“Big companies like Pfizer buy lots of excipients and typically conduct one audit of one plant maybe every two years and in between they rely on quality agreements to fill in the gaps,” Britta Lichtenhan, excipient qualification committee chair at IPEC, told In-Pharmatechnologist.com.
More recently, however, companies using the excipients saw reports of Chinese “gutter oil” used in some manufacturing processes and questioned their suppliers’ practices. Excipient manufacturers are still receiving questions from their customers on the use of the Jatropha plant as well, which the FDA said could contain toxins if products are derived from it, Lichtenhan said.
In order to ease the burden of questioning on excipient manufacturers, IPEC recently updated its excipient information package user guide to offer standard questionnaires for excipient makers to reveal their raw-material sourcing and other information needed to answer quality questions, Lichtenhan said.
“The idea behind this and what IPEC would like to see is users and suppliers exchanging excipient information through the standard form to get past the idea that a drugmaker needs to send surveys to a supplier for every little issue,” she noted.
The guide, which can be downloaded from the IPEC website for free, defines the standard excipient package information, which is comprised of:
- A product regulatory datasheet to assist in communicating to the user important physical, manufacturing and regulatory information specific to the excipient;
- Site quality overview to assist in evaluating the manufacturing practices and quality systems of suppliers, as well as to assure appropriate GMP requirements; and
- Site and supply chain security overview to provide to provide users with information concerning the supplier's plans to ensure the protection of the product and the continuity of supply.
FDA Regulation of Excipients?
But as users express worry about excipient contamination and require more questionnaires of its suppliers, the FDA does not have any plans to begin inspecting excipient supplier facilities, Lichtenhan said.
Under title VII of the new FDASIA (Food and Drug Administration Safety and Innovation Act) legislation, the FDA will require excipient manufacturers to use a unique facility identifier that includes an email and contact information for a supplier’s contact employee.
“The FDA has yet to put a process in place for this” and to allow for more supply chain transparency, she added. However, she did say she believes the agency is moving in the direction of conducting audits of excipient manufacturers in the future.