GLP Manufacturing Handbook - 4.5x7.5

US FDA Title 21 CFR Parts:

• 21 CFR Part 11 - Electronic Records; Electronic Signatures
  
• 21 CFR Part 11 - Scope & Application 2003
• 21 CFR Part 58 - Good Laboratory Practice for Non-Clinical Studies
  
•  21 CFR Parts 210/211 Drug GMPs
  
• 21 CFR Part 610 - General Biological Products Standards
• 42 CFR Part 493 Laboratory Requirements (HHS)

Guidance:

• EU Annex 1 - Sterile Medicinal Products

ICH International Council for Harmonisation:

• ICH Q1A(R2) Stability Testing of New Drugs
• ICH Q2(R2) Validation of Analytical Procedures
• ICH Q7 GMPs Active Pharmaceutical Ingredients (APIs)
• ICH Q14 Analytical Procedure Development 

Organisation for Economic Co-operation and Development:

• OECD - General Principles of GLP Series 1

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