FDA draft guideline on ICH Q10

By Katrina Megget

- Last updated on GMT

Related tags: Quality management system

The US Food and Drug Administration (FDA) has released a draft
guideline document outlining a model for implementing the
International Conference on Harmonization's (ICH) Q10.

Referred to as Pharmaceutical Quality System, ICH Q10 incorporates the ICH Q7 Guideline "Good Manufacturing Practices (GMP)", and ISO Quality Management System Guidelines, while complementing ICH Q8 "Pharmaceutical Development" and ICH Q9 "Quality Risk Management". The guideline, which applies to pharmaceutical and biopharmaceutical drug substances and drug products throughout the product lifecycle, is in four parts focusing on: the pharmaceutical quality system definition; management responsibility; improvement of process performance and product quality; and improvement of the pharmaceutical quality system. The report stated: "ICH Q10 demonstrates industry and regulatory authorities' support of an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.""ICH Q10 thereby serves as a bridge between the regional requirements, helping industry and regulators achieve harmonization of the pharmaceutical quality system throughout the lifecycle of a product,"​ the report added. In terms of management responsibility, the document said senior management had the "ultimate responsibility"​ to ensure an effective pharmaceutical quality system is in place. This included establishing a quality policy, managing resources, establishing a communication process and reviewing the pharmaceutical quality system. The FDA draft also described four specific pharmaceutical quality system elements: process performance and product quality monitoring system; corrective action and preventative action system; change management system; and management review of process performance and product quality. Applying these, though they may already be required under regional GMP regulations, should help improve the process performance and product quality. "These elements should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognizing the differences among, and the different goals of each stage. Throughout the product lifecycle, companies should evaluate opportunities for innovative approaches to improve product quality,"​ the report said. The document described the goals of each product lifecycle stage - pharmaceutical development, technology transfer, manufacturing and product discontinuation - and gave examples of how each pharmaceutical quality system element was applied to that product lifecycle stage. The final section of the draft guidelines outlined the activities needed to improve the pharmaceutical quality system. These activities included management review of the pharmaceutical quality system, monitoring of the internal and external factors impacting the pharmaceutical quality system, and implementing the outcomes of the first two, such as making improvements and reallocating resources. ​ ICH Q10 is not intended to create any new expectations beyond current regulatory requirements.

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