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

References

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), http://ipecamericas.org/.

3. IPEC-Americas and IPEC Europe, Excipient Pedigree Position Paper (2009), http://ipecamericas.org/.

4. IPEC-Americas and IPEC Europe, Excipient Stability Program Guide (2010), http://ipecamericas.org/.

5. IPEC-Americas and IPEC Europe, Good Distribution Practices Guide (2006), http://ipecamericas.org/.

6. IPEC-Americas, Good Distribution Practices Audit Guide (2011), http://ipecamericas.org/.

7. IPEC-Americas, IPEC Europe, and the PQG, Good Manufacturing Practices Audit Guide (2007), http://ipecamericas.org/.

8. IPEC-Americas, IPEC Europe, and the PQG, Good Manufacturing Practices Guide (2006), http://ipecamericas.org/.

9. IPEC-Americas and IPEC Europe, Qualification of Excipients for Use in Pharmaceuticals (2008), http://ipecamericas.org/.

10. IPEC-Americas and IPEC Europe, Quality Agreement Guide and Template (2009), http://ipecamericas.org/.

11. IPEC-Americas, Significant Change Guide (2009), http://ipecamericas.org/.

12. IPEC, International Pharmaceutical Excipient Council Glossary (2010), http://ipecamericas.org/.

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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