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|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:
Please visit our Document Library for a
full list of helpful FDA documents as well as many others
from other regulatory agencies and industry groups.
The GMP Institute, a division of ISPE, has
more detailed explanation about GMPs that is very
During Drug Development
|The FDA considers
the GMPs to be a "sliding scale", meaning that
they must be more rigorously applied as products move
forward in development. In other words, during
manufacture of Phase I material less detailed
application of the regulations will be expected.
By the time a product reaches Phase III Clinical trials,
GMPs are expected to be fully followed during
"CGMPs that develop with clinical
studies, examples: process validation (e.g.
manufacturing, cleaning and sterilization), methods
validation, and process controls (e.g., in-process
testing and specifications)."