The Good Laboratory Practice Regulations 1999

1. Introductory Text

2. 1. Citation and commencement

3. 2. Interpretation

4. 3. The Good Laboratory Practice Monitoring Authority

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 of entry etc.

11. 10. Disclosure of confidential information

12. 11. Obstruction etc. of authorised persons

13. 12. False good laboratory practice instruments

14. 13. Offences by bodies corporate and Scottish partnerships

15. 14. Defence of due diligence

16. 15. Penalties

17. 16. Fees

18. 17. Revocation

19. Signature

20. SCHEDULES

    1. 1

       Principles of good laboratory practice

       1. Part I Test facility organisation and personnel

       2. Part II Quality assurance programme

       3. Part III Facilities

       4. Part IV Apparatus, materials and reagents

       5. Part V Test systems

       6. Part VI Test and reference items

       7. Part VII Standard operating procedures

       8. Part VIII Performance of the regulatory study

       9. Part IX Reporting of regulatory study results

       10. Part X Storage and retention of records and materials

    2. 2

       Inspection procedures and study audits

       1. Part I Inspections

       2. Part II Study audits

21. Explanatory Note