药物质量设计的实用方法 407条(本栏目收费,不能显示细节,电话15274084725)
11.9 Real乚Time Release Testing and Continuous Quality Verification 316 316
11.10 Acknowledgments 317 317
12 Regulatory Guidance 321 321
Siegfried Schmitt and Mustafa A. Zaman 0
12.1 Introduction 321 321
12.2 The Common Technical Document (CTD) Format 322 322
12.2.1 Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) 324 324
12.2.2 Quality Risk Management (ICH Q9) 324 324
12.2.3 Product and Process Development (S.2.6 and P.2) 325 325
12.2.4 Control Strategy 326 326
12.2.5 Design Space (Optional) 327 327
12.3 Essential Reading 328 328
12.4 What Is Not Written, or Hidden, in the Guidance Documents? 329 329
12.5 Post乚Approval Change 330 330
Analytical method development, 264 264
ruggedness, 266, 274–8 278
Analytical target profile, 131 131
Common technical document (CTD), Qb Drelated issues, 322–3 323
Continued process verification, 153, 223, 268, 299–300 300
statistical process control, 268–9 269
Continuous improvement, 153–4 154
Continuous manufacture, 144, 302, 309–16 316
Continuous processing, 123, 144, 245, 310–13,315, 316 316
Continuous quality verification (CQV), 316–17 317