ANDA常见陷系列综述Part I.pdfVIP

2.3.S.4 Control of Drug Substance. Common questions with respect the control of the drug substance can be grouped into four major categories. These categories include: control of impurities (i.e. organic, inorganic, residual solvents, and residual reagents), drug substance identity, physical characteristic controls, and analytical methodology. Each category will be expounded upon with respect to common questions asked after the reviewer assesses sections 2.3.S.4 and 3.2.S.4. Control of impurities The authors noted above that two common question