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Quality Risk Management | ICH Q9 (R1)

ICH Q9 guideline describes systematic processes for the assessment, control, communication and review of quality risks and applies over product lifecycle: development, manufacturing and distribution.

The ICH Q9 Guideline has been revised to address the following:

  • The QRM principles and framework of ICH Q9 have been instrumental in introducing QRM approaches to both industry and regulators.
  • There are four areas for improvement with the current application of QRM:

    1. High levels of subjectivity in risk assessments and in QRM outputs
    2. Failing to adequately manage supply and product availability risks
    3. Lack of understanding as to what constitutes formality in QRM work
    4. Lack of clarity on risk-based decision-making

Guidance has been developed for each of these four areas; this new guidance has been inserted into various chapters and annexes of the current guideline. The new guidance will be supported by the development of official ICH training materials – these materials will include case studies to help illustrate the key points in the guidance.

This guideline provides 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.

Assessment of risk to quality should:

- Be based on scientific knowledge

- Link to the protection of the patient

- Extend over the lifecycle of the product

A model for quality risk management is outlined in the following diagram (Figure 1)

Risk assessment may start with the following questions:

1. What might go wrong?

2. What is the likelihood (probability) it will go wrong?

3. What are the consequences (severity)?

Hazard identification is a systematic use of information to identify hazards referring to the risk question or problem description. Information can include historical data, theoretical analysis, informed opinions, and the concerns ofstakeholders. Hazard identification addressesthe “What might go wrong?” question, including identifying the possible consequences. This provides the basis for further steps in the quality risk management process.

Risk control might focus on the following questions:

1. Is the risk above an acceptable level?

2. What can be done to reduce or eliminate risks?

3. What is the appropriate balance among benefits, risks and resources?

4. Are new risks introduced as a result of the identified risks being controlled?

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