Pharmaceutical Manufacturers GMP Audit Handbook

The Regulations and Auditor's Check List in one handbook

FDA Title 21 Parts:

• 21 CFR Part 11 - Electronic Records; Electronic Signatures
• 21 CFR Part 11 Scope & Application 2003
  
• The 21 CFR Part 11 Auditor's Check List
  

• 21 CFR Parts 210/211 GMPs for Finished Pharmaceutical Products
  
• 21 CFR Parts 210/211 Auditor's Check List

International Council for Harmonization (ICH):

• ICH Q7 GMPs for Active Pharmaceutical Ingredients
  
• ICH Q7 Auditor's Check List