GMP Publications - Code of Federal Regulation Handbooks by the FDA

GMP - PAT Handbook

10Part11.210.211.820.jpg
978-1-935131-31-1

US FDA Title 21 CFR Parts

Part 11 - Electronic Records/Electronic Signatures (ERES)
Part 210/211 - cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and 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












Quantity   1 - 49     50 - 99     100 - 249     250 - 499     500 - 999     1000+  
Price $14.90 $14.50 $13.85 $11.90 $9.95 $7.70

Quantity   


example: 211, ISBN, Drug, GMP, Etc. - Press Enter
Mix and Match End of Year Special New Spanish Books Featured Publication GCP Device GMP GCP-DRUG Featured Publication
  • Guaranteed Lowest Price
  • Quantity Discounts Available
  • Always Current, Up-To-Date
  • Company Logos Available
  • Special Customizations
  • Pocket-sized 3.75" x 6.25"
  • Prep for FDA & Client Audits
  • Employee Training & Reference
  • Promotional "giveaways"
  • Tradeshows and meetings

Our Valued Clients










Return to the GMP Publications home page View your shopping cart-->