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 pharmaceuticals and dietary supplements. They are responsible, but that’s not quite the complete picture in the eyes of the FDA.

The FDA requires compliance with GMPS in manufacturing, packaging, labeling, and holding operations for dietary supplements and pharmaceuticals. 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 company has to ensure that packaging and labeling was done as specified in the master manufacturing record, and ensure the quality of the product that reaches the market. Failure to comply means the FDA will consider these products to be adulterated.

Fortunately, InstantGMP^™ provides a set of Policies and Standard Operating Procedures that provide a roadmap to compliance for Holding/Distribution Companies. When used in holding and distributing pharmaceutical or dietary supplement products, they ensure that all products will meet their requirements for potency, purity, efficacy, safety, and performance. They also guarantee that drugs and supplements are designed and produced in accordance with cGMPs. Fill out the form or contact us to learn more!

InstantGMP recommends the set shown below for Holding and Distribution companies:

STANDARD OPERATING PROCEDURES

To contact us, use this form or email us at info@instantgmp.com