GLP Manufacturing Handbook - 4.5x7.5

Regulations:

US FDA Title 21 CFR Parts

- 21 CFR Part 11 - Electronic Records
- 21 CFR Part 58 - Good Laboratory Practice
- 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