The FDA wants to shut down Kabco Pharmaceuticals and prevent them from producing dietary supplements until they comply with GMP requirements. (See FDA News Release for more details). The FDA alleges that the company has made dietary supplements that do not meet GMPs. One issue in particular is that distributed supplements did not meet product specifications.
Product specifications are important for controlling the quality and safety of any product that is produced for human use. Specifications include the tests that assure the product contained what it was supposed to have in it and there was nothing that would have adulterated the finished product. InstantGMP understands how to prevent issues from arising and uses very thorough quality processes checks built into the software to make sure every dietary ingredient, component and material used in production is controlled and safe.
The specification process begins by assigning each dietary supplement or active ingredient, each excipient, each manufacturing component and each label a separate, traceable part number that is associated with the material as it moves through the production process. Materials are further controlled by preventing any material from being ordered or used until there is a confirmed, approved supplier and approved specifications. Specifications have a variety of attributes associated with them that will help manufacturers control the quality of their incoming materials and their final products. Specifications in InstantGMP include:
- Safety and handling instructions for manufacturing personnel
- Sampling instructions for QC personnel
- The tests to be performed
- The methods required for each test
- Acceptance limits for each test
Why are specifications important? Specifications are the way manufactures can consistently assure that each material that is received at the manufacturing site is what is supposed to be and that it is not contaminated. Without specifications and adherence to specifications, there is the potential that a product will get something into it that is not supposed to be there. Specifications and testing of dietary ingredients and other components for dietary supplements are especially important since the FDA does not require full release testing of each ingredient in the final dietary supplement product. The only sure way to produce a pure and high quality dietary product is to control each incoming material and that is done with a thorough specifications program.