What are Good Manufacturing Practices?
Good manufacturing practices or GMPs are manufacturing policies and procedures that help ensure the integrity, purity, strength and consistency of a dietary supplement product. The phrase is not limited to manufacturing activities. Private labelers, distributors and other companies that hold dietary supplements are also required to comply with US FDA good manufacturing practices.
What is Required for Good Manufacturing Practices?
The requirements for good manufacturing practices vary widely depending on the activities conducted at the particular facility. The following are some of the topics that must be addressed in a company's policies and procedures to ensure compliance:
- Personnel qualification & training
- Records retention
- Cleaning procedures
- Pest control
- Equipment controls
- Production process controls
- Warehousing and distribution controls
- Product complaints
- Returned products
- Reserve samples
- Component controls
- Document controls
- Recall procedures
- Disposal of non-conforming products
- Vendor controls
- Reportable Food Registry
- Cleaning of trucks for distribution
There are potentially more policies and procedures that may be required, but whether or not they are necessary is determined on a case by case basis and the potential hazards for each type of product.
Does your company need GMP?
FDA requires that anyone who manufactures, packages, labels, or holds a dietary supplement, including if you manufacture the supplement but someone else packages or labels the product and if you are the importer. This means that a private labeler would be required to comply with GMP regulations.
Do importers have to comply with FSVP?
The foreign supplier verification program or FSVP also applies to importers of dietary supplements. Dietary supplements are classified as foods under FDA regulations and all foods are subject to FSVP with some exceptions.