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GLP Analytical Stability Handbook - 4.5x7.5

GLP Analytical Stability Handbook - 4.5x7.5

SKU:978-1-935131-07-6

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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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