Why GLP Certification Matters for Global Compliance (part 5)

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 Why GLP Certification Matters for Global Compliance (part 5);

Essential OECD Documents on Good Laboratory Practice (GLP): A Complete Reference

Published by VISNOVA Consultancy – Guiding You Through Global GLP Standards

For laboratories, regulators, and contract research organizations (CROs) involved in non-clinical health and environmental safety studies, the OECD Principles of Good Laboratory Practice (GLP) form the foundation of data credibility and international acceptance. To support consistent implementation and monitoring, the OECD has published a detailed series of guidance documents that clarify GLP principles and offer best practices across various aspects of laboratory operations.

In this blog, we provide an overview of the key OECD GLP documents every GLP-compliant test facility should be familiar with.

📘 OECD Series on Principles of GLP and Compliance Monitoring

Below is the official list of documents developed by the OECD Working Group on GLP, which are used by regulatory bodies and laboratories worldwide:

🔹 Core Principles & Inspection Guidelines

  1. OECD Principles of Good Laboratory Practice (Revised in 1997)

  2. Revised Guides for Compliance Monitoring Procedures for GLP (1995)

  3. Revised Guidance for the Conduct of Laboratory Inspections and Study Audits (1995)

  4. Quality Assurance and GLP (1999)

🔹 Application to Specific Practices & Systems

  1. Compliance of Laboratory Suppliers with GLP Principles (2000)

  2. Application of GLP to Field Studies (1999)

  3. Application of GLP to Short-Term Studies (1999)

  4. Role and Responsibilities of the Study Director in GLP Studies (1999)

  5. Guidance for the Preparation of GLP Inspection Reports (1995)

  6. Application of GLP Principles to Computerized Systems (1995)

  7. Role and Responsibilities of the Sponsor in GLP Studies (1998)

🔹 International Cooperation & Multi-Site Studies

  1. Requesting and Carrying Out Inspections and Study Audits in Another Country (2000)

  2. Application of GLP Principles to the Organization and Management of Multi-Site Studies (2002)

  3. Application of GLP Principles to In Vitro Studies (2004)

🔹 Infrastructure & Data Management

  1. Establishment and Control of Archives in Compliance with GLP (2007)

  2. Peer Review of Histopathology – GLP Guidance (2014)

  3. Application of GLP Principles to Computerized Systems – Advisory Document (2016)

  4. OECD Position Paper: GLP vs ISO/IEC 17025

🔹 Sponsor Influence, Test Items & Data Integrity

  1. Management, Characterization, and Use of Test Items

  2. Guidance for Receiving Authorities on Reviewing GLP Status of Non-Clinical Studies

  3. Position Paper on Sponsor Influence on GLP Conclusions

  4. Advisory Document on GLP Data Integrity

🌐 Where to Access These Documents?

All documents in this series are publicly available and can be downloaded from:

These resources are essential reading for QA personnel, GLP auditors, study directors, and laboratory managers aiming to maintain or achieve GLP certification.

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