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.
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.
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.
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
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