01/24/2023
Photo by Christine Sandu on Unsplash
The ICH Q9(R1) international guideline on Quality Risk Management reached step 4 on January 18, 2023. Step 4 is when the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Regulatory Members of the ICH Assembly have adopted the guideline as a harmonized guideline. Now ICH members implement the guideline within their applicable regulatory bodies. In the United States, ICH guidance are implemented as guidance and are not enforceable, but they often influence regulation development and additional FDA guidance document creation.
Applicable to drug quality, the guidance describes principles implementing quality risk management with a focus on change control and process improvement. Changes to the guidance include:
The step formerly known as ‘Risk Identification’ is now called ‘Hazard Identification’, although the process is not changed.
‘Risk Acceptance’ former definition included an active or passive decision to accept risk, but the R1 definition focuses on active, informed decision making to take a risk.
The addition of detection controls to reduce the probability of harm.
New sections on:
Formality in Quality Risk Management (QRM)
Risk Based Decision Making including a new definition
Managing and Minimizing Subjectivity
The role of Quality Risk Management in Addressing Product Availability Risks Arising from Quality/Manufacturing Issues
An effective quality risk management system ensures the quality of the drug by proactively identifying and mitigating risks during drug development, manufacturing, and distribution before they become issues. Part of an effective quality risk management system includes a thorough root cause analysis to manage issues.
- The Clinical Pathways Team
Enjoy this blog? Please like, comment, and share with your contacts.