ICH Q10
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 Q10 Quality System for Pharmaceuticals has two primary goals: to facilitate innovation and continual improvement through the product lifecycle, and to strengthen the link between pharmaceutical development and manufacturing activities.
Impact
This Quality System guideline applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle. The Q10 guideline will augment existing good manufacturing practices with modern quality system elements for pharmaceutical manufacturing, resulting in drug products that consistently meet quality specifications.
Challenge
The challenge facing the biopharmaceutical industry is how to streamline the regulatory compliance process – improving conformance to regulations & standards, yet reducing the cost of compliance activities. Currently, there are differences between industry and regulatory agencies globally, in interpreting quality system terms, principles, applications and expectations, creating a strong potential for even further disagreement. Companies using outdated methods for risk assessment, and those that do not conform to industry standards, face product recalls, negative impacts to patient safety, a reduction in time to market, and an inefficient allocation of resources. Implementing a new quality risk management system can be daunting, but it is necessary if the industry is implementing a culture of quality by design and continuous improvement.
The Dyadem Solution
Dyadem provides comprehensive Quality Risk Management solutions that enable global Biotech and Pharmaceutical companies to reduce risk management effort by 50%-80%. In addition to improved quality, compliance risks are reduced to avoid non-conformances. Dyadem provides the essential elements of the ICH Q10 Pharmaceutical Quality System: a lifecycle approach to all risk management related documents – linking documents through retirement of the product; real-time visibility to all quality & risk information; and knowledge management capabilities to facilitate continuous improvement.
Stature, an integrated web-based platform, unifies the quality management requirements of ICH Q9 and Q10. As a true enterprise solution it provides deep domain expertise in quality and risk management through localized consoles in the different areas of an organization. This allows the appropriate roles in your company to have access to real-time key performance indicators for accurate and rapid decision making. Its seamless integration of the various quality management best practices provides stakeholders with access to the collective knowledge from projects or business divisions across the company and its governance capabilities ensures compliance with internal and industry quality and risk standards.
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