{"id":4706,"date":"2023-02-15T14:54:38","date_gmt":"2023-02-15T14:54:38","guid":{"rendered":"https:\/\/www.thermofisher.com\/blog\/analyteguru\/quality-risk-management-know-the-risks\/"},"modified":"2023-10-13T21:19:18","modified_gmt":"2023-10-13T21:19:18","slug":"quality-risk-management-know-the-risks","status":"publish","type":"post","link":"https:\/\/www.thermofisher.com\/blog\/analyteguru\/quality-risk-management-know-the-risks\/","title":{"rendered":"Quality Risk Management: Know the Risks"},"content":{"rendered":"
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Editor’s note: This is the first in a series of four blog posts on quality risk management and how you can stay on top of expected regulatory updates in 2023.<\/em><\/p>\n

The start of a new year always brings a sense of proactivity; where you take time to look at some of your habits and plan to do better. Even though practices such as quality or compliance should be continuous activities, sometimes it feels right to use the new year as a “fresh start.” In this four-part blog series, I intend to discuss some key changes to the Quality Risk Management guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).<\/p>\n

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In industry, I would try to make it a beginning-year practice to look at any forward changing policies that could sneak up and derail the plans I had for my quality system. Of course, we all get surprises such as the 2020 guidance that was quickly publicized for testing requirements of nitrosamine impurities1<\/sup>, but long-planned change documents can also surprise those who don’t track the depth and breadth of all the regulatory body publications.<\/p>\n

Change is coming<\/strong><\/h3>\n

This year, the ICH is planning to release the final update for the Q9 Chapter on Quality Risk Management (QRM). We can expect this updated version in Q1 or Q2 of 20232<\/sup>; it has been in draft since November 2020. As a stroke of irony, the FDA called for manufacturers to adopt an enhanced risk management system3 <\/sup>in response to the infant formula supply crisis in 2022. So, with that in mind, there is a fresh responsibility to incorporate risk management into our quality systems, software and equipment.<\/p>\n

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Risk management, in general, is a systemic undertaking of examining a system for potential hazards and mitigating them with proactive tools and procedures.<\/p>\n

In the review4<\/sup> of the original publication, the ICH stated that “the benefits of QRM (quality risk management), as envisaged by ICH Q9, have not been fully realized…”<\/p>\n

They go on to define a list4<\/sup> of four areas of concern with current risk management programs that includes:<\/p>\n