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Key Documents

Regulation

FDA GLP Regulations for non-clinical laboratory [21 CFR: Part 58]
http://vm.cfsan.fda.gov

New GLP Statutory Instrument now in force
www.hmso.gov.uk

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

Online CFR (Searchable)
www.access.gpo.gov

Guidance

UK GLP MA Guide to UK GLP Regulations 1999
www.open.gov.uk/mca/mcahome

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