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The revision of the ICH Q9 "Quality Risk Management" guidelines has been delayed for about three months due to the new crown epidemic, but the revision process is still advancing
.
Kevin O'Donnell, senior GMP inspector of the Irish Health Products Regulatory Authority, stated at the PDA/FDA joint regulatory meeting on September 30 that this will be a “very targeted revision
.
We will not modify many aspects of the guidelines.
According to the revised work plan, the main goal of the revision is to reduce the incidence of quality defects and recalls, thereby reducing the cost of the industry and the healthcare system
.
In addition, the revision will also address quality-related shortage indicators to prevent drug shortages
The work plan states that “the health and social costs associated with ineffective quality risk management (QRM) activities include serious quality defects (for example, lack of sterility assurance, contamination incidents, and product labeling errors) and possible harm caused by product shortages
.
In addition, more Well-designed production processes, more effective control strategies and verification activities, although these actions may not be able to solve the correct risks at present, they will improve financial efficiency
ICH may provide case studies and training materials by March or April 2022
.
Six themes
Six themesThe changes will focus on six themes:
Subjectivity in QRM
Product availability risk
Forms in QRM
Risk-based decision
Risk review
Hazard identification
Of these topics, five will be addressed by adding new chapters and training materials in Q9
.
Risk review topics may not write new content, but new training materials will be provided
O'Donnell said the revision would be "limited and specific"
.
The first four themes will be the main focus
Subjectivity in QRM
Subjectivity in QRM O'Donnell said that the current QRM assessment is highly subjective, which is problematic
.
"We know that we can control, and there are many peer-reviewed studies from other industries that tell us how to control subjectivity
Product availability risk
Product availability risk O'Donnell stated that ICH Q9 is not a supply chain guideline, but quality/production issues that affect product availability may pose risks to patients, and it is important to manage these risks
.
In essence, "product availability risk" can be understood as "a shortage of medicines
It is stated in the concept paper that ICH Q9 has already mentioned product availability risks, but “in view of the globalization, complexity and dispersion of the pharmaceutical supply chain (the number of participants)”, it is important to pay more attention
.
Forms in QRM
Forms in QRM O'Donnell stated that quite a few stakeholders said that they are not quite sure what the form in QRM actually means, which led to a revision of the term to clarify the term and training materials
.
The revised chapter will discuss the factors that need to be considered when determining how much to apply to a given QRM activity
Risk-based decision
Risk-based decision Like subjectivity, risk-based decision-making also has many peer-reviewed studies, and other industries such as nuclear power and aviation have also formulated risk-based decision-making guidelines
.
The revised Q9 will provide further guidance in this area and explain the expected benefits of pharmaceutical manufacturers if they invest in this process
.
Risk review
Risk review This topic will be the only topic that will receive additional training materials but will not revise the content
.
O'Donnell stated that the revision "will further clarify expectations related to the implementation of up-to-date risk assessment and risk review
.
" The risk review is also related to the ICH Q10 drug quality system and the concept of continuous improvement mentioned in the ICH Q12 drug life cycle management guidelines.
.
The concept paper also states that the revised Q9 may also benefit the development and increased use of data and emerging technologies
.
The application of QRM to the use of these methods may become increasingly important
.
Ultimately "everything in QRM will be transformed into risk-based decisions
.
"
He cited a sentence in the concept paper to summarize the motivation for the revision: "Recent quality defects (such as nitrosamines, contamination/cross-contamination during the introduction of new products or process changes) show that from process development to technology transfer, Pharmaceutical manufacturers need to adopt a more scientific approach to risk assessment and QRM activities, supplier approval, plant design, commercial production, well-managed changes and life cycle management
.
"
