Live from ExcipientFest: Roundup of What’s Been Said

Here at ExcipientFest 2012, in connection with IPEC, rooms are full of attendees listening for ways to better follow GMPs, for best testing practices, for ways to manage user-supplier relationships and more. Below are a few key points made thus far.

-Relying on a Certificate of Analysis may not always guarantee what you are getting, Catherine Sheehan, USP

-The Chinese Pharmacopeia is adding 150 new monographs by 2015; some of these are being developed in coordination with USP

-Do excipient GMPs really exist? For starters, an excipient is a drug under the US Statute, and defined as a drug component. IPEC has the new ANSI NSF standard 363 on Excipient GMP.  And looking ahead, FDA is developing a proposed rule to amend regulations on the control over components used in the manufacture of finished products to increase assurance of shipments via quality specs, facility qualification, and controlled distribution. These sound like additional GMPs on the way…. Maridalia Torres, San Juan District Director, FDA

-There is a paradigm shift in industry to be proactive versus reactive, Maridalia Torres, San Juan District Director, FDA

-Where does FDA stand on third-party audits and auditors? The agency is still thinking this issue through but encourages and supports the industry efforts in this area. The agency may never put an official okay for third-party auditors on paper, so to speak, but the bottom line is that if a company uses a third-party auditor and can demonstrate that the organization and auditing process meet the end product’s quality specs and help in the process, then that is what FDA will be looking for. The responsibility is on the manufacturer to show that their choice and process in this area is quality and risk based.

-The upcoming PDUFA revision includes language about third-party auditors; it also addresses excipient manufacturer registration. Although individual excipient manufacturers do not have to register just yet, the final product manufacturer will need to list the names and addresses of its excipient manfuacturer suppliers/sources as part of their annual Section 510 registrations.