What is in this article?:
- GMP compliance is responsibility of both marketers, contract manufacturers
- Get to know your contract manufacturer
Marketers and distributors of dietary supplements must assume responsibility for GMP compliance with their products even if they are made by a contract manufacturer. FDA inspectors will expect a private-label supplement company to have all the documentation on hand to prove that their products are made in a way that complies with the law.
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Working with a contract manufacturer can lower barriers to entry to the dietary supplements business. It can help shave product development times and can allow someone who is gifted at, say, formulation or marketing to do what they’re good at while leaving the capsule-filling to someone else.
But you can’t shift the quality assurance responsibility with the relocation of the physical manufacturing. What’s in and on the bottle is your responsibility, not just the contract manufacturer’s.
This point was emphasized by Marc Ullman and Marc LeDoux in an education session at the Supply Side West show in Las Vegas on Tuesday on working with contract manufacturers in light of GMP compliance.
Ullman, a partner in Ullman, Shapiro & Ullman LLC and LeDoux, founder and CEO of Natural Alternatives, Inc. based their presentation in part on the text of two recent warning letters from FDA to dietary supplement private label companies that were doing business with contract manufacturers. Language repeated word-for-word in the text of both letters made it clear that FDA considers a marketer or distributor of a dietary supplement to be the manufacturer of the product as far as the responsibility for GMP compliance goes.
FDA expects a private label company to have on hand the master manufacturing records for their product, the batch records, the records of what tests were performed on ingredients and when, etc. Essentially, a private label distributor (as well as the contract manufacturer) is charged with having on hand the full suite of documents required to demonstrate GMP compliance. According to the doctrine set out in these warning letters, it won’t fly with an FDA inspector to say that all that is the contract manufacturer’s responsibility.