 17. In some cases, inspectors may need assistance from other experts...

          3. 18. When conducting a study audit, the inspector should— obtain names,...

          4. 19. In studies in which animals (i.e. rodents and other mammals)...

23. Explanatory Note