The composition of proprietary materials (e.g. capsule shells, * * * * * colouring blends, imprinting inks) should be submitted, if applicable. Pharmaceutical Development to ICH Q8 Part II Annex for the documentary requirements for development and manufacturing processes that adopt the principles of enhanced approach – 3.2.P.2 (QbD) Refer to Guidance document, Section 15.3.2 or 18.3.2 for details. Components of the Drug Product 3.2.P.2.1 3.2.P.2.1.1 Drug Substance Excipients 3.2.P.2.1.2 The choice of excipients listed in 3.2.P.1, their concentration and characteristics that can influence the drug product performance should be discussed and submitted. The use of antioxidant(s) and/or preservative(s), and their concentration(s) should be explained, fully justified and submitted, if applicable. Drug Product 3.2.P.2.2 3.2.P.2.2.1 Formulation Development 3.2.P.2.2.2 Overages The use of overages should be explained, fully justified and submitted, if applicable. 3.2.P.2.2.3 Physicochemical and Biological Properties 3.2.P.2.3 Manufacturing Process Development 3.2.P.2.4 Container Closure System
The composition of proprietary materials (e.g. capsule shells, colouring blends, imprinting inks) should be submitted, if applicable. * * * * * 3.2.P.2 Pharmaceutical Development to ICH Q8 Part II – Annex for the documentary requirements for development and manufacturing processes that adopt the principles of enhanced approach (QbD) Refer to Guidance document, Section 15.3.2 or 18.3.2 for details. 3.2.P.2.1 Components of the Drug Product 3.2.P.2.1.1 Drug Substance 3.2.P.2.1.2 Excipients The choice of excipients listed in 3.2.P.1, their concentration and characteristics that can influence the drug product performance should be discussed and submitted. The use of antioxidant(s) and/or preservative(s), and their concentration(s) should be explained, fully justified and submitted, if applicable. 3.2.P.2.2 Drug Product 3.2.P.2.2.1 Formulation Development 3.2.P.2.2.2 Overages The use of overages should be explained, fully justified and submitted, if applicable. 3.2.P.2.2.3 Physicochemical and Biological Properties 3.2.P.2.3 Manufacturing Process Development 3.2.P.2.4 Container Closure System
Appendix%202A_Application%20checklist_ICH_NDA_GDA.docx