Pharmaceutical industry groups in the US suggested the International Council of Harmonization’s (ICH) Q9(R1) guideline on risk management be revised to better reflect the principles of the ICH Q10 guideline on effective quality management systems. Industry groups in the US and the Europe also recommended that forthcoming training materials provide more concrete examples showing how specific risk management principles can be applied.
These comments were in response to the US Food and Drug Administration’s (FDA) 15 June call for stakeholder feedback on the proposal. ICH published the Q9 revision at the start of the year.
The revision updates the original guideline, which is now 16 years old. The goal of the update is to provide “more scientific and robust applications of [quality risk management] QRM principles, tools, and activities,” leading to “fewer quality defects and recalls” and reduced costs for the pharmaceutical industry, according to an ICH Q9 business plan.
FDA received 19 public comments from stakeholders, and much of the positive feedback echoed the responses submitted to the European Medicines Agency (EMA) in early May 2022.
Groups express broad support
The Pharmaceutical Research and Manufacturers of America (PhRMA) said it “applauds” ICH and FDA’s “efforts to facilitate harmonized scientific and regulatory considerations for quality risk management (QRM).”
The European Compliance Academy (ECA) Foundation/European QP Association wrote that “the promotion of a science-based approach to risk management relying on knowledge management according to Q10 is really appreciated.”
The Association of Clinical Research Organizations (ACRO) also echoed their support for the revision. “ACRO is encouraged by and supportive of this draft guidance … The draft guidance does an excellent job of highlighting the core expectations and key operational process components of quality risk management.”
PhRMA and PDA want more emphasis on ICH Q10
But these groups also suggested several tweaks, including adding more references to the ICH Q10 guideline on effective quality management systems.
The current draft of the guideline states that “a proactive approach to quality risk management facilities continual improvements and is of strategic importance in achieving an effective pharmaceuticals quality system.” PhRMA suggested adding a sentence which references ICH Q10.
In a similar vein, the Parenteral Drug Association (PDA) suggested the guideline be modified to state that ICH Q10 as an “enabler” of QRM. “While it is true that QRM is a ‘valuable component’ of a PQS, consider using the language from ICH Q10” which states that Q10 is an enabler of Q9, the group wrote.
The current text states that “the importance of quality systems has been recognized in the pharmaceutical industry and is evidence that quality risk management is a valuable component of an effective quality system.”
PDA also suggested the upcoming revision define what is meant by the term “formality.” The guideline states that the higher the level of uncertainty of a given risk management activity, the higher the levels of formality in the quality risk management approach but does not define the term.
Training materials should clear up areas of uncertainty
Industry groups also said that forthcoming training materials on ICH Q9 provide more examples showing how certain principles and terms can be applied.
PhRMA, for example said examples should be provided illustrating what is meant by bias, formality in QRM, uncertainty in QRM, as well as examples showing how risk assessments can be used to reduce risk to the supply chains.
ECA also suggested that ICH training material provide examples illustrating subjective and objective QRM decisions, as well as an explanation of what science-based risk management effectively means.
ACRO: expand scope to include development
ACRO also suggested that the scope of the guidance be expanded to include the development process as well as manufacturing.
“There is general consensus within the industry that this guidance mostly applies to manufacturing, but the scope section clearly indicates that it also applies to the development process as well… We believe that this point should be strengthened and reiterated, that the guidance applies and supports the entire research and development process of pharmaceutical products.”
What to include in future updates
PhRMA also recommended that future ICH Q9 updates include advanced therapy medicinal products (ATMPs) and include clearer language on hazard identification.
The guideline defines hazard identification as “a systematic use of information to identify hazards referring to the risk question or problem description.”
PhRMA recommended the definition be revised to include that a risk analysis should also include a causality assessment, or an analysis of root cause failures.
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