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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for Industry, Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice (cGMP), FDA Draft Guidance for Industry PAT - Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, and much more.
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Book Description ISPE, Official Publisher, 2007. Paperback. Condition: Good. 2 Revised. Ships with Tracking Number! INTERNATIONAL WORLDWIDE Shipping available. May not contain Access Codes or Supplements. May be ex-library. Shipping & Handling by region. Buy with confidence, excellent customer service!. Seller Inventory # 1931879559