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:

  1. obtaining information on GMP requirements
  2. determining the appropriate quality system needed to control the design, production and distribution of the proposed device
  3. designing products and processes
  4. training employees
  5. acquiring adequate facilities
  6. purchasing and installing processing equipment
  7. drafting the device master record
  8. noting how to change the device master records
  9. procuring components and materials
  10. producing devices
  11. labeling devices
  12. evaluating finished devices
  13. packaging devices
  14. distributing devices
  15. processing complaints and analyzing service and repair data
  16. servicing devices
  17. auditing and correcting deficiencies in the quality system
  18. 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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