IPEC_Europe_GDP_Audit_Guide__-_Revision_2011_final教材.pdfVIP

The IPEC - Europe Good Distribution Practices Audit Guideline FOR PHARMACEUTICAL EXCIPIENTS 2011 Copyright © 2011 The International Pharmaceutical Excipients Council - Europe IPEC Europe Good Distribution Practices Audit Guideline for Pharmaceutical Excipients This document has been written to provide a tool for those auditing companies involved in the supply chain of pharmaceutical excipients. This Audit Guideline should be used in conjunction with the IPEC Good Distribution Practices Guide. The explanatory notes in this guideline are provided to help the auditor obtain the maximum benefit in its application. This document is a revised version of the IPEC Good Distribution Practice Audit Guideline for Pharmaceutical Excipients 2008 [1]. Table of contents Page I. Introductory Note 2 II. Scope 2 III. Pharmaceutical Grade Excipients 2 IV. Acknowledgements 3 1. Quality Management 4 2. Organisation and Personnel 6 3. Premises8 4. Warehousing and Storage 10 5. Equipment 14 6. Documentation 17 7. Repackaging and re-labelling 20 8. Complaints25 9. Recalls 26 10. Returned Goods26 11. Handling of non-conforming materials 27 12. Dispatch and Transport 27 13. Contract Activities29 Appendix Bibliography 31 Copyright © 2011 The International Pharmaceutical Excipients Council - Europe Page 1 I. Introductory Note The International Pharmaceutical Excipients Council (IPEC) first published a GMP Audit Guideline for Distributors of Bulk Pharmaceutical Excipients in 2000. This document was designed as a questionnaire to assi