May 21, 2020
Supplement brands working with contract manufacturers need to have a hand in the game when it comes to following appropriate specifications and testing methods. Brand owners with an understanding of cGMPs (current good manufacturing practices) have a leg up in the supplement industry as they can help ensure best practices when working with their contract manufacturers.
This Q&A is a continuation of articles covering the ABH recall and COVID-19 threat to contract manufacturing relationships and Supplement brands and contract manufacturers: Healthy partnerships. Responses have been edited for clarity and space.
Q. Why must a brand owner understand cGMPs if all the manufacturing is conducted by the contract manufacturer?
Mike Finamore, CEO, Gemini: The cGMP (current good manufacturing practices) scope of responsibility required for the brand owner has been defined quite extensively by recent regulatory actions. In fact, the most critical responsibilities of the brand owner, i.e., to maintain specifications and have a process by which they release product to market, have been highlighted by lawsuits and government actions where the brand owner has not yet developed robust systems to handle these requirements.
Heather N.D. Fairman, DF Guardian Consulting Inc.: FDA requires by law (21 U.S. Code § 342) that an own-label distributor is ultimately responsible for ensuring the quality, safety and compliance of finished product, from its entire processing through release and distribution into commerce. “Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement cGMP requirements,” FDA has repeated in warning letters to finished product brands.
Abhishek K. Gurnani, partner, Amin Talati Wasserman: FDA on numerous occasions has voiced its opinion on this topic. Several cGMP requirements apply to an own-label distributor, even if it has absolutely no hand in the manufacture, storage or shipping of the product. For example, own-label distributors must establish specifications, institute written operating procedures that outline the responsibilities of its own quality department (an own-label distributor should have its own quality assurance [QA] department), document approval and release of products, and follow written procedures for complaints (including adverse event reporting) and employee training.
Eugene Ung, CEO, Best Formulations: When the GMPs were initially passed into law, brand owners assumed FDA would only be enforcing manufacturers. However, brand owners have just as much responsibility to public safety and following the regulations as the manufacturer. As a brand owner, understanding GMPs will help interpret audit results and understand where supply chain risks and opportunities may be.
Brandon M. Griffin, CEO, REJIMUS: Brand owners that either outsource everything (referred to as own-label marketers) or that conduct their own distribution (referred to as own-label distributors) have their own regulatory requirements to adhere to in order be GMP-compliant. Outsourcing the manufacturing does not eliminate regulatory obligations for brand owners, it just reduces them. Brand owners have an obligation to know the performance of the vendors and the compliance of the supply chain, whether that vendor is a manufacturer, distributor or a contract lab.
Blaž Gorjup, chairman and founder, PharmaLinea Ltd: If a brand owner understands what a development process looks like, what good practices are, why product stability is important and all the ways it can fail, then it will know the process can take a couple of months. The market demands complex formulations in complex delivery forms. Products that have been developed from the first concept to delivery in under six months could not have possibly gone through the right procedures to be able to claim quality and proven stability.
Q. How can brands ensure their contract manufacturers are setting and following the appropriate specifications and test methods?
Adel Villalobos, CEO and founder, Lief Labs: If the brand does not have technical know-how, it should hire a consultant and work with its contract manufacturer to become aware of how its product is made. Master manufacturing record (MMR) copies and specification customization documents should be agreed on and signed by both the brand and contract manufacturer. This is the start of a beautiful relationship where expectations are agreed upon from the beginning, frequency of testing is established and fees/costs are established to ensure the brand gets what it agreed to. Many times, brands and contract manufacturers do not have the important discussions early on.
Tara Lin Couch, Ph.D., senior director of dietary supplement and tobacco services, EAS Consulting Group LLC: Establishing scientifically sound and compliant specification is a critical part of any cGMP quality system that must be evaluated in thorough detail during the contract manufacturer qualification. Finished product specifications created by the contract manufacturer should also be reviewed, and preferably approved, by the own-label distributor prior to the manufacture of any products. In-process specifications are built into the MMR that should also be reviewed, and preferably approved by the own-label distributor prior to the manufacture of any products. Results demonstrating whether those in-process specifications were met will be provided in the batch production record (BPR), which are critical records that the own-label distributor should review.
Griffin: It is critical for brands to review the specifications of not only the finished product, but also of the respective ingredients that go into the product. Within the specifications should be the cited methods (not just analytical techniques). CoAs [certificate of analysis] created absent raw data are a general concern, so it’s essential for brands to access the laboratory operations or reports of the lab audit with supporting documentation of how each method was qualified. Not all methods are fit for purpose for a given sample matrix, so understanding the performance of the lab and methods is key.
Gurnani: Brands should be involved in setting specifications and reviewing the testing that shows the specifications have been met, especially if the brand is the formula owner. If specs are set by the contract manufacturer, brands should also have ready access to the specifications, and are required to review testing to document its approval and release for consumer use. We recommend a quality agreement that outlines each party’s obligations related to QC [quality control], including operations that obligate both parties, such as review and approval of specifications and test methods.
Mike Finamore, CEO, Gemini: Brand owners cannot operate in a vacuum. The best way for brand owners to confirm specifications are being followed is for the brand owner to understand the nature of the ingredients and the finished product. Once the brand owner understands the specifications and the complexity of the testing, along with the potential variabilities and considerations, they are a much stronger partner for the contact manufacturer. The brand owner will have the confidence that the product they are releasing to commerce meets requirements for their finished product.
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