GLP Analytical Stability Handbook - 4.5x7.5
US FDA Regulations
- 21 CFR Part 11 - Electronic Records with Scope and Application
- 21 CFR Part 58 - Good Laboratory Practice
- 21 CFR Part 210/211 Drug GMPs
- 42 CFR Part 493 Laboratory Requirements (HHS)
ICH International Council for Harmonisation
- ICH Q1A(R2) Stability Testing of New Drugs
- ICH Q1B Photostability Testing
- ICH Q1C Stability Testing for New Dosage Forms
- ICH Q1D Bracketing and Matrixing Designs for Stability Testing
- ICH Q1E Evaluation of Stability Data
- ICH Q2(R2) Validation of Analytical Procedures
- ICH Q5C Stability Testing of Biological Product
- ICH Q14 Analytical Procedure Development
- ICH M10 Bioanalytical Method Validation and Study Sample Analysis
Organisation for Economic Co-operation and Development
- OECD - General Principles of GLP Series 1
FDA Guidance
- Guidance for Industry ANDAs: Stability Testing of Drug Substances
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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
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