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Good Manufacturing Practices

Good Manufacturing Practices (GMP) is a worldwide recognized document covering the control and management of manufacturing, and the quality control testing of pharmaceutical products. While there is no law that requires supplement companies to meet the stringent standards required of drug manufacturers, they should voluntarily subject their processes to FDA manufacturing practices. This scrutiny helps to assure the finest quality of products and build consumer confidence in a company.

Manufacturers should use sound discretion when developing their Quality Systems (QS); only applying those sections of the Quality System that are applicable to their specific products and operations. The GMP provides detailed guidance in the following areas:

obtaining information on GMP requirements
determining the appropriate quality system needed to control the design, production and distribution of the proposed device
designing products and processes
training employees
acquiring adequate facilities
purchasing and installing processing equipment
drafting the device master record
noting how to change the device master records
procuring components and materials
producing devices
labeling devices
evaluating finished devices
packaging devices
distributing devices
processing complaints and analyzing service and repair data
servicing devices
auditing and correcting deficiencies in the quality system
preparing for an FDA inspection.

In most cases, it is left to the manufacturer to determine the best methods to attain quality objectives.

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