GCLP Good Clinical Laboratory Handbook - 4.5x7.5

US FDA Title 21 CFR Parts

- 21 CFR Part 11 - Electronic Records with Scope and Application
- 21 CFR Part 58 - Good Laboratory Practice
- 21 CFR Part 312 - Investigational New Drug Application
- 21 CFR Part 314 - Applications for FDA Approval to Market a New Drug

- 42 CFR Part 493 Laboratory Requirements (HHS)

International Council for Harmonisation

- ICH E6(R3) Good Clinical Practice
- ICH Q1A(R2) Stability Testing of New Drug Substances
- ICH Q1C Stability Testing for New Dosage Forms
- ICH Q1E Evaluation of Stability Data
- ICH Q2(R2) Validation of Analytical Procedures
- ICH Q14 Analytical Procedure Development

OECD - General Principles of GLP Series 1