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GMP Booklet

Since 1962 Amendment, US Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP) which should be compliant to FDA 21 CFR Part 210-211

Since 1962 Amendment, US Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP) which should be compliant to FDA 21 CFR Part 210-211

GMP Booklet

by Quality and Invention
GMP Booklet
GMP Booklet
GMP Booklet

What is it about?

Since 1962 Amendment, US Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP) which should be compliant to FDA 21 CFR Part 210-211. The word "current" was later added to create CGMP to imply that the regulation allows/requires drug manufacturers to update technologies in attaining compliance. The updated GMP 210/211 regulations address current drug manufacturers’ operations including recordkeeping, personnel qualifications, cleanliness, equipment verification, process validation, and complaint handling, etc.

GMP Booklet

App Details

Version
2.0
Rating
NA
Size
1Mb
Genre
Books
Last updated
November 18, 2014
Release date
October 25, 2013
More info

App Screenshots

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App Store Description

Since 1962 Amendment, US Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP) which should be compliant to FDA 21 CFR Part 210-211. The word "current" was later added to create CGMP to imply that the regulation allows/requires drug manufacturers to update technologies in attaining compliance. The updated GMP 210/211 regulations address current drug manufacturers’ operations including recordkeeping, personnel qualifications, cleanliness, equipment verification, process validation, and complaint handling, etc.

The GMP Booklet App presents CGMP* in a user-friendly e-format. The users can easily reach to each section of CGMP regulation plus search function. This App is a convenient self-education and information tool for all people working in pharmaceutical and biotech industry.

*Note : Per the most current revision to the date of the app publication