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PDA DHI Technical Books

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Technical Reports: Electronic

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PDA Pocket Guides


Pocket Code of Federal Regulations GMP Guide – 2011 Edition
21 CFR Part 210-CGMP in Manufacturing, Processing, Packing, or holding of drugs; general. 21 CFR Part 211–CGMP for Finished Pharmaceuticals. Reproduced in pocket size by PDA. 2011
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Pocket Code of Federal Regulations: ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
This guide is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.
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