GMP Booklet|書籍線上App不用買

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 with customized view options. This App is a convenient self-education and information tool for all people working in pharmaceutical and biotech industry.

Keywords : Keywords : GMP, CGMP, Good Manufacturing Practice, FDA 21 CFR Part 210-211, Regulation, Regulatory, Pharmaceutical, Biotechnology, book, reference

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

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