Conforming to the IPEC CoA Guide - Pharmaceutical Technology

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Conforming to the IPEC CoA Guide
Past IPEC-Americas excipient qualification committee chairs highlight changes to the IPEC guide on certificates of analysis for bulk excipients.

Pharmaceutical Technology
Volume 37, Issue 3, pp. 28-31


1. D. Schoneker, Changing the Supply-Chain Controls for Excipients –Part I: The IPEC-Americas Certificate of Analysis Guide for Bulk Pharmaceutical Excipients, Pharm.Tech. (June 2000).

2. IPEC-Americas, Excipient Master File Guide (2004),

3. IPEC-Americas and IPEC Europe, Excipient Pedigree Position Paper (2009),

4. IPEC-Americas and IPEC Europe, Excipient Stability Program Guide (2010),

5. IPEC-Americas and IPEC Europe, Good Distribution Practices Guide (2006),

6. IPEC-Americas, Good Distribution Practices Audit Guide (2011),

7. IPEC-Americas, IPEC Europe, and the PQG, Good Manufacturing Practices Audit Guide (2007),

8. IPEC-Americas, IPEC Europe, and the PQG, Good Manufacturing Practices Guide (2006),

9. IPEC-Americas and IPEC Europe, Qualification of Excipients for Use in Pharmaceuticals (2008),

10. IPEC-Americas and IPEC Europe, Quality Agreement Guide and Template (2009),

11. IPEC-Americas, Significant Change Guide (2009),

12. IPEC, International Pharmaceutical Excipient Council Glossary (2010),

13. A. Falk, PhD, Pharm.Tech. 34(3) (Mar. 2010).

14. B. Carlin et al., Pharm. Tech. 31 (9) (Sept. 2007).

15. PQG PS 9100:2002 Annex C Certificates of Analysis; WHO Technical Report Series, No. 902 & No. 908; UK Guidance on Certificates of Analysis (from Orange Guide).

16. Note: It is hoped that in the future, all excipient makers and excipient users will realize the benefits of establishing a long-term confidential disclosure agreement during the supplier qualification process.

17. USP, USP 35 General Notices, 5.40 Identity

18. 21 CFR 211.84(d)1

19. EU Legislation–Eudralex Vol 4: Good Manufacturing Practice Guidelines, Chapter 6 Quality Control, Annex 8 Sampling of Starting and Packaging Materials (2006).

Disclaimer: The views expressed in this article are those of the authors and do not necessarily reflect that of their employers.


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