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 (Quality Risk Management) was published on 20th of January 2023, and updates the original guideline, which is now 18 years old. This guideline is intended to provide guidance on the principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging, and labelling materials in drug (medicinal) products, biological and biotechnological products).
The document provides important additional guidance on four specific areas:
- the levels of subjectivity in risk assessments and in QRM outputs,
- the product availability risks,
- the lack of understanding as to what constitutes formality in QRM work, and
- the lack of clarity on risk-based decision-making.
As stated in the guidelines, subjectivity can directly impact the effectiveness of risk management activities and the decisions made. While subjectivity cannot be eliminated from quality risk management activities, it may be controlled with the proper use of quality risk management tools and maximising the use of relevant data and sources of knowledge. An effective pharmaceutical quality system drives both supply chain robustness and sustainable GMP compliance. It also uses quality risk management and knowledge management to provide an early warning system. This includes an internal and external manufacturing process variation and state of control a robust facility infrastructure with suitable equipment and well-designed facilities the use of modern technology, such as digitalization, automation, isolation technology an effective monitoring strategy for supply chain partner performance. An understanding of formality in QRM can help to use resources more efficiently and can also support risk-based decision-making. This topic is addressed comprehensively, highlighting the fact that formality in quality risk management is not a binary concept (i.e. formal/informal), but includes varying degrees of formality. Those should be described within the quality system. When formal QRM is applied, it should be complemented with structured decision-making. In general, higher levels of formality require higher levels of structure. Still, there can be varying degrees of structure with regard to approaches for risk-based decision-making.