Pandemic Urgencies Highlight Constraints in Manufacturing Change Regulatory Paradigm and Where Adjustments Are Needed

The pressing need during the COVID-19 pandemic to accelerate product development and rapidly accommodate the shifting manufacturing and distribution demands has shed strong light on the constraints in the existing quality regulatory framework and the pathways to reducing them.

In this two-part story, we explore where ICH Q8-12 efforts to evolve the lifecycle regulatory paradigm to be more transparent, cohesive, harmonized, knowledge- and risk management-based, and continuous improvement-friendly have not yet been realized, and where the deeper solutions to the problems may lie.

Part I: Industry Quality Leaders on the Global PAC Regulatory Problem and Solutions

At the DIA Latin American Regulatory Conference in February, Intarcia Site Head and Global Quality VP Anders Vinther offered the perspective of the One Voice of Quality (1VQ) – a grouping of quality leaders across the major pharma companies focused heavily on the global post-approval change (PAC) issues. Vinther addressed: ● the current PAC situation, including the complications for a company in making single and multiple changes in the global context and the impact of the pandemic ● the ICH vision and the options to reduce complexity in the current paradigm, and ● the 1VQ PAC mission and efforts to advance it. Regulatory reliance, tighter approval timelines, and shifting more PACs from regulatory submission to pharmaceutical quality system (PQS) oversight are among the solutions 1VQ is advocating. Included is a review of 1VQ’s publications to date, which are intended to help progress the regulatory framework discussions and industry practices in alignment with PIC/S’ 2019 PAC management guideline.

Part II: Evolving the Quality Regulatory Paradigm at the Global Level

The second part of the story takes a higher-level view of the existing quality lifecycle regulatory paradigm and how it could be evolved to be more knowledge- and risk management-based, and better foster process improvement. The analysis is based on IPQ’s extensive coverage of the dialogue around lifecycle management as it increased in intensity with the development of ICH Q8-10 and further intensified with the launching of the Q12 PAC initiative. In focus in this part are: ● knowledge management (KM) in the ICH Q8-12 context ● the issue of knowledge transparency ● the contradictions and constraints of the current PAC regulatory paradigm, and ● where deeper solutions to addressing the problems may lie.

[Editor’s Note: A COVAX CMC workshop was held in March 2021 to explore “best practices for post-approval changes” in the context of the experience and learnings of the world’s major vaccine suppliers and WHO in facing the PAC challenges presented by COVID-19 and Ebola. A companion story will follow in IPQ with in-depth coverage of the important discussions that took place at the workshop.

Further coverage will be forthcoming from IPQ related to the significant efforts by regulators and industry to implement ICH Q12 and realize its objectives.

Click here for a listing of the last decade of IPQ’s extensive coverage of the global QRM/KM/PAC dialogue and developments. The listing, with links to the coverage, was included with IPQ’s last story, released on April 29, which focuses on the lifecycle regulatory issues from a QRM and KM perspective.]

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