IPQ Monthly Update – April 2021 in Review

The feature story in the April issue explores how regulators and industry are working together to make quality risk management (QRM) a more effective force in improving quality systems and the regulatory communication process at the review and inspections levels. The three parts of the story provide insights from: ● HPRA’S Kevin O’Donnell on the evolution of QRM and the revision now underway of ICH’s 15-year-old QRM guideline Q9, which he is leading ● FDA’s Rick Friedman, also on the Q9 revision Expert Working Group, on advancing aseptic processes through QRM, and ● industry/academia thought leaders on evolving QRM’s relationship with knowledge management across the product lifecycle.

Pandemic Urgencies Highlight Constraints in Manufacturing Change Regulatory Paradigm and Where Adjustments Are Needed

The pressing need during the COVID-19 pandemic to accelerate product development and rapidly accommodate the shifting manufacturing and distribution demands has shed strong light on the constraints in the existing quality regulatory framework and the pathways to reducing them.

Part I: Industry Quality Leaders on the Global PAC Regulatory Problem and Solutions

Part II: Evolving the Quality Regulatory Paradigm at the Global Level

Regulators Are Exploring with Industry How to Strengthen Quality Risk Management Practices, with Revision of ICH Q9 a Key Focal Point

Regulators and industry are sitting down together to mine their experience and map out some clearer directions and expectations about what is needed to empower quality risk management (QRM) in improving the pharmaceutical quality system (PQS) and the industry/regulatory communication process at the review and inspection levels.

Part I: ICH Q9 Revision Lead O’Donnell on the Evolution of QRM

Part II: FDA’s Rick Friedman on Advancing Aseptic Processing through QRM

Part III: Industry/Academia Thought Leaders on the Evolving QRM/KM Relationship

IPQ Monthly Update – March 2021 in Review

The March issue provides a wealth of insights shared by FDA, EMA and PMDA biotherapeutic and vaccine regulators on the challenges, opportunities, and learnings as they have sought to support the accelerated product development and review called for by the pandemic, while assuring that CMC/quality standards are met and keeping up with their non-COVID-related workload. Included are updates on the guidances and other quality-related initiatives impacting vaccines and biotherapeutics that have been forthcoming during the first quarter of 2021.

Regulators Share Pandemic’s CMC Impact at CASSS Japan Forum; Guidance Output Continues Apace in Q1 2021

This four-part story explores the significant impact of the pandemic during 2020-2021 on the CMC review processes for vaccines and biotherapeutics at FDA, EMA and Japan’s PMDA in their efforts to support accelerated product development and review, while assuring that quality standards are met and the ongoing non-COVID-related workload addressed.

Part I: EMA Perspective

Part II: FDA CBER Perspective

Part III: FDA CDER Perspective

Part IV: Panel Discussion Among US, Europe, and Japan Regulators

IPQ Monthly Update – February 2021 in Review

The issue focuses on how academia and industry are collaborating to address the pressing needs in biopharma workforce development, in recognition of the challenges of keeping pace with the rapidly evolving process and product technologies and the cross-functional understanding and skills needed to support them. The six-part coverage explores the dimensions of these challenges and the collaborations that are being formed and strengthened to address them.

Academia/Industry Collaboration Intensifies on Addressing the Pressing Needs in Biopharma Workforce Development

Academia and industry are collaborating more intensely on addressing the pressing needs in biopharma workforce development, in recognition of the challenges of keeping pace with the rapidly evolving process and product technologies and the cross-functional understanding and skills needed to support them.

Part I: NIIMBL’s Engagement with Academia on Workforce Development Needs

Part II: ISPE Workforce of the Future Traction at UMBC and UC Davis

Part III: Keck Institute’s Behrens on Biopharma Talent Needs and KGI/Industry Partnering

Part IV: Xavier’s Phillips on Sharable Quality and Regulatory Science Curriculum

Part V: CASSS Panel on Opening Up Biopharma Career Pathways

Part VI: European and Global Workforce Development Collaborations

IPQ Monthly Update – January 2021 in Review

Drawing attention in the January issue are: ● how the research, technologies and partnerships that have been gelling in recent years made possible the rapid development of a coronavirus vaccine in 2020 ● how USP has intensified its focus on supply chain vulnerabilities and vaccine/treatment development to help support the pandemic response, and ● FDA’s ongoing progress in improving the usefulness and user-friendliness of its inactive ingredient database (IID).

Latest Improvements in FDA’s Inactive Ingredient Database Include Change Log and Use of Maximum Daily Exposure

FDA’s latest efforts to improve the functionality of its Inactive Ingredient Database (IID) include a quarterly log to track changes in the records and the use of the term “maximum daily exposure” (MDE) in lieu of “maximum potency.”

Recent Technology and Partnership Advances Made Possible Precision and Speed of Vaccine Response to Pandemic, NIAID’s Graham Stresses at CASSS WCBP Conference

The precision and speed of COVID-19 vaccine development was made possible by recent R&D advancements and a strengthened network of public-private partnerships, NIH National Institute for Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VCR) Deputy Director Barney Graham affirmed in his keynote presentation at the opening session of the CASSS Well-Characterized Biotechnology Products (WCBP) conference in late January.