Gate2GMP® - Your free source for GMP and Quality Systems Compliance documents.

Continuously updated – easy to use – one source library for the Life Science industry

Document library

Speed up your search for regulatory texts and guidance documents related to International GMPs and Quality system regulations!

Document library

Warning letters

Search for Paragraphs cited in FDA Warning Letters:
21 CFR 211 (Pharma)
and
21 CFR 820 (Medical Device)

Warning letters

My Courses

Your Key2Compliance® course alumni point of reference.
All your course literature and references are easily accessed here.

My courses

Interpretations

Find the FDA interpretations for each paragraph in 21 CFR 210 and 211 (Pharmaceutical production). An invaluable tool to support disputes during and after a FDA inspection

Interpretations

Gate2GMP® Premium

GMP is much more than the paragraphs in the regulations. FDA continuously interprets the regulations and publish their positions in different documents. That’s why it’s called Current GMP. Sign up for Gate2GMP® Premium to add this to this unique search tool to your account.