Glossary

GMP Facility

February 27, 2012

A production facility or clinical trial materials pilot plant for manufacturing drug products or APIs. It includes the manufacturing space, the storage warehouse for raw and finished product, and support lab areas, as well as laboratories that are independent of production facilities. A GMP facility operates under the guidelines established by the CFR (Code of Federal Regulations) Title 21, Parts 210 and 211 (cGMP in Manufacturing, Processing, Packing or Holding of Drugs and Finished Pharmaceuticals), Part 225 (Current Good Manufacturing for Medicated Feeds - Subpart B), and Part 226 (Current Good Manufacturing Practice for Type A Medicated Articles - Subpart B).

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