Key Documents

Regulation

GLP Statutory Instrument
www.hmso.gov.uk

OECD Revised GLPs (1997) - select monograph 45
www.oecd.org

Guidance

FDA Compliance Policy Guide Section 160.850. Enforcement Policy 21CFR11;Electronic Records;
Electronic Signatures CPG 7153.17
www.fda.gov

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring

• No.1 OECD Principles on Good Laboratory Practice
• No.2 Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice
• No.3 Revised Guidance for the Conduct of Laboratory Inspections and Study Audit
• No.4 Quality Assurance and GLP (revised 1999)
• No.5 Compliance of Laboratory Suppliers with GLP Principles (revised 1999)
• No.6 The Application of GLP Principles to Field Studies (revised 1999)
• No.7 The Application of the GLP Principles to Short Term Studies
• No.8 The Role and Responsibilities of the Study Director in GLP Studies
• No.9 Guidance for the Preparation of GLP Inspection Records
• No.10 The Application of the Principles of GLP to the Computerised Systems (1995)
• No.11 The Role and Responsibility of the Sponsor in the Application of the Principles of GLP
• No.12 Requesting and Carrying Out Inspections and Study Audits in Another Country
• No.13 The Application of the OECD Principles of GLP to the Organisation and Management of Multi-site Studies
• The Use of Laboratory Accreditation with reference to GLP Compliance Monitoring (1994)

All of the above can be found by visiting the OECD website:
www.oecd.org