ICH adopts Q9 guidelines on quality risk management

The International Council for Harmonisation (ICH) has adopted a revised version of its Q9 guideline that aims to improve current quality risk management (QRM) programs by creating more objective risk assessments, which could potentially reduce quality defects as well as drug shortages.

The ICH Q9(R1) guideline was published on 20 January, and updates the original guideline, which is now 18 years old. It covers the principles of QRM, the general QRM process, risk management methodology, the integration of QRM into industry and regulatory operations. It also has two annexes addressing QRM methods and tools and another on potential applications for QRM.

The final guideline is little changed from the Step 2 draft published in December 2021. (RELATED: ICH releases revised Q9 guideline to improve risk assessments, Regulatory Focus 3 January 2022)

The adopted guideline introduces a new section on managing and minimizing subjectivity in section 5.4 on risk management methodology.

“While subjectivity cannot be completely eliminated from quality risk management activities, it may be controlled by addressing bias and assumptions, the proper use of quality risk management tools and maximizing the use of relevant data and sources of knowledge.” It also adds a reference to ICH Q10, Section 1.6.1 on addressing subjectivity.

By incorporating this revision, the document includes some of the comments on the step 2 guidance, where industry representatives suggested the version be revised to better reflect the principles of the ICH Q10 guideline on effective quality management systems. (RELATED: Pharmaceutical industry groups suggest modifications to ICH Q9 guideline, Regulatory Focus 19 July 2022).

The guideline also adds a factor in characterizing a company with a highly formal QRM system, stating such systems would involve the use of a facilitator, “with experience and knowledge of the quality risk management process” and that these facilitators “may be integral to a higher formality process.”

It also adds that for companies with a lower level of formality, a “cross functional team might not be necessary.”

The rationale for updating the 19-year-old ICH Q9 guidance was spelled out in both Q9 concept paper and business plan and the Q9 concept paper.

According to the business plan, the update aims to improve the current application of QRM across the pharmaceutical industry. The plan notes that “the health and social costs associated with ineffective QRM activities include the harms that can be caused by serious quality defects (such as a lack of sterility assurance, contamination incidents, and product labelling errors), as well as product shortages. Additionally, more effective QRM strategies would promote cost savings by reducing costs associated with quality defects and product recalls and the actions needed to address those.”

The concept paper stressed that the Q9(R1) document should create “less subjective risk assessments” which should lead to “fewer quality defects that could present risks to patients.”

ICH also announced an upcoming webinar on 26 January that will address ICH M11 on clinical electronic structured harmonized protocol (CeSHarP) and will be hosted by the Clinical Trials Transformation Initiative. The group also announced an updated ICH E2B(R3) Electronic Transaction of Individual Case Safety Reports training video on Module 1, as well as updated Q&As for version 2.4, which also reached Step 4.

ICH Q9(R1)

ICH adopts Q9 guidelines on quality risk management

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