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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