Warning Letters and European Non-Compliance Reports - IPQ.org
[table id=27 /]

Implementing ICH Q9(R1) Will Entail a Heightened Focus on Integrating Knowledge into Risk-Based Decision-Making

Full implementation of the revisions that have been made to ICH’s Q9 guideline on quality risk management (QRM) will entail a heightened focus on how to best integrate knowledge into risk-based decision-making (RBDM) and is expected to be a mid-term rather than short-term project, according to the rapporteur and members of the guideline revision Expert Working Group (EWG).

Part I: Insights from Expert Working Group Members on ICH Q9 Revisions

Part II: Panel Discussion Among PRST Meeting KM/QRM Experts

[The Introduction is openly available. Parts I - II are available to subscribers. Parts III - IV of the story will be released over the next few days.]

IPQ Monthly Update – May/June 2023 in Review

The first of the two interrelated stories featured in our May/June Monthly Update focuses on titanium dioxide (TiO2) as a good case study of the layers of challenges that come into play as food, chemical, and environmental concerns get translated into the medicines arena. The second five-part story delves more broadly into the challenges of designing and implementing constructive and viable environmental policies that do not carry with them unintended consequences for medicines. The parts explore: ● the need for pharma stakeholder engagement ● EU PFAS action and pharma mitigation needs ● F-gases and hydrofluorocarbons in inhalation products ● a DIA Europe legislative session panel discussion, and ● the TiO2/nanoparticle dialogue at a June PQRI workshop.

Industry is Urging EMA to Increase its Focus on Medicine Impact of EU Food,...

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is stressing that food, chemical, and environmental legislation should be developed and implemented with the impact on medicines in mind and that EMA and other regulatory authorities and stakeholders need to be more directly engaged to make sure that the outcomes align with the EU’s healthcare objectives.

PART I: The Need for Pharma Stakeholder Engagement

PART II: EU PFAS Action and Pharma Mitigation Needs

PART III: Industry and EMA on F-gases and Hydrofluorocarbons in Inhalation Products

PART IV: DIA Europe Legislative Session Panel Discussion

PART V: Intensified Industry Dialogue on TiO2 and Nanoparticles Ahead of More EMA Review

IPEC is Helping Marshal Expertise Across Stakeholders to Forestall a Potential Titanium Dioxide Ban...

The International Pharmaceutical Excipients Council (IPEC) is working with other groups of experts across the stakeholder community to prevent questionable safety concerns raised in Europe about the use of titanium dioxide in foods from resulting in a ban on its use in formulating drug products.

Because of a link between food and pharma legislation in Europe, a January 2022 EU regulation removing titanium dioxide (TiO2) from the list of authorized food additives could result in it not being allowed in pharmaceuticals, unless a second review by the European Medicines Agency – to be completed by April 2024 – provides sufficient justification for its continued use. Industry input to the updated EMA review is due by November 2023.

[To help expand awareness of the TiO2 issue and its implications, IPQ is making the full story openly available. Click here to read the story.]

IPQ Monthly Update – March/April 2023 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 2023 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