Warning Letters and European Non-Compliance Reports | IPQ.org
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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

IPQ Monthly Update – August/September 2022 in Review

The two stories featured in IPQ’s August/September 2022 issue explore: ● the dialogue now going on among regulators, pharmacopeias, and industry on the challenges associated with the manufacturing, characterization, and QC of nanoparticle-based formulations, and ● how CBER’S Advanced Technologies Program (ATP) is being strengthened through the expansion of internal and external funding, scientific and regulatory expertise, and CBER Advanced Technologies Team (CATT) collaboration, and the recent experience of CDER’s Emerging Technology Team (ETT).

CBER’s Advanced Technologies Program Growing Stronger with Increased Funding, Expertise, and Collaboration

CBER’S Advanced Technologies Program (ATP) is being strengthened through the expansion of internal and external funding, scientific and regulatory expertise, and collaborative support through the CBER Advanced Technologies Team (CATT). As part of its efforts to promote the adoption of advanced manufacturing, CATT has joined with CDER’s Emerging Technologies Team (ETT) to form the Center for the Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals (CAMPB). The Office of Regulatory Affairs and other centers are also expected to participate in the center’s activities.

mRNA-LNP Vaccines Spur Global Dialogue on Nanomaterial Standards and Regulatory Approaches

The successful development of mRNA-lipid nanoparticle (LNP) vaccines to address the COVID-19 pandemic has highlighted the power of nanoparticle-based formulations in producing safe and efficacious medicinal products.

Part I: Pfizer/BioNTech Lipid Challenges with mRNA-LNP COVID Vaccine

Part II: FDA’s Novel Excipient Review Pilot Program and Nanomaterials Guidance

Part III: USP’s Draft Guideline and Other Efforts on mRNA Vaccine Quality

Part IV: The EDQM Nanomedicines Dialogue and WHO on Regulating mRNA Vaccine Quality

Part V: Potency Assays for mRNA-LNP Vaccines

IPQ Monthly Update – June/July 2022 in Review

The four-part story featured in IPQ’s June/July Monthly Update explores how an FDA-commissioned study carried out though the National Academies of Sciences, Engineering, and Medicine (NASEM) is helping drive the industry/regulator dialogue and agenda on advancing innovation in pharmaceutical manufacturing. With a workshop held on the study report as a central point of reference, the four parts cover: ● the study’s focus, aim, process, organizations involved, and recommendations ● the mechanisms that are now in place to enable innovation ● the challenges and opportunities that are presenting themselves, and ● the path forward. Included are updates on related developments and discussions since the workshop was held.

NASEM-Led Study for FDA is Helping Drive Industry/Regulator Agenda on Innovation Needs

An FDA-commissioned study carried out through the National Academies of Sciences, Engineering, and Medicine (NASEM) is helping drive the industry/regulator agenda on advancing innovation in pharmaceutical manufacturing.

PART I: The NASEM Study and FDA Reflections

PART II: Existing Mechanisms to Enable Innovation

PART III: Challenges and Opportunities

PART IV: The Path Forward