18th of February 2022

Revision of ICH Q9 (R1) Guideline on Quality Risk Management

Innovations in the implementation of risk management in the pharmaceutical industry: product availability, hazard identification, and attention to subjectivity in risk assessment.


Our GMP experts are experienced in risk management and will advise and support you in implementing all requirements of ICH Q9 (R1). First, however, we will give you an overview of the upcoming changes.

A draft revision of the ICH Q9 Guideline on Quality Risk Management (QRM) has been published in November 2021. Implementation in local regulations is planned for September 2022. This implementation by the European Commission means that it is binding for all European countries and thus will have an impact on the EU GMP Guideline, as ICH Q9 as GMP related document is included in part III of the regulatory framework for the manufacturing of medicinal products in the European Union.

As quality assurance systems have become increasingly important in the pharmaceutical industry, the requirements for quality risk management (QRM) must also be increasingly improved and expanded.

Therefore, in the course of the revision of ICH Q9, adaptations were developed for the following areas:

1. Risk Review

The existing text of the guideline has not changed with respect to risk review. Rather, revisions were made in connection with the development of additional training materials to better clarify the requirements.

2. Hazard identification

On the basis of term-specific corrections, it is proposed that the term risk identification will be replaced by the term hazard identification. Hazard identification is thus the first step in risk assessment. The identification and determination of risks is the first step, but must be followed by an assessment to categorize the hazard potential.

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3. Subjectivity in QRM

The draft revision states that subjectivity can have an impact on every stage of the QRM process, particularly hazard identification, estimation of probability of occurrence, and risk mitigation. Manufacturers should be made aware of the high degree of subjectivity in risk assessments and quality risk management activities.

The new version of ICH Q9 is less about banishing subjectivity but more about opening awareness to the presence of subjectivity including controlling and minimizing it through the proper use of QRM tools to facilitate scientific risk-based decision making.


4. Supply and Product availability

The unavailability of drugs, active ingredients or raw materials can represent a risk to the patient. This issue has not been sufficiently handled in ICH Q9. Quality and manufacturing issues, including noncompliance with Good Manufacturing Practice (GMP), can be causes of product shortages. An effective pharmaceutical quality system promotes both supply chain robustness and Good Manufacturing Practice compliance.

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Risk of drug unavailability for the patient.

5. Formalities in QRM

Although robust risk management should be the overarching goal of QRM, there may also be some flexibility in the extent of formality. How much formality should be applied to certain QRM activities and by what factors is formality influenced?

ICH Q9 (R1) concludes that less formality is acceptable for lower hazard levels. Whereas for a more complex and higher hazard potential a higher level of formality must be assumed.

For the scope of ICH Q9, this means:

On December 16th 2021, the draft revision was published for public consultation.

  • The principles and examples of the QRM tools are unchanged
  • They can further be applied to the processes and products throughout the pharmaceutical quality life cycle
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Risk management consultancy by Valicare.

If you need support implementing quality risk management in your company, we are ready for you! We advise and accompany you from the risk assessment, the evaluation to the implementation or update of your QRM.

We are happy to support you with the new requirements of the EU GMP Guideline Part 3!

Author: Dr. Annette Hogardt-Noll, GMP Consultant

Ellen Sons Brinkmann

First consultation free- contact us now!

Dr. Ellen Sons-Brinkmann
Tel: +49 69 153 293 709
Mail.: ellen.sons-brinkmann@valicare.com