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Principles of Quality Risk Management: Implementing ICH Q9

July 17th, 2014 by

ICH Q9 Risk ManagementAs you make efforts to adhere to guidelines and regulations created by diverse international bodies, you may find your firm pursuing numerous paths to compliance simultaneously. While there’s nothing wrong with taking specific approaches to each relevant quality risk management standard, devising an overall cohesive plan for compliance may be more efficient.

Following guidelines like ICH Q9 could improve your ability to ensure consistent quality throughout the research and development, manufacturing, distribution, submission and other critical stages of your product’s lifetime. Furthermore, the ICH Q9 initiative has been fully incorporated into the ISPE’s GAMP 5 recommendations for the risk-based validation of computerized systems in the pharmaceutical and medical device industries.

What Makes ICH Q9 Effective?

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was specifically formed to unify some of the pharmaceutical product regulations of Japan, Europe and the United States. ICH guidelines are effective benchmarks for those who want to market products internationally.

ICH Q9 was influenced by the FDA’s launch of Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach. This guideline addresses the management of risk to the patient based on scientific knowledge, the robustness of the QMS and the implementation of controls to risk management. FDA GxP regulations bear many close links to standards like ICH Q9 and ISO 13485, which has major impacts on medical device providers. As widely adopted standards, Q9’s suggestions have the potential to unify your quality risk management efforts.

Defining Your Quality Risk Management Needs

One notable aspect of ICH Q9 is that it identifies the responsibilities of those who perform quality risk management tasks. The standard maintains that interdisciplinary teams comprised of experts in numerous fields should take charge of organizing uniform quality management across their organization.

For many firms, this can present a problem. Without diversified workforces of their own, the efficacy of their compliance efforts may be called into question because they lack the experience to assess and handle field-specific risks. These organizations may find that working with independent consultants gives them access to the knowledge they need to improve their execution of quality risk management processes.

Third-parties may also be able to offer an impartial perspective that makes it easier to devise a more effective risk management road map.

Transitioning to ICH Q9 Compliance

What if your firm already adheres to ISO or FDA quality risk management standards? While you may feel that these guidelines’ close relationship to ICH Q9 gives you an edge over the competition, it’s still important to adopt a careful plan of attack for ensuring system compliance.

If you’re not diligent in planning your transition, you may miss out on a vital detail. Also remember that ICH Q9, like other guidelines, provides you with a lot of leeway for implementing risk management procedures. Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), Preliminary Hazard Analysis (PHA) and numerous other tools are all identified by Q9 documentation as being potentially appropriate for managing risk.

The standard also notes that such implementations may have to be adapted, meaning that your firm must take the appropriate steps to ensure they’re used effectively. For organizations attempting to manage risk within supply chains and other critical systems, it’s important to apply a custom ICH Q9-based strategy instead of trying to work with a suboptimal, generic solution.

Quality risk management must be tailored to the needs of your firm. GxP-CC consultants are well-versed in creating adaptable ICH Q9 and FDA GMP implementations. To learn more about improving your risk management strategies, contact these multidisciplinary consultants soon.

About this author:

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For over 15 years Mr. Francum has worked in regulated environments directing and orchestrating the various components involved in assuring compliance of the most stringent regulatory requirements. He is an internationally recognized expert and has extensive experience in over 25 countries including, but not limited to, the regions of North America, Latin America, Europe and the Middle East.

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