GMP - PAT Handbook

CFR Title 21 Food & Drugs (Revised as of April 1, 2010)

-    Part 11 -   Electronic Records; electronic Signatures

-    Part 210 - Current Good Manufacturing Practice in
                 Manufacturing, Processing, Packing or Holding
                 of Drugs; General

-    Part 211 - Current Good Manufacturing Practice for        
                 Finished Pharmaceuticals

-    Part 820 - Quality System Regulation

FDA Guidance for Industry

-    Part 11 - Electronic Records; electronic Signatures – Scope and Application

-    ICH Guideline on GMP for Active Pharmaceutical Ingredients (ICH Q7)

-    Current Good Manufacturing Practices (cGMP) for Drugs Auditor’s Check List

-    PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

-    Drug Manufacturing Inspections: Compliance Manual for FDA Staff (7356.002)

-    Quality Systems Approach to Pharmaceutical CGMP Regulations