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GMP RegulationsGMP Regulations are issued by FDA under the Federal Food, Drug, and Cosmetic Act. The set out quality standards for the manufacture of products regulated by FDA, including pharmaceuticals, medical devices, biologic products including blood, food, and other specific products. GMP Regulations carry the force of law, and violating them can result in serious consequences including seizures, injunctions, and prosecution of those responsible. GMP Mastery™ embraces the philosophy that GMP Regulations provide a roadmap to mastering performance. Following the GMP regulations is NOT just a matter of compliance, but also of excellent performance.
Below are links to the GMP Regulations for several industries. Pharmaceutical Industry21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General (April 1, 2010) 21 CFR Part 211 -Current Good Manufacturing Practice For Finished Pharmaceuticals (April 1, 2010) Food Industry21 CFR Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (April 1, 2010) Blood Industry21 CFR Part 606 - Current Good Manufacturing Practice For Blood and Blood Components (April 1, 2010) Medical Device Industry21 CFR Part 820 - Quality System Regulation (April 1, 2010) Dietary Supplement Industry21 CFR Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations For Dietary Supplements (April 1, 2010) |
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