2.2.1.S.2.2 Description of manufacturing process and process controls.......................... 11 2.2.1.S.2.3 Control of materials ............................................................................... 11 2.2.1.S.2.4 Control of critical steps and intermediates................................................. 12 2.2.1.S.2.5 Process validation and/or evaluation ........................................................ 12 2.2.1.S.2.6。制造过程开发........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... 2.2.1.S.4 Control of the Drug Substance ................................................................... 13 2.2.1.S.4.1 Specification(s) ..................................................................................... 13 Additional information for phase II and phase III clinical trials ....................................... 13 2.2.1.S.4.2 Analytical procedures ............................................................................. 13 2.2.1.S.4.3分析程序的验证............................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................. 2.2.1.S.4.5 Justification of specification(s) ................................................................ 14 2.2.1.S.5 Reference standards or materials ............................................................... 14