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GMP compliance is responsibility of both marketers, contract manufacturers

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.

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.


Get to know your contract manufacturer

Ullman and LeDoux emphasized that visiting a contract manufacturer and getting to know them and their operation is absolutely critical when deciding whether to work with a given company.  Is the facility clean and up to standard? Can you visit your contract manufacturer on short notice, or do they require long advance warning of a visit from one of their customers?

And asking the questions an FDA inspector might ask is part of the deal, too. What kind of procedures are in place to verify that the stuff going into the product is what you think it is? The GMP requirements are a number of years old now and still companies are still  being cited for inadequate identity testing (or not doing any ID testing at all). Too many companies continue to rely on certificates of analysis (COAs) sent along by the ingredient supplier.

“That doesn’t work any more and FDA is getting very tired of hearing this from our industry,” Ullman said.

A private label company should also have retained samples on hand, LeDoux said.  The samples have to be in the exact packaging of the original product and should be retained for at least one year after the stated expiration date or two years after the last batch sells out.  LeDoux suggested keeping retained samples longer, saying his company has some that are twenty years old. Ullman said it’s a cheap form of insurance; without a number retained samples, there is no way to refute a claim of contamination via independent testing of a sample. 

Ullman and LeDoux detailed a number of other GMP deficiencies noted by  FDA, including not keeping records of how products were stored during the distribution process.  The bottom line, though, was this:  You can contract out the actual making of the stuff.  But the responsibility for making sure it is what the label says it is, that it’s safe and not depleted or spoiled, is yours.

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