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For convenience, we compiled some useful links, that we hope you find handy!
QbD/ Lifecycle Approach for Analytical Procedures
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ICH Q9: Quality Risk Management
ICH Q10: Pharmaceutical Quality System
ICH Q11: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES)
ICH Q8 (R2): PHARMACEUTICAL DEVELOPMENT
Analytical Procedure Lifecycle Management: Current Status and Opportunities, Pharmtech, Dec 2018
ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation, 14 November 2018 Final Concept Paper:
ICHQ12 TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT
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