ICH Q9
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. ICH’s Q9 guidelines are optional; rather than a requirement, it is considered a resource document that should be used together with existing quality-related guidelines and legislation when a risk-based approach to pharmaceutical development is appropriate. ICH Q9 should be seen as supporting existing guidelines and complementing future developments in quality risk management practices.
Impact
This Quality Risk Management guideline can be applied to all aspects of pharmaceutical quality including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products, including the use of raw materials, solvents, packaging and labelling materials.
Challenge
Currently, there are inconsistent uses of risk management in determining appropriate quality requirements and industry practices around the world. The pharmaceutical industry is using risk management concepts, but there is no common understanding of terms, principles and application in these concepts, leading to increased potential for unacceptable items to make it to market, delays on product introductions, inefficient allocation of resources, and safe drugs mistakenly recalled from public use.
Companies may be reluctant to adopt new risk management systems, preferring instead to stick with an outdated, inefficient process for assessing and mitigating risk and quality issues. Since ICH Q9 compliance is not required, it may be difficult for quality engineers to convince management of the importance of investing in an efficient quality risk management program. Moving from a paper-based or static spreadsheet system for quality assessments to a more complex, integrated software system can be daunting.
The Dyadem Solution
The guidelines encourage organizations to effectively integrate risk management into the decision making process, directly affecting product quality and impact on the patient. Dyadem provides comprehensive Quality Risk Management (QRM) solutions that enable global pharmaceutical companies to reduce risk management effort by 50%-80%. In addition to improved quality and reduction in compliance risks, Dyadem also offers an integrated lifecycle model linking all parts of design and production risk analysis. This provides full traceability for FDA compliance and the identification of critical quality attributes to align design with manufacturing, making any pharmaceutical organization better able to follow the recommendations set out by the ICH Q9 guidelines. As a true enterprise solution Stature provides deep domain expertise in quality and risk management through localized consoles in the different areas of an organization, and unifies the quality management requirements of ICH Q9 and Q10 on an integrated web enterprise platform.
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