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The Good Laboratory Practice Regulations 1999

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  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

    1. SCHEDULE 1

      GOOD LABORATORY PRACTICE PRINCIPLES(BASED ON SECTION II OF THE ANNEX TO COUNCIL DIRECTIVE 87/18/EEC,AS AMENDED BY COMMISSION DIRECTIVE 1999/11/EC)

      1. PART I TEST FACILITY ORGANISATION AND PERSONNEL

        1. 1. Facility management’s responsibilities

        2. 2. Study director’s responsibilities

        3. 3. Principal investigator’s responsibilities

        4. 4. Study personnel’s responsibilities

      2. PART II QUALITY ASSURANCE PROGRAMME

        1. 1. General

        2. 2. Responsibilities of the quality assurance personnel

      3. PART III FACILITIES

        1. 1. General

        2. 2. Test System Facilities

        3. 3. Facilities for handling test and reference items

        4. 4. Archive Facilities

        5. 5. Waste Disposal

      4. PART IV APPARATUS, MATERIALS AND REAGENTS

        1. 1.Apparatus, including validated computerised systems, used for the generation, storage...

        2. 2.Apparatus used in a regulatory study should be periodically inspected,...

        3. 3.Apparatus and materials used in studies should not interfere adversely...

        4. 4.Chemicals, reagents and solutions should be labelled to indicate identity...

      5. PART V TEST SYSTEMS

        1. 1. Physical/Chemical

        2. 2. Biological

      6. PART VI TEST AND REFERENCE ITEMS

        1. 1. Receipt, handling, sampling and storage

        2. 2. Characterisation

      7. PART VII STANDARD OPERATING PROCEDURES

        1. 1.A test facility should have written standard operating procedures approved...

        2. 2.Each separate test facility unit or area should have immediately...

        3. 3.Deviations from standard operating procedures related to the regulatory study...

        4. 4.Standard operating procedures should be available for, but not be...

      8. PART VIII PERFORMANCE OF THE REGULATORY STUDY

        1. 1. Study plan

        2. 2. Content of the Study Plan

        3. 3. Conduct of the Regulatory study

      9. PART IX REPORTING OF REGULATORY STUDY RESULTS

        1. 1. General

        2. 2. Content of the Final Report

      10. PART X STORAGE AND RETENTION OF RECORDS AND MATERIALS

        1. 1.(1) The following should be retained in the archives for...

        2. 2.Material retained in the archives should be indexed so as...

        3. 3.Only personnel authorised by management should have access to the...

        4. 4.If a test facility or an archive contracting facility goes...

    2. SCHEDULE 2

      REVISED GUIDANCE FOR THE CONDUCTOF TEST FACILITY INSPECTIONS AND STUDY AUDITS(BASED ON PART OF PART B OF THE ANNEX TOCOUNCIL DIRECTIVE 88/320/EEC, AS AMENDED BYCOMMISSION DIRECTIVE 1999/12/EC)

      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. Test and reference items

        10. 10. Standard operating procedures

        11. 11. Performance of the study

        12. 12. Reporting of study results

        13. 13. Storage and retention of records

      2. PART II STUDY AUDITS

        1. 1.Test facility inspections will generally include, inter alia, study audits,...

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

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

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

  20. Explanatory Note

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