Current Good Manufacturing Practices
Current Good Manufacturing Practices (cGMPs) represent the U.S. Food and Drug Administration's extensive requirements that over-the-counter and dietary supplement manufacturers must follow. This system of controls helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. cGMPs set standards for manufacturing and testing in the following areas: raw materials, quality assurance, record-keeping throughout the manufacturing process, standards for cleanliness and safety, qualifications of manufacturing personnel, product testing, production and process controls, and warehousing and distribution. CHPA member companies document how their specific processes meet cGMP standards. Adherence to cGMP regulations assures the identity, strength, quality, and purity of drug products.
On June 25, 2007, the U.S. Food and Drug Administration (FDA) released the final rule for dietary supplement Current Good Manufacturing Practices (cGMPs). This rule, which establishes uniform standards needed to ensure quality throughout the manufacturing, packaging, labeling, and holding of dietary supplement products, was implemented in 2008 for large companies and allowed for a three-year phase-in for smaller companies. Beginning in June 2010, all companies manufacturing, packaging, labeling, or holding dietary supplements were required to comply. This final rule requires that manufacturers verify the identity, purity, strength, and composition of their dietary supplement products. Dietary supplements containing contaminants or those not containing the dietary ingredient represented on the label would be considered adulterated or misbranded by FDA.
CHPA also participates in the Standardized Information on Dietary Ingredients (SIDI) Work Group, which has released three voluntary guidelines:
- The SIDI Protocol
- The Certificate of Analysis Guideline
- Dietary Supplement Component Supplier Qualification Guideline
These guidelines are intended to help the dietary supplement industry comply with cGMP regulations.