The Good Laboratory Practice Regulations 1999

1 Citation and commencement

2Interpretation

3The Good Laboratory Practice Monitoring Authority

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

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

6Membership of the United Kingdom good laboratory practice compliance programme

7 Requirement to adhere to the principles of good laboratory practice

8 Appeals against warning notices

9Powers of entry etc.

10 Disclosure of confidential information

11Obstruction etc. of authorised persons

12 False good laboratory practice instruments

13 Offences by bodies corporate and Scottish partnerships

14 Defence of due diligence

SCHEDULE 1GOOD LABORATORY PRACTICE PRINCIPLES (BASED ON SECTION II OF ANNEX I TO THE EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 2004/10/EC)

PART ITEST FACILITY ORGANISATION AND PERSONNEL

1Facility management’s responsibilities

2Study director’s responsibilities

3Principal investigator’s responsibilities

4Study personnel’s responsibilities

PART IIQUALITY ASSURANCE PROGRAMME

2Responsibilities of the quality assurance personnel

PART IIIFACILITIES

2Test System Facilities

3Facilities for handling test and reference items

4Archive Facilities

5Waste Disposal

PART IVAPPARATUS, MATERIALS AND REAGENTS

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

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

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

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

PART VTEST SYSTEMS

1Physical/Chemical

PART VITEST AND REFERENCE ITEMS

1Receipt, handling, sampling and storage

2Characterisation

PART VIISTANDARD OPERATING PROCEDURES

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

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

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

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

PART VIIIPERFORMANCE OF THE REGULATORY STUDY

2Content of the Study Plan

3Conduct of the Regulatory study

PART IXREPORTING OF REGULATORY STUDY RESULTS

2Content of the Final Report

PART XSTORAGE AND RETENTION OF RECORDS AND MATERIALS

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

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

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

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

SCHEDULE 2REVISED GUIDANCE FOR THE CONDUCTOF TEST FACILITY INSPECTIONS AND STUDY AUDITS (BASED ON PART OF PART B OF ANNEX I TO THE EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 2004/9/EC)

PART IINSPECTION PROCEDURES

1Pre-inspection

2Starting conference

3Organisation and personnel

4Quality assurance programme

6Care, housing and containment of biological test systems

7Apparatus, materials, reagents and specimens

9Test and reference items

10Standard operating procedures

11Performance of the study

12Reporting of study results

13Storage and retention of records

PART IISTUDY AUDITS

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

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

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

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

1999 No. 3106

HEALTH AND SAFETY

The Good Laboratory Practice Regulations 1999

Made18th November 1999

Laid before Parliament19th November 1999

Coming into force14th December 1999

The Secretary of State, being a Minister designatedM1 for the purposes of section 2(2) of the European Communities Act 1972M2 in relation to measures relating to good laboratory practice, in exercise of the powers conferred by the said section 2(2)M3, and of all other powers enabling him in that behalf, hereby makes the following Regulations—