When starting a Holding and Distribution company, it’s easy to think that Good Manufacturing Practices (GMP) are the responsibility of the contract manufacturers or private label suppliers who produce dietary supplements. They are responsible, but that’s not quite the complete picture in the eyes of the FDA. SOPs and other records are required to stay compliant.
The FDA requires compliance with GMP in manufacturing, packaging, labeling, and holding operations for dietary supplements. That means the FDA expects that the distributor of the final product that reaches the consumer will also have responsibility for assuring the products they receive comply with all the GMP requirements. The holding and distribution companies ensure that packaging and labeling was done as specified in the master manufacturing record and ensures the quality of the product that reaches the market. Failure to comply means the FDA will consider these products to be adulterated.
When used in holding and distributing pharmaceutical or dietary supplement products, SOPs ensure that all products will meet their requirements for potency, purity, efficacy, safety and performance. They also ensure that drugs and supplements are designed and produced in accordance with cGMPs.
A full-fledged Quality System is made up of SOPs and Policies. Along with a full set of SOPs, InstantGMP also offers a package specific to distribution and holding companies.