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FDA's Q9 Guidance: Four Key Concepts to Remember

Four Key Concepts of New Risk-Management Guidance

Risk-based management is not just a buzzword. It's here to stay. In addition to the FDA's "Pharmaceutical Current Good Manufacturing Practices," which encourages risk-based methods, the agency has issued a new guidance on the subject.

The "Q9 Quality Risk Management" guidance offers a systematic approach to quality risk management. It outlines principles and examples of tools for risk management that can be applied to all aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, inspection, and submission/review processes throughout the lifecycle of drug substances, drug products, biological, and biotechnological products. It is meant to allow industry and regulators make more effective and consistent risk-based decisions.

The guidance, issued by the FDA in June 2006, was prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The group was formed to provide a forum for harmonization initiatives based on input from regulatory, industry, and consumer representatives. Its goal is to achieve harmonization of technical requirements for the registration of pharmaceutical products in the United States, the European Union, and Japan .

Here are a few key concepts you need to remember about risk management.

1. Risk Assessment: Consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. There are three basic questions to ask:

  • What might go wrong?
  • What is the likelihood it will go wrong?
  • What are the consequences?

2. Risk Control: Reducing the risk to an acceptable level. The amount of effort used for risk control should be proportional to the significance of the risk. Ask the following questions:

  • Is the risk above an acceptable level?
  • What can be done to reduce or eliminate risks?
  • What is the appropriate balance among benefits, risks, and resources?
  • Are new risks introduced as a result of the identified risks being controlled?

3. Risk Communication: The sharing of information about risk and risk management between the decision makers and others. Communication concerning quality risk management decisions between industry and regulatory authorities may be done through existing channels as specified in regulations and guidances.

4. Risk Review: Risk management should be an ongoing part of the quality management process. A mechanism to review or monitor events should be implemented.

Read more about the Q9 Guidance::

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Risk Management for Pharmaceutical Companies Under FDA?s Q9 Guidance



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