FDA is applying greater attention to and enforcement of dietary supplement regulations than ever before. This is not unexpected. The course of implementation of the regulations has come in waves of effort as inspections occurred after the finalization of GMPs (good manufacturing practices) for dietary supplements.
The application of the term “transparency,” when applied to the laboratory, whether, as part of a contract manufacturer or vertically integrated manufacturer or even just a brand owner involves two basic determinants. Looking at these from the standpoint of transparency is really a matter of knowing that the efforts are in line with the requirements of the regulations.
FDA is more commonly asking for this information during inspections with specific focus on testing and the qualification of said methods, as well as any reference materials. However, the root of it all is the establishment of specifications. The mandate for the establishment of specifications at each stage of manufacturing (component, in-process and finished product) is where it all begins. Knowing what specifications to establish includes evaluation of the labeled claims for the product and the ability to test using a qualified scientifically valid method; this is where the laboratory operations comes in.
Before a product can be tested in any lab, the lab has to know what it is looking for and how to test for it. Thus, the transparency between the lab and the client is essential to ensuring the absolute compliance of the brand owner. two critical elements from different parts of the regulations require absolute transparency in the other direction. Specifically, these critical elements are:
1. The determination that a specific test is appropriate for the application (fit for purpose)
2. Whether the method itself is scientifically valid and qualified by said lab.
The consideration of transparency when it comes to laboratory operations really begins before the testing itself, with the establishment of appropriate specifications to ensure the identity, purity, strength and composition of the dietary supplement product. Establishing a specification that cannot be measured is just as inappropriate at establishing a specification that does not truly accomplish the affirmation of the product regarding the parameters outlined.
Additionally, recognition of the label claims made on the product must be performed in order to meet this obligation. The testing then may be determined as specifically as possible to meet the expectations of FDA. This means using methods that have been evaluated for application in the specific instance applied and documentation of the efforts made to determine such qualification.
Merchants take advantage of our Free product compliance database. Reassure yourself and your customers that there is no illegal or bad ingredients in your products. HawkScanner allows you to confidently search for these ingredients and act fast.