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.
Mar 02, 2013

Juanita Garofalo
More than a decade has elapsed since the IPEC-Americas Certificate of Analysis Guide for Bulk Pharmaceutical Excipients (CoA Guide 2000) was published (1). Since then, important changes in the global pharmaceutical industry and regulatory arena have occurred, which have necessitated development of the IPEC Certificate of Analysis Guide for Pharmaceutical Excipients, 2013 (CoA Guide). Among those changes are the formation of the IPEC Federation in 2010, publication of interrelated IPEC documents (2-12) that reference excipient certificates of analysis, increased emphasis on supply chain transparency (13) to protect the lives of patients, and the availability of Product Quality Research Institute (PQRI)-defined options to finished excipient testing (14). The CoA Guide incorporates current best practices from industry and regulatory sources (15).

David B. Klug
The IPEC Federation was established to better coordinate the work of IPEC-Americas, IPEC Europe, IPEC Japan, and IPEC China toward meeting the objectives of their member companies and the industry as a whole. Patient safety is a key driver of all IPEC guides. Because many pharmaceutical excipients now are manufactured, distributed, and used globally, the CoA Guide was bilaterally developed by IPECAmericas and IPEC Europe. In addition, the CoA Guide will be provided to IPEC Japan and IPEC China for possible adoption and publication in their respective regions. Because the excipient trade is international, the CoA Guide will be an invaluable asset to the worldwide industry.

David R. Schoneker
The CoA Guide was developed as a collaborative effort by excipient makers, distributors, and users. Members of the IPEC-Americas Excipient Qualification and the IPEC Europe Quality/Regulatory Affairs committees comprised the working group that developed the CoA Guide. IPEC member company issues were identified and addressed in the revision process, such as: absence of analytical method reference, computer software constraints, circumstances when the excipient manufacturer does not need to perform identification tests, legibility, absence of name and address of the original manufacturer, supply chain transparency, and use of terms other than expiration date or recommended re-evaluation date. In addition to IPEC member-company input, FDA has presented their thoughts on CoAs at various conferences and in meetings with IPECAmericas, and FDA's comments were also addressed during the revision process.

International excipient GMP certification standards include requirements that are consistent with the CoA Guide. The NSF/IPEC 363 GMP for Pharmaceutical Excipients standard (currently under development) defines the minimum required CoA content. Also EXCiPACT Certification Standards for Pharmaceutical Excipients: Good Manufacturing Practices/Good Distribution Practices includes various CoA-related requirements.

The CoA Guide will be provided to the United States Pharmacopeia (USP) for their consideration in revising General Chapter <1080> Bulk Pharmaceutical Excipients—Certificate of Analysis, which is currently based on the CoA Guide 2000. Regulatory agencies and industry organizations such as Sindusfarma in Brazil and SaFyBi in Argentina also will be provided with the CoA Guide as part of an ongoing effort to harmonize excipient expectations worldwide.