Warning Letters and European Non-Compliance Reports | IPQ.org
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IPQ Monthly Update – March/April in Review

Developing standards in a fast-moving arena like biotechnology is a challenging task. The four-part feature story in IPQ’s Monthly Update for March and April explores what USP has been able to achieve and where it is looking to expand its contribution, in collaboration with industry, government and academic stakeholders, through a “solutions-based” approach that focuses on the development of standards addressing assay and process performance. Also shared is what CBER reviewers are seeing and advising in reviewing CGT CMC applications – in particular, regarding the challenges of potency testing for CAR T cell therapies.

USP Continues to Refine Its Strategies for Keeping Pace with and Supporting the Rapidly...

USP is continuing to evolve and refine its strategies for providing standards that can keep pace with and support the rapid advances in biotechnology taking place across the monoclonal antibody (mAb), vaccine, and the cell and gene therapy (CGT) landscape.

Part I: USP Bio Stakeholder Forum Opening Remarks and Mass Spec Standards for Proteins

Part II: USP's CGT Initiatives

Part III: FDA and Industry Experience with CAR T Potency Testing

Part IV: Update on USP Strategies and Initiatives in the MAb, Vaccine, and CGT Arena

IPQ Monthly Update – January/February in Review

The story featured in IPQ’s January/February Monthly Update explores how the US government is continuing to strengthen its collaborative efforts with industry and academia to de-risk and accelerate manufacturing innovation as the learnings from the pandemic get further digested. The five-part story provides a wealth of insights from key leaders and policy makers on the innovation issues at play and how the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and other organizations are seeking to address them in the US and internationally.

Government/Industry/Academia Collaborative Efforts to De-Risk and Accelerate Manufacturing Innovation Draw Strength from Pandemic Learnings

The US government is continuing to strengthen its collaborative efforts with industry and academia to de-risk and accelerate manufacturing innovation, as the learnings from the pandemic are further digested. The five-part IPQ story provides a wealth of insights from key leaders and policy makers on the innovation issues at play and how NIIMBL and other organizations are seeking to address them in the US and internationally.

Part I: NIIMBL and its “Going First Together” Mantra

Part II: US Manufacturing Innovation Leaders Weigh In

Part III: The Importance of Process and Facility Innovation in Global Health

Part IV: Charting the Advanced Therapy CMC Pathways and Other NIIMBL Projects

Part V: CBER’s Marks on Taking CGTs to the Next Level

IPQ Monthly Update – December 2022 in Review

The story featured in IPQ’s December 2022 issue focuses on the issues that have arisen and the progress that has been made in implementing the risk-based assessment strategy for elemental impurities (EIs) provided in ICH Q3D. The four parts of the story address: ● the role of a watershed workshop cosponsored by the Product Quality Research Institute (PQRI) and FDA ● the perspectives and experience of US and European regulators ● USP and Ph. Eur. harmonization with ICH Q3D, and ● the outcomes of a PQRI study on variability in EI analysis.

ICH Q3D Implementation Continues with Workshops, Research, and Guideline and Pharmacopeial Revisions

More sensitive and selective methodologies have facilitated the identification and quantification of elemental impurities (EIs) in pharmaceuticals and the movement away from the old heavy metal analytical tests to the newer risk-based assessment strategy of ICH Q3D.

Part I: Role of PQRI/FDA Workshop in Q3D Implementation Dialogue

Part II: Regulatory Experience and Perspectives in Implementing Q3D

Part III: Pharmacopeial Harmonization with ICH Q3D

Part IV: Outcomes of PQRI Study on Variability in Elemental Impurity Analysis

IPQ Monthly Update – November 2022 in Review

The experience of the pandemic has underscored the criticality of assuring that regulatory processes keep pace with innovation in the manufacturing and control arena and has spurred the efforts that were underway in Europe to assess the issues involved and implement the adaptations needed to address them.  The three parts of the IPQ story featured in IPQ’s October 2022 issue address the progress of these efforts.

Strengthened European Regulator Support for Advanced Technologies Includes New EMA Quality Innovation Group

The experience of the pandemic has underscored the criticality of assuring that regulatory processes keep pace with innovation in the manufacturing and control arena and has spurred the efforts that were underway in Europe to assess the issues involved and implement the adaptations needed to address them. The three parts of the IPQ story review the progress of these efforts.

Part I: Europe’s Focus on CMC Innovation and Agile Regulation

Part II: Innovation Issues Explored at CASSS CMC Forum in Europe

Part III: MHRA’s “New Era in Regulation”

IPQ Monthly Update – October 2022 in Review

The story featured in IPQ’s October 2022 issue focuses on how EMA’s toolbox on CMC flexibilities has been evolving to incorporate industry input and learnings from the pandemic. The three parts of the story center around the discussions that took place at a session of the October 2022 CASSS CMC Strategy Forum at which regulator and industry leaders shared their experiences and learnings in applying flexibility tools from a regional and global perspective.

EMA Toolbox on CMC Flexibilities has been Evolving to Incorporate Industry Input and Learnings...

EMA’s “toolbox guidance on scientific elements and regulatory tools to support quality data packages” for priority medicines targeting unmet medical needs, released in April 2022, reflects extensive stakeholder input and will evolve further as experience and learnings from the pandemic are evaluated.

Developed as an outcome of the 2018 joint EMA/FDA workshop on quality support to Priority Medicines (PRIME) and Breakthrough Therapy (BT) designated products, the guidance outlines the tools available in the EU to address the challenges in generating robust quality packages under accelerated conditions. It is applicable to small molecules, biological/biotech products, and advanced therapy medicinal products (ATMPs).

The guidance was drafted, consulted on, and revised throughout the COVID pandemic.

Part I: EMA Perspective on its Toolbox Guidance and OPEN Initiative

Part II: Industry View on Efficiency Tools and CMC Flexibility Learnings from COVID

Part III: Panel Discussion on Effective Tools for the Future