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Abstract

Formality in Quality Risk Management (QRM) is an interesting concept. What makes a QRM activity ‘formal’ and what makes one ‘informal’? A simplistic viewpoint might be that formal is when a QRM tool is used to manage risks, and informal is when no such tool is used. But is it that simple? And are there different degrees of formality in QRM - is it a spectrum, or is it a binary concept? These questions are explored in this paper. Since the introduction of ICH Q9 in 2005, there have been discussions in the pharmaceutical industry and between regulators regarding the concept of formality in QRM. ICH Q9 presents two principles of Quality Risk Management, and one of those refers to formality – it states that “the level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk”. What formality in QRM means at a practical level is currently not clear. A lack of understanding of this concept has probably led to certain negative consequences – ranging from a lack of scientific rigour being applied during certain complex risk assessments, to the overuse of quite resource intensive and highly formalized QRM activities to address relatively straight forward GMP problems and risk questions. In response to this lack of clarity, regulators and industry representatives initiated work to explore the concept of formality in QRM, with a view to achieving a shared understanding as to what it means at a practical level. It was of interest that there was strong support expressed among industry and GMP inspectors for the use of less formal approaches to QRM. The primary outcome of that work is a set of suggested definitions for formal and less formal approaches to QRM. There are several anticipated benefits to this work – including that a better understanding of formality may lead to resources for QRM being used more efficiently – where lower risk issues are dealt with via less formal means, freeing up resources for managing higher risk issues and more complex problems, which usually require increased levels of rigour and effort.

DOI

https://doi.org/10.21427/16eh-5y47

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Creative Commons Attribution-Noncommercial 4.0 License
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