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IPQ Special Report — May 2010

Apr 28th, 2010

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THE QUALITY REGULATORY INITIATIVES UNDERWAY AS THE NEW DECADE BEGINS show the strong imprint of ICH Q8-10 at both the agency and international levels. From CMC application review to GMP inspections, from development to post-market manufacturing, from the ingredient supply chain through product distribution, the quality-by-design, risk management and quality system principles built into the new ICH guidelines are being integrated into industry/regulator interactions and the guidance, policies and initiatives that define them.  As experience with ICH Q8-10 implementation grows, the knowledge gaps that need to be filled are coming into sharper relief,and industry, regulators and academia are in close dialogue on how to fill them.  Managing and regulating the flow of quality-by-design knowledge from development into manufacturing and through the production lifecycle are central challenges on the table.The value of the QbD building blocks is becoming better understood while questions are emerging on how that value can best be realized and with what regulatory implications. The lifecycle interdependence of the Q8-10/QbD components is leading regulators to rethink the way their review and inspection organizations have interacted.

EDITORS’ NOTE:This issue of IPQ analyzes the impact the new QbD paradigm is having on the initiatives and dialogue around reshaping the CMC review process. In the next IPQ issue (June), the focus will shift onto how the inspection and GMP enforcement components of the regulatory picture are being impacted as the quality system foundation for continuous improvement strengthens.


• CDER’s Christine Moore on implementing QbD for drugs (Appendix I, pp. 42-45)
• CDER’s Steven Kozlowski on implementing QbD for biotech products (Appendix II, pp. 46-48)
• EMA’s Evdokia Korakianiti on the implementation of QbD in Europe (Appendix III, pp. 49-53)
• CDER’s Nakissa Sadriehon regulating nanotechnology in therapeutics (Appendix IV, pp. 54-61)
• Genentech’s Christa Hartmann on a new knowledge management paradigm (Appendix V, pp. 62-64)



ICH Focusing On Q8-10 Implementation……p. 3
Drug Substances, Methods Also On ICH Screen……p. 5
ICH Takes On Heavy Metals……p. 5
Cultural Change Takes Time And Effort……p. 6


CDER QbD Experience Expanding……p. 9
The Gaps That Need Filling ……p. 12
Continuous Manufacturing Touted by FDA……p. 13
Biotech QbD Pilot Focuses On Clinical Relevance……p. 14
CDER MAPPs Out Biotech Reviewer/Inspector Roles……p. 15
FDA Generic Drug Review – Through QbR to QbD……p. 17
ICH Vision Taking Shape In EU With PAT Team Help……p. 19
Workshops, New Guidelines Support EMA Efforts……p. 21
Ireland Following Suit With Industry Collaboration……p. 23
FDA, EMA Work On Clearing CMC Change Pathway……p. 24


Risk Management – What’s The Score?……p. 25
Design Space Still Contains Some Rough Edges……p. 26
QbD Puts Spotlight On Knowledge Management……p. 28
The Burden Of Knowledge……p. 29
Models Help Development And Submissions……p. 30
QbD For Analytical Methods Having Strong Impact……p. 32
Application of QbD In Analytics Poses Some Issues……p. 33


NIST Offers Help In Biotech Measurement Standards……p. 34
USP, PQRI Exploring Their Roles……p. 36
QbD Gaining Traction In Non-ICH Countries……p. 40


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