Active Pharmaceutical Ingredients: June 2007 (Baseline Pharmaceutical Engineering Guides)

This revised Guide builds on the original principles of ISPE's Baseline® Guide Volume 1, Active Pharmaceutical Ingredients (originally entitled Bulk Pharmaceutical Chemicals). It also incorporates and builds on new regulations and guidance, such as ICH Q7, ICH Q9, GAMP® 4, 21 CFR Part 11, Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice (cGMP), FDA Draft Guidance for Industry PAT - Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, and much more.