IPQ May 2010 - Volume 4, No. 1 - Quality Regulatory Initiatives Underway

Sep 8, 2026

May 2010 issue of IPQ examines how the ICH Q8-10 quality-by-design (QbD) paradigm is reshaping regulatory initiatives across agencies and international levels. Coverage spans the full quality lifecycle, integrating CMC review, GMP inspections, development and post-market manufacturing, analytics, and supply-chain to distribution interactions. As implementation experience grows, the publication highlights knowledge gaps, evolving regulator review and inspection models, and the regulatory implications of realizing QbD value. The issue also previews forthcoming discussion in June.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages4

Reading Time10 min

AccessFree to download

ICH

ICH Focusing On Q8-10 Implementation

Drug Substances, Methods Also On ICH Screen

ICH Takes On Heavy Metals

Cultural Change Takes Time And Effort

FDA & EMA

CDER QbD Experience Expanding

The Gaps That Need Filling

Continuous Manufacturing Touted by FDA

Biotech QbD Pilot Focuses On Clinical Relevance

CDER MAPPs Out Biotech Reviewer/Inspector Roles

FDA Generic Drug Review– Through QbR to QbD

ICH Vision Taking Shape In EU With PAT Team Help

Workshops, New Guidelines Support EMA Efforts

Ireland Following Suit With Industry Collaboration

FDA, EMA Work On Clearing CMC Change Pathway

THE ISSUES

Risk Management – What’s The Score?

Design Space Still Contains Some Rough Edges

QbD Puts Spotlight On Knowledge Management

The Burden Of Knowledge

Models Help Development And Submissions

QbD For Analytical Methods Having Strong Impact

Application of QbD In Analytics Poses Some Issues

OTHER ORGANIZATIONS

NIST Offers Help In Biotech Measurement Standards

USP, PQRI Exploring Their Roles

QbD Gaining Traction In Non-ICH Countries

TM PR EVI EW SAM PLE INTERNATIONAL PHARMACEUTICAL QUALITY TM WWW.IPQPUBS.COM MAY 2010 | VOL. 4, NO. 1 | $1000 PER YEAR 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-bydesign 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 will analyze 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 howthe inspection and GMP enforcement components of the regulatory picture are being impacted as the quality system foundation for continuous improvement strengthens. VOICES FROM THE DIALOGUE: • 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 Sadrieh on regulating nanotechnology in therapeutics (Appendix IV, pp. 54-61) • Genentech’s Christa Hartmann on a new knowledge management paradigm (Appendix V, pp. 62-64) TABLE OF CONTENTS: ICH ICH Focusing On Q8-10 Implementation .............3 Drug Substances, Methods Also On ICH Screen .......5 ICH Takes On Heavy Metals .......................5 Cultural Change Takes Time And Effort ..............6 FDA & EMA CDER QbD Experience Expanding ..................9 The Gaps That Need Filling ......................12 Continuous Manufacturing Touted by FDA ..........13 Biotech QbD Pilot Focuses On Clinical Relevance .....14 CDER MAPPs Out Biotech Reviewer/Inspector Roles ..15 FDA Generic Drug Review– Through QbR to QbD ....17 ICH Vision Taking Shape In EU With PAT Team Help ..19 Workshops, New Guidelines Support EMA Efforts ....21 Ireland Following Suit With Industry Collaboration ....23 FDA, EMA Work On Clearing CMC Change Pathway ...24 THE ISSUES Risk Management – What’s The Score? ............25 Design Space Still Contains Some Rough Edges .....26 QbD Puts Spotlight On Knowledge Management .....28 The Burden Of Knowledge .......................29 Models Help Development And Submissions ........30 QbD For Analytical Methods Having Strong Impact ...32 Application of QbD In Analytics Poses Some Issues . .33 OTHER ORGANIZATIONS NIST Offers Help In Biotech Measurement Standards .34 USP, PQRI Exploring Their Roles .................36 QbD Gaining Traction In Non-ICH Countries .........40 INSIDE THE GLOBAL REGULATORY DIALOGUETM IPQ INTERNATIONAL PHARMACEUTICAL QUALITY THE PHARMACEUTICAL QUALITY REGULATORY initiatives underway at both the agency and interna tional levels as the new decade begins show the strong imprint of the quality by design (QbD), risk management and quality system principles embedded in the ICH Q8-10 guidelines. The r

FAQs

What core regulatory principles does the issue connect to ICH Q8-10?

The issue links ICH Q8-10 to quality-by-design, risk management, and quality system principles. It describes how these principles are integrated into interactions between industry and regulators across the quality lifecycle.

How does the publication describe the impact of the QbD paradigm on CMC review and inspections?

It states that the regulatory impact extends from marketing application review to GMP inspections. It also notes that regulators are rethinking how review and inspection organizations have interacted in light of Q8-10/QbD components.

What themes related to knowledge gaps and knowledge management are emphasized?

The issue highlights that implementation experience is making knowledge gaps more visible. It also emphasizes managing and regulating the flow of QbD knowledge from development into manufacturing, alongside evolving knowledge management approaches.

Sep 8, 2026

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