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GMP Certification

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

Benefits of GMP Certification

  • Increases the creditability and offers a competitive advantage in the marketplace for contract manufacturers
  • Increases senior management confidence in the preparedness of manufacturing facilities for inspection
  • Decreases the time and cost for companies selecting third-party testing and product certification if using GMP registered contract manufacturer; which is a national program that is designed to provide a system of processes, procedures, and documentation to ensure that the product produced has the identity, strength, composition, quality, and purity that it is represented to possess
  • Manufacturers of dietary supplements that comply with GMP requirements receive certificates and are listed on the NSF website
  • Available to all manufacturers of dietary supplements.

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