IPEC-Americas Chair Janeen Skutnik continued the call for more standards and regulation for the pharmaceutical excipients industry at yesterday’s IPEC Regulatory Conference afternoon session. “We’re not the Rodney Dangerfields of industry anymore,” she said, playing on the fact that many feel excipients are somehow a “lesser” part of the pharma industry because they’re “inactive” drug ingredients. “We need to work with Congress and regulators to put in place the right standards,” she said.
Former IPEC Chair Dave Schoneker also issued a call to action to industry members. He called on IPEC user companies to “qualify and audit all their suppliers” and to “stop making excuses” about why they can’t do so. “We’re IPEC global, we can’t wait for the regulators and the legislation—that will take years—and people are dying today. We’ve been talking about this [securing the supply chain] since 1995, and frankly, I’m tired of it,” he said.
Schoneker continued, aiming his directives at excipient suppliers. “Start marketing GMP,” he said. “Start getting audited and certified and sell based on your GMP expertise. Forget about using price as a main competitor—instead, prove to your customers why they should buy from you.”
FDA’s Edwin Rivera Martinez of CDER, also a speaker at the conference, didn’t take these calls from industry lightly. He agreed that there are great challenges in assuring integrity of the pharmaceutical supply chain and that manufacturers can’t rely on FDA for all their audits. FDA’s audits are infrequent he said and may not cover all the processes manufacturers need to look at for their specific products.
In terms of solutions, he said that FDA would like to see one national, electronic pedigree requirement to help secure the supply chain. He also noted that industry can take advantage of ICH Q7 and other available guidelines such as the GMP excipient guideline. Martinez’s colleague, Steven Wolfgang of the Office of Compliance at FDA, even pointed out that the agency can recognize certified third-party audits to help the industry through its growing global challenges.
Martinez did throw a bit of a scare to the audience though when he brought up show and shadow factories that put on a front of doing real manufacturing when they are actually buying product from other sites and reselling or repackaging the materials. FDA issued warning letters to two such facilities in China this past summer. Some red flags to watch for, he said, include discrepancies in date (e.g., compare when the materials arrived versus when production and testing were done) and if the facility happens to be “renovating” or “not manufacturing the day” you are there for your audit. You have to see the product being manufactured in action, he suggested. You can also ask to see batch records and other documentation as proof the factory is indeed operational.
Schoneker added that he discovered a shadow factory in England several years ago—so it’s important to recognize that these activities can occur anywhere.
Industry and regulatory presenters at the conference were in agreement that more needs to be done—and now—to help prevent future supply chain breaches. In fact, they seem to be getting closer and closer in thought about exactly how to do it. The next few months will be quite interesting to watch as consortia such as Rx-360 and certified auditing programs such as IPEA move forward—with regulatory acceptance likely following their efforts.