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Q.

What is the meaning of gmp

About: Gmp

29 Jun '09 12:36 pm
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Answers (2)

1.

Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food
Answered by SHASHI AGRAWAL, 29 Jun '09 12:39 pm

 
  
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2.

Guaranteed maximum price (GMP)
Definition
Amount beyond which a client (project owner) is not obligated to compensate the contractor.

CGMP are the Current Good Manufacturing Practices followed by the pharmaceutical and biotech firms to ensure that the products produced meet specific requirements for identity, strength, quality, and purity. FDA regulates these industries to ensure CGMPs are being followed by using the following tools:

CGMP regulations: Laws which can incur criminal penalties when they are not followed; for example: 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs; General Part
21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 600 - Biological Products: General
21 CFR Part 11 - Electronic Records; Electronic Signatures ...more
Answered by gsuryanarayana, 29 Jun '09 12:38 pm

 
  
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