Warning Letters and European Non-Compliance Reports - IPQ.org
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The Challenges of Evolving Pharma from a Compliance to a Risk-Based Control Strategy Mindset...

The challenges of and drivers for evolving the pharmaceutical industry from a compliance-oriented mindset to one based on a control strategy embodying the risk management principles of ICH Q9(R1) are at the forefront of the industry/regulator dialogue at public forums, as the complexities of processes, products, and big data handling continue to expand.

The Q9 revision, released in 2023, provides a clearer roadmap on embedding quality risk management (QRM) into a quality system and control strategy.

PART I: Critical Thinking in Risk Management and Data Governance

Parts II - IV will be posted over the next week.

Weekly Supplement: Week Ending February 16, 2024

Helping set the context for the discussions that ensued at this year’s Association for Accessible Medicines (AAM) Annual Meeting, held in Tampa Florida in early February, was a review of the top FDA priorities in the generic drug regulatory arena and how the agency was seeking to address them by Center for Drug Evaluation and Research (CDER) Deputy Director Jacqueline Corrigan-Curay.

Weekly Supplement: Week Ending February 9, 2024

The design of appropriate in-use stability testing protocols requires strategic risk-based thinking, affirmed Health Canada (HC) Senior Biologist/Evaluator Paula Russell at a CASSS CMC Strategy Forum on in-use stability, held in late January in Washington, D.C. in conjunction with CASSS’ 2024 Well Characterized Biological Products (WCBP) Conference.

Weekly Supplement: Week Ending February 2, 2024

In reviewing EMA’s efforts to support manufacturing digitalization at the 2023 ISPE Pharma 4.0 and Annex 1 Conference, held in Vienna in December 2023, the agency’s Quality and Safety of Medicines Head, Evdokia Korakianiti, stressed the importance of global regulatory alignment to fully realize the quality, efficiency and product supply benefits that the IT advancement offers.

Weekly Supplement: Week Ending January 26, 2024

In reviewing the strategic priorities and actions of FDA’s Office of Combination Products, its leaders are pointing to an increased focus on convergence across global jurisdictions, with the goal of achieving a more consistent, efficient, risk-based regulatory approach to the combined use of drug, device, and/or biologic medical products.

IPQ Monthly Update – September/October 2023 in Review

The advancing CMC innovation support programs at EMA and FDA are highly complementary in focus and structure, with distributed and continuous manufacturing drawing significant up-front attention at both agencies. The four-part story featured in IPQ’s September/October Monthly Update explores the significant effort underway to deepen the regulator/industry/academia communication needed to realize the potential for technological advancement in the manufacturing and control arena, and in CM and DM in particular.

CMC Innovation Support Programs Advance at EMA and FDA, with Distributed and Continuous Manufacturing...

The advancing CMC innovation support programs at EMA and FDA are highly complementary in focus and structure, with distributed and continuous manufacturing drawing significant up-front attention at both agencies.

On both sides of the Atlantic, a significant effort is underway to deepen the regulator/industry/academia communication needed to realize the potential for technological advancement in the manufacturing and control arena. In this four-part story, IPQ explores the latest advancements in the EMA and FDA innovation support programs and the priorities that are now drawing front-burner attention.

PART I: European Regulatory Network Support for Manufacturing Innovation

PART II: FDA’s Expanding Engagement with Advanced Technologies

PART III: Barriers to CM Adoption Explored at USP/RAPS Workshop

Part IV: Distributed/POC Manufacturing and the CMC/Quality Regulatory Paradigm

IPQ Monthly Update – July/August 2023 in Review

Regulator and industry understanding and implementation of quality risk management in drug manufacturing and control has been advancing and ICH has revised its QRM guideline Q9 accordingly. The four-part story featured in IPQ’s July/August Monthly Update includes insights from the rapporteur and other Expert Working Group members involved in drafting the revisions – as well as from other QRM experts – on the issues addressed and the implementation expectations and challenges. Parts III and IV of the story home in on two of the areas drawing attention in Q9(R1) – risk-based decision-making and product availability risks, respectively.

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

Part III: Risk-Based Decision-Making

Part IV: Risk Management in Drug Shortage Prevention

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.