OPS/OC/ONDQA/OGD - NIHS

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$Allergies to cross-reactive plant proteins. Latex-fruit ... - NIHS$

FDA’s Pharmaceutical cGMP for the 21 st Century QbD Initiative Generic Sponsor: Implementing QbD in development and manufacturing FDA <strong>OGD</strong>: Developed a Questionbased Review System that assesses sponsor’s QbD ANDAs 19
QbR Questions Provides a Roadmap • Questions guide reviewers – Prepare a consistent and comprehensive evaluation of the ANDA – Assess critical formulation & manufacturing variables • Questions guide industry – Recognize issues <strong>OGD</strong> generally considers critical – Direct industry toward QbD • Questions inform readers of the review – How QbD was used in the ANDA – Provide the basis for a risk assessment 20
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 and 40: Target Product Quality Profile: Beg
Page 41 and 42: Identifying Critical Material Attri
Page 43 and 44: Critical Quality Attribute • “A
Page 45 and 46: Design Space • Design Space - The
Page 47: Controlling Input Materials and Man
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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