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Exploring the Latest Changes in ICH Q9(R1) and their Impact on Quality Operations

Updated: Feb 13



The latest revision of Quality Risk Management ICH Q9(R1) launched in May 2023 introduces significant enhancements to quality risk management in the pharmaceutical industry. It bolsters risk management practices, advocating the principles and framework of ICH Q9.


This revision complements the recent publication of the European Union Eudralex - Volume 4 EU cGMPs Annex-1 for sterile medicinal products. Manufacturers are expected to comply with these revisions by August 2023. The revised Annex 1 fully embeds Quality Risk Management principles, providing clarity on leveraging new possibilities using innovative tools outlined in the guidelines of ICH Q9(R1) and ICH Q10.


Annex 1 encourages a risk-based approach during planning, execution, and reviews, focusing on the sterility of aseptic products. Proactive management of manufacturing processes and utilizing appropriate Risk Assessment tools for Root Cause Analysis and CAPA implementation are also stressed.





The ICH Q9 revision facilitates the ongoing process of manufacturers assessing and remediating identified gaps as part of their Compliance Action Plan. A notable addition in Q9R1 is the reference to official ICH training material, providing educational resources to facilitate risk management practices in the industry.


Q9R1 acknowledges subjectivity's impact on risk management activities and the need to manage it for effective risk management. It introduces the concept of managing risks related to product quality and availability.


Q9R1 introduces the term "pharmaceutical (medicinal) product" to align with industry terminology. It expands the scope of quality risk management to include distribution and emphasizes root cause analysis throughout the product life cycle.

The guide emphasizes product quality assurance through risk-based decision-making throughout the product life cycle. It recognizes the role of digitization in manufacturing and control. Platforms like iRisk, represented by Valgenesis, are mentioned as effective tools replacing manual processes and supporting knowledge and data integrity risk management.


The concept of formality in quality risk management is recognized, with Q9R1 discussing its role in risk-based decision-making. Q9R1 includes "inspection" as an aspect where quality risk management is applicable, emphasizing compliance with regulations, such as Annex 1 inspection requirements.


Q9R1 clarifies that "risk to quality" includes situations where product availability may be impacted, leading to harm to the patient. It defines "product development" as an interdisciplinary team responsible for managing quality risk activities.


Compliance with these guidelines is expected to be a collective effort of the pharmaceutical industry, regulatory agencies, and all stakeholders involved.


About the Author


Elizabeth Plaza, R. PH


Elizabeth-Plaza

Boasts over 35 years in the bio-pharmaceutical field, starting as a PD Scientist and later leading consulting ventures since 1993, focusing on compliance, project management, technology transfer and validation. Overseen 3000+ resources, completed 10000+ projects, including 1000+ in tech transfer & validation life cycle management. Currently leads a Third Party Consultant firm qualified as set forth in 21 CFR 211.34 to help establishments in meeting cGMP requirements. Co-authored PDA Technical Report #60 on Process Validation.



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