OPS/OC/ONDQA/OGD - NIHS

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Designing Product and Processes to Meet Target Product Quality Profile • Product Design – Physical, chemical, and biological properties of drug substance – Biopharmaceutics Classification System (BCS) and formulation development • Process Design – Mechanical properties, flow properties, and others – Unit operation selection – Identification of process parameters and material attributes 11
Identifying Critical Material Attributes, Process Parameters, and Sources of Variability I N P U T S (X) Process Measurement Material Environment Y = ƒ(X) Priori knowledge Risk Assessment Design of Experiments Inputs to the process control variability of the Output Y OUTPUT Material Attributes 12
Page 1 and 2: 添付資料 3 FDA visit agenda
Page 3 and 4: 添付資料 4-a FDA 後発医
Page 23 and 24: 添付資料 4-b FDA 後発医
Page 31 and 32: QbR is a System Generic Drug Applic
Page 33 and 34: Janet Woodcock on QbD J. Woodcock.
Page 35 and 36: ISPE PQLI on QbD, Sept. 14, 2007
Page 37 and 38: Overview of QbD Labeled Use Safety
Page 39: Target Product Quality Profile: Beg
Page 43 and 44: Critical Quality Attribute • “A
Page 45 and 46: Design Space • Design Space - The
Page 47 and 48: Controlling Input Materials and Man
Page 49 and 50: QbR Questions Provides a Roadmap
Page 51 and 52: How Does QbR Implement QbD Product
Page 53 and 54: How Does QbR Implement QbD Material
Page 55 and 56: How Does QbR Implement QbD Process
Page 57 and 58: Conclusion • The FDA OGD has deve
Page 59 and 60: 2.3.P.2.4 Container Closure System
Page 61 and 62: 添付資料 4-e FDA 新医薬

OPS/OC/ONDQA/OGD - NIHS

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