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Current Good Manufacturing Practice (cGMP) – The difference between “Compliant” and “Certified”

Food quality and safety affects everyone.  The FDA regulates the quality of dietary supplements very carefully.  The main regulatory standard for ensuring quality and safety is the “Current Good Manufacturing Practice (cGMP)” standards defined by 21 CFR 111 (FDA code).  It requires sellers, suppliers, and manufacturers to comply with a number of standards including strong quality management systems, traceable product records, appropriate quality raw materials, robust operating procedures, product quality assurance and control, and reliable testing procedures.

While the FDA requires all manufacturers to register with the FDA, they are only able to periodically inspect facilities.  Even when they do inspect facilities, the FDA only cites cGMP violations needing corrective action.  They do not certify or decertify organizations.

In the nutraceutical industry, dietary supplement custom contract manufacturers are often asked if their facility is “cGMP certified”.  Here’s where it gets a little tricky and the customer needs to pay close attention.  Many manufacturers will respond that they are “cGMP compliant”.  This is not the same as being certified.  To be cGMP certified, a manufacturer must be compliant and also formally retain a 3rd party auditing firm to inspect their facilities and certify that the facilities are actively meeting or exceeding cGMP standards.  This audit is not cheap or quick.  It requires a high level of commitment by the contract manufacturer to pass this audit and be certified.

Claiming cGMP compliance means almost nothing because all dietary supplement manufacturing facilities in the United States must register with the FDA and be cGMP compliant.  When you are considering using a dietary supplement contract manufacturer, be sure to pay close attention to their cGMP claims.  Insist on cGMP certification and have them provide you with their audit certificate.  If they are reluctant or unable to do this, you should find a nutraceutical manufacturer that is able.

Sawgrass Nutra Labs is a cGMP certified nutraceutical contract manufacturer.  If you’d like more information, please contact us here.