A Practical Guide to GLP Quality Assurance eBooklet

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UK GLP Regulations and OECD GLP Principles define the responsibilities of Quality Assurance. These standards are further interpreted by the OECD document on QA 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.

Contents

1. Introduction
2. General
3. How to Set Up a Quality Assurance Function
4. Quality Assurance Standard Operating Procedures
5. Quality Assurance Operations
6. Study Plan Review
7. Inspections
8. Audit of Study Reports
9. Reporting the Quality Assurance Findings
10. Quality Assurance Statement
11. Quality Assurance Activities Additional to Those Required by GLP Regulations
12. Quality Assurance Administration
13. Quality Assurance Training
14. Appendix: Multi-site Studies
15. References

ISBN

978-1-904410-24-3

Published

April 2013