Quality Assurance in Pharmaceutical Due Diligence eBooklet

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This booklet has been produced by RQA and SQA volunteers to provide detailed and practical guidance to those auditors involved in the due diligence process.

Contents

1. An Introduction to Due Diligence
2. General Due Diligence Considerations
3. Due Diligence Agreements
4. Specific GxP Sections
5. Post Due Diligence Activities
6. Acronyms/Glossary
7. Appendix 1 - Checklist (GLP Example)
8. Appendix 2 - Example of Due Dilignce Request for Information

Authors

RQA Due Diligence Working Party

ISBN

978-1-904610-28-1

Published

April 2013