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GMP standards evolve for supplement manufacturers

Supplement contract manufacturers are critical in the supplement industry as evidenced by the regulatory actions taken over the last decade. This decade of increased awareness for the element that best helps maintain a robust industry has dramatically changed the landscape. The implementation and enforcement of GMPs (good manufacturing practices) for dietary supplements is the impetus for this shifted landscape. That change continues even though what we are experiencing is a fermata relative to manufacturing scrutiny. This kind of pause in regulatory activity among contract manufacturers is temporary.

The first decade of de facto enforcement of the dietary supplement GMPs is complete. Contract manufacturers should not be getting warning letters detailing inadequate responses to inspectional observations regarding basic GMPs. Yet, warning letters continue to be issued to outlier companies that still cannot perform the basics.

Manufacturers that demonstrate quality and compliance in the industry must understand that the regulations detail “good manufacturing practices” not “perfect manufacturing practices.” While these regulations represent the minimum standard, they are not a complete definition of procedure, process or performance expected during daily operations. They are, however, subject to interpretation, and this is where the future lies.

While operation may run smoothly and fully comply with the regulations—based on past inspections and a lack of regulatory activity—more will be expected. Even without outstanding regulatory issues, contract manufacturers have opportunities for improvement or optimization. The status quo isn’t enough. FDA expects continuous quality improvement. The next rounds of inspections will delve deeper into the level of compliance outlined in GMP regulations, but also against FDA’s view and interpretation of them. Manufacturers can anticipate inquiries into how specifications are established and at what stage of manufacture are they applied. The next rounds of inspections will want to know how the identity of a dietary ingredient is affirmed through adequate testing. FDA will seek to understand the basis that a test method is scientifically valid. The next rounds of inspections will want to know more about the specifications for the identity, purity, strength and composition of the finished, packaged product. The devil will be in the details.

The common practice of exempting one or more specifications from testing at the finished product stage of manufacturing needs to be justified. That means controlled data and documentation. Details are needed on the identity of any blend of materials a contract manufacturer receives. Details are needed on the determination of critical control points exist within the manufacturing process.

Continual improvements in GMPs will be more closely evaluated in the laboratory area, if a contract manufacturer tests products itself or works with a contract lab. FDA will want to know how that laboratory is qualified, and the agency may note the location of the laboratory for follow-up.

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