July 13, 2022
With modern priorities for natural products brands spanning responsibly sourced ingredients to clean labels, partnering with a contract manufacturer that understands a company’s specific needs is essential. Industry experts shared insights on the types of questions to use in the vetting process.
Bruce Kneller—principal and executive for operations, regulatory and legal affairs at KLZ Holdings LLC—offered a host of “must ask” questions. These include:
• Does the contract manufacturer have standard operating procedure (SOPs)? When can I review them?
• Has the contract manufacturer ever been inspected by FDA or any other state/federal agency? What was the result of these inspections? Likewise, have they ever received a warning letter?
• Has the contract manufacturer ever done a recall? If so, it’s important to see the whole process to make sure it was handled correctly.
• Has the contract manufacturer ever been party to a lawsuit as a defendant and it (or its insurance company) had to pay out a settlement? Online databases like PACER (public access to court electronic records) can provide this information, but it’s good to see if the contract manufacturer is upfront and honest about it.
• Ask to see validation plans and actual validations for all ingredients the contract manufacturer allows into the building for any reason. This includes machinery and packaging validation used in production.
• Does the contract manufacturer do any on-site laboratory testing? If so, ask to see adherence to cGLPs (current good laboratory practices) in addition to cGMPs (current good manufacturing practices).
• Has the contract manufacturer ever had to write a specification deviation to release a product?
• Ask to see audit results from any vendors that are used to source ingredients, machinery, etc. Also, ask to see training documents and job descriptions for all staff and employees.
• If the contract manufacturer imports its ingredients, edible or otherwise, check that it is importing things legally and correctly. Look for a paper trail showing HTS (harmonized tariff schedule) codes, requests from CBP (U.S. Customs and Border Protection)/HIS (Homeland Security Investigations), etc.
James Tonkin, founder and president emeritus of Healthy Brand Builders, added that it’s key to develop a point of contact through which all correspondence is directed. “This will be important throughout the contract period. Then have the results of their capabilities and availabilities in writing in your dossier files.”
Also a requisite in Tonkin’s book? “Confirm [the contract manufacturer’s] ability to produce your brand to your specs, not theirs. Always get a CoA [(certificate of analysis)] on all ingredients used during the manufacturing of your brand, and make sure your [contract manufacturer] does a supply chain verification of all products used,” he said. Additionally, Tonkin recommended confirming pricing on all facets of the brand’s needs before proceeding into production.
To continue reading this article, as well as related content, visit the digital magazine, “Cooperation and compliance in contract manufacturing.”
Content writing and journalism are high on the list of Joy Choquette’s interests. Writing professionally for the past 12 years, her work has appeared in national magazines, regional newspapers, and on lots and lots of websites. She specializes in health and wellness, business, and environmental topics. Learn more by visiting her website or find her on LinkedIn.
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