Designing a Testing Program for Dietary Supplements
What you need to know!
By Jeff Stassi - Eurofins Senior Analytical Service Manager - Dietary Supplements
Testing is a critical aspect of product development and quality. A well-designed testing program is critical to success to ensure that a product is safe, meets all of the specifications, and to ensure the quality of the labeled product. As you may know, the FDA has placed an emphasis on the manufacturing process with the advent of the dietary supplement GMPs back in 2007. In this regulation, there is an emphasis placed on ensuring quality from beginning to end considering identity, purity, strength and composition of the product and its ingredients. With that in mind, we will focus on the process and provide some insight in designing a meaningful, comprehensive testing program.
In any well-designed testing program, a focus should be placed on a few key areas:
- Ingredient qualification and safety
- In-process materials
- Finished product quality
Ingredient qualification and safety
The philosophy, as they say it, is garbage in means garbage out. With that in mind, the ingredients you use in the manufacturing of a dietary supplement must meet the quality specifications, especially as it relates to identity of the ingredient. You also cannot rely on the supplier COA as the sole means of qualifying the ingredient. There is no longer an avenue to test only the finished product and call that a robust test program.
Keep safety in the forefront (likely contaminants, microbiology) when designing specifications for ingredients, as you do not want to inadvertently enter an ingredient into the production line where it may not be safe.
In-Process materials
It is not always a certainty that if you put the ingredients together, a quality finished product is produced. Many variables come into play in the manufacturing process that may have an effect on the quality of the finished product. Therefore, it is wise to design specifications around those processes that are likely to cause change (i.e., mixing, heating, extracting) and to test the outcome of the process to assure it has not adversely affected the product quality.
Finished product quality
Probably the biggest focus on finished product quality is to ensure that the label claims are met and that the product placed in the market is safe. The FDA states that the dietary ingredient must meet 100% of the label claim throughout the shelf life of the product and must be free of contaminants that may pose a safety risk.
This is where many dietary supplement companies are cited for not having a robust testing program and do not verify the ingredient through testing. Scientifically valid test methods to measure components must be used, as this is also a focus for FDA auditors.
For more information on what a "scientifically valid" test method is read Jeff's blog article "What is 'scientifically valid'?".
Eurofins can help
Do you need help designing a testing program for your dietary supplements? Do you have a testing program but need to improve certain aspects of it? Contact us today to discuss your testing needs.