1. General Principles and Regulatory Considerations: Specifications and Shelf Life Setting;Riley,2019
2. Q Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods;Lloyd,2020
3. ICH Q6B Guideline “Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products”,1999
4. ICH Q10 Guideline, “Pharmaceutical Quality System”,2009
5. ICH Q11 Guideline, “Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/biological Entities)”,2012