US GMP Resources

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GMP Regulations and Historical Preambles

Drugs

21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs - (As of 1 April 2011) [PDF ( 214 KB)]  
21 CFR Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals- (As of 1 April 2011) [PDF ( 239 KB)] 
Historical preambles announcing changes and comments regarding 21 CFR Parts 210 and 211 .

Food 

21CFR Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food  (As of 1 April 2011) [PDF ( 214 KB)] 
Historical preambles announcing changes and comments regarding 21 CFR Part 110.

Blood and Blood Components

21 CFR Part 606 - Current Good Manufacturing Practice For Blood and Blood Components (As of 1 April 2011) [PDF ( 222 KB)] 
Historical preambles announcing changes and comments regarding 21 CFR Part 606

Medical Devices

21 CFR Part 820 - Quality System Regulation (As of 1 April 2011) [PDF ( 220 KB)] 
Historical preambles announcing changes and comments regarding 21 CFR Part 820

Dietary Supplements

21 CFR Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary 

GMP Guidelines

Other Resources


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Last Update: 19 September 2011

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