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A Practical Guide to Good Laboratory Practice (GLP) Quality Assurance

   

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Review of study procedures, documentation and reports by persons independent of the technical staff performing and managing studies, is a fundamental requirement of Good Laboratory Practice. UK GLP Regulations and the OECD Principles on which they are based, provide information on the requirements for Quality Assurance of studies in compliance with Good Laboratory Practice. These standards are further interpreted by the OECD document on Quality Assurance and GLP. Nevertheless, during moderation of the RQA GLP discussion forum in 2003-5, it became apparent to the RQA GLP Committee that there remain some areas requiring guidance as to best practice. In particular, it was the view of the committee that some relatively fundamental issues were ill-defined in GLP publications, perhaps because they are considered to be self-evident.

This document aims to provide helpful guidance with such issues, but should not be relied upon absolutely since it is not possible to consider and address the entire variety of situations arising in different countries, facilities, studies, and individual circumstances. In particular, it is emphasised that any illustrations provided in this guidance serve simply as examples of possibilities, and should not be taken as the only option. After reviewing the regulations, other support documentation and the advice herein, if it is considered that the particular circumstances warrant a novel approach, QA should have the courage to take the novel approach. As with any decision, it is strongly recommended that the decision and its justification be documented. 

Whilst this document is based on UK regulation and experience, it also addresses areas where QA input is useful, as well as those which are statutory requirements.

Since multi-site studies raise additional, specific issues for QA personnel, a separate section addressing this subject is appended.

Contents

  1. Introduction
  2. General
  3. How to Set up a QA Function
  4. QA SOPs
  5. QA Operations
  6. Study Plan Review
  7. Inspections
  8. Audit of Study Reports
  9. Reporting the QA Reports
  10. QA Statement
  11. QA Activities additional to those required by GLP Regulations
  12. QA Administration
  13. QA Training
  14. Appendix: Multi Site Studies
  15. References

Authors

The RQA GLP Committee

Price

Normal Price £10.00 

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ISBN

978-1-904610-07-6

Reprinted

December 2008



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