· 9 min read
This first revision of Q9 was given Step 2 approval at the ICH meeting on November 18, 2021, and the Step 3 draft of this revision has now been published on the ICH website.
This revision is being made to address four areas for improvement with the application of QRM:
This revision has, quite rightly, taken the opportunity to change the terminology for the start of the risk assessment process from “risk identification” to “hazard identification.”
On subjectivity, the draft revision states that this can be introduced through:
It goes on to note, “While subjectivity cannot be eliminated from QRM activities, it may be controlled by addressing bias, the proper use of QRM tools and maximizing the use of relevant data and sources of knowledge.”
On formality, the new draft gives examples of the factors to be considered to determine the appropriate level of formality:
The draft then gives characteristics of higher and lower levels of formality.
There is a new section on risk-based decision-making. The new section states, “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.” It goes on to describe highly structured versus less structured processes, as well as rule-based processes when making risk-based decisions.
The guidance outlines the requirement for the development and implementation of a holistic, risk-based approach to visible particulate control that should start in product development and encompass manufacturing controls, visual inspection techniques, particulate identification and investigation, and corrective actions designed to assess, correct and prevent the risk of visible particulate contamination. The guidance also clarifies that meeting an applicable USP compendial standard alone is not generally sufficient for meeting the current Good Manufacturing Practice requirements for injectable products.
Key points from the new draft guidance that emphasize its focus on building in a risk-based quality control of particulates throughout a product's life cycle include the following:
Proactively addressing risk is an important part of a life-cycle approach to visible particulate control.
The European Medicines Agency (EMA) has published its Regulatory Science Research Needs initiative. The initiative has identified a list of almost 100 regulatory science topics that require further research to improve the development of medicinal products.
The EMA has divided the topics into four categories:
The initiative encourages researchers and funding organizations to consider the research agenda’s topics and share their findings with the European Medicines Agency.
Further information on the initiative can be found here.
NSF Health Sciences offers a pharmaceutical legislation update subscription service. The service provides you with 12 months of updates of changes to legislation and guidance that have the potential to impact the manufacture and distribution of medicinal/drug products. Full updates will be provided in February and September, with interim summaries in May and December. The updates will be provided as recordings through NSF’s online LMS portal and can be viewed at a time convenient to you. To grant access to the recorded updates, we will create an account for you on our LMS, and as each update is made available, you will receive an enrollment email with a link to view the material. There will also be an opportunity for Q&As with Pete Gough through two-hour live, virtual meetings each quarter.