Dietary supplement companies often depend on contract manufacturers to produce some or even all of their products.
This has long been an effective business strategy for entrepreneurs and firms whose core talents are marketing, formulation, or distribution.
Under the current GMP regulations marketers can no longer shift the burden for product QA to their manufacturers
Every company must control the quality of their own labeled products.
Every company must verify that their vendors operate in a continuous "state of control", and that their products are produced, held, and distributed in a manner that prevents contamination and adulteration.
If your company uses contract manufacturers you need to:
- Get to know your suppliers before you start working with them. Are they complying with cGMP regulations already? Based on what evidence?
- In addition to a standard business contract, you need to negotiate and implement a Supplier QA Agreement with every supplier.
- Visit your supplier's manufacturing locations. Ask questions an FDA inspector would ask. Audit their facility, training, records, sample retention and testing practices, the works. Make sure you can live with the answers. In the event of an FDA inspection you will have to.
If you find that you'd like some help with your vendor qualification effort, please contact us.