This document is meant to serve as a guide for the preparation and appropriate use of a Certificate of Analysis (COA) for pharmaceutical excipients. The goal, according to IPEC, “is to standardize the content and suggest a format for COAs for excipients, and to clearly define the roles and responsibilities for the excipient manufacturer and distributor. The detailed definitions and discussions are intended to establish a uniform approach. By providing this foundation for mutual understanding, the COA will serve as an important element of the overall supply chain controls needed to provide the user with assurance of excipient conformance to specification and its suitability for use in pharmaceuticals.”
The example COA is a great tool for companies to use as a model for their internal use and in negotiating requirements with their suppliers on what should be contained in the certificate of analysis. Too many times, we see inadequacies in the COAs provided by excipient manufacturers. The recommendation to include both the supplier and the manufacturer ensures better traceability of the supply chain.