General comments of the ISPE
The ISPE wrote several comments with recommendet changes, e.g. the general comment on page 2, in which the ISPE suggests that the basis of QRM activities is to be aware of the underlying risk, regardless of the formal level at which the risk exists. The ICH guideline states that the level of effort, formality and documentation of the QRM process should be commensurate with the risk.
Regarding the newly included concept of formality in QRM, the ISPE stated: „One of the stated objectives of ICH Q9 R1 is to expand on the concept of "formality" in Quality Risk Management. The Principles of Quality Risk Management (section 3) correctly states that "the level of effort, formality and documentation of the QRM process should be commensurate with the level of risk". Formality in Quality Risk Management (section 5.1) also correctly states that QRM is not binary (formal vs informal) but rather a continuum ranging from low to high. However, when the characteristics of risk assessments are described in lines 281 to 300, the impression of a binary system is given. High levels of formality are described as having a cross-functional team, use various QRM tools with all steps of the QRM process explicitly performed. By contrast the characteristics of lower formality are implied to always be imbedded and documented in other elements of the Quality System. ISPE considers that all Quality Risk Management exercises begin with the most informal of activities; that of asking a question. Questions are described in section 4.3 Risk Assessment […].“
Their proposed change is „ISPE believes that asking the initial fundamental 'risk question' is the foundation of all QRM activities, regardless of what level of formality is ultimately used. It is also believed that, depending on the initial answers, the process may end there with minimal or no documentatio […].“
Furthermore, the ISPE wrote "The section on formality gives the impression that informal risk assessments are always covered by a QMS/PQS procedure. This is not always the case e.g. equipment selection against CPP's/CAs, preliminary risk management exercise applied in the early phases of risk assessment when comparing proposed process steps using, for example preliminary hazard analysis tool."
They suggest that the principle of a proactive risk culture should be developed, recommending included guidance on a continuum from informal to formal risk assessment, which does not always have to be linked to a PQS element.
ECA Foundation and it's expert group, the European QP Assosiation (EQPA)
On page 23 the Foundation and its expert group published, among others, a comment on section 5.2, line 303 ff: "Effective risk-based decision making begins with determining the level of effort, formality and documentation that should be applied during the quality risk management process. The statement is not correct. "Effective risk-based decision making" is the result (the consequence) of the risk management effort."
They reason that effective risk-based decision making begins with determining the level of effort, formality and documentation that should be applied during the quality risk management process.
In the third step of the revision of ICH Guideline Q9, the comments are now being reviewed and further processed by ICH.
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