By Mark Land, AAHP President
This month, we're kicking off a series of articles on supply chain management. Penned by Tim Clarot, who spent 20 years managing a virtual supply chain for one of the most popular homeopathic brands, these articles will be both insightful and instructional. We also hear from George Bernstein, PhD., whose article promotes the benefits of hiring an experienced Quality Assurance Manager. George touches on the need to authenticate a high dilution of Arsenicum received as a homeopathic API. How can you do that to the satisfaction of FDA?
What is emerging from AAHP’s series of Summits and comments from FDA is that a detailed and documented control of the supply chain, back to when the API was tested for identity, is probably the best we can do at this point in time. With that in mind, Tim’s series of articles is timely, and George’s advice to hire an experienced QA manager makes sense.
With the globalization of the supply chain beginning more than 20 years ago, FDA has long encouraged drug manufacturers to “know their suppliers.” Knowing your supplier means more than verifying their certificate of analysis results. It means building robust programs that ensure that your quality team is fully aware of manufacturing, quality control, and change control processes at the third-party site in a first-hand way.
Optimum communications, quality agreements, and certificates of analysis are not enough to minimize the risk of gradual departure from expectations—and that risk increases with the complexity of the business. There is no substitute for in-person, eyes-on contact with your suppliers. If your own personnel can’t be there in person, hire a third-party auditor. However, auditing is only effective if the auditor knows what to focus on. Be sure to develop the audit plan with the third party prior to the visit.
In the environment that requires us to document the supply chain for APIs back to when it was tested in compliance with 21 CFR 211.84 (d)(2), it is imperative to possess documented evidence that the API received has a traceable and reliable pedigree back to a starting material and or a low homeopathic dilution.
Tim’s supply chain series is a great look into those tools and tactics that can strengthen your supply chain. Even so, someone must drive the quality of APIs and final products. That is where George’s Quality Assurance manager comes in.
AAHP and HPUS will host a GMP seminar on Nov. 10, presented by EAS Consulting. The speakers are former FDA officials with deep insight into supplier relations, among other GMP topics. Email invitations to the seminar are likely to be in your inbox now. Please consider joining us on Wednesday, Nov. 10.