CGMP Audits per 21 CFR Part 111 and 117
Audit of Firms own Manufacturing, Packaging and Testing Facilities
These audits allow for an independent assessment of the firms processes and procedures and provide an opportunity to learn quality systems being utilized by other firms.
Third Party Contract Manufacturers
If a firm outsources a Manufacturing and or Packaging process, the FDA holds the outsourcing firm responsible for CGMP compliance of the Contract Manufacturer.
Third Party Contract Laboratories
If a firm outsources raw material or finished product testing, the FDA holds the outsourcing firm responsible for CGMP compliance of the Third Party Laboratory.
Raw Material Suppliers
The CGMPs require all ingredients used in Dietary Supplements to be “qualified” by verifying the Certificate of Analysis (COA) is reliable and performing an on-site compliance audit.