September 24, 2019
“Continuous improvement is better than delayed perfection.”—Mark Twain
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.
This temporary pause in the intensity of regulatory scrutiny of manufacturers is not an achievement by any segment of the industry. FDA is likely re-grouping and organizing its agenda for upcoming inspections.
FDA considers GMPs the minimum standards. This is among the reasons why the regulations have the flexibility that allows manufacturers to adapt operations to the law without mandating specific processes. At the same time, it affords FDA the opportunity to define expectations during inspections. This results in the deeper dives that will occur in the future. Consider, for example, the issue no longer being whether ingredient specifications are established, but rather FDA will want justification for a given specification. Consider the issue no longer the existence of established specifications for a finished product, but rather whether exemptions from testing for a reduced testing scheme have proper documentation. Compliance details and continual improvements will be sought during FDA’s next rounds of GMP inspections.
Manufacturers cannot meet GMP fundamentals and then graduate to the next level. Neither must manufacturers perfectly apply the regulations.
As chief operating officer, Jim Lassiter oversees all consulting operations at REJIMUS, formerly Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.
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