ICH Quality Risk Management Guidelines For Biopharmaceutical Manufacturing

By Rosario Hughes-Kielty

In the biotechnology industry, it is crucial to establish robust risk management plans in order to foster greater success and reduce the rate of failure. Quality Risk Management (QRM) principles have emerged as a pivotal strategy in achieving this objective. QRM involves a comprehensive evaluation of the risks associated with both patient safety and product quality, grounded in scientific knowledge, empirical data, and accumulated industry experience.

Regulatory authorities are placing increased emphasis on implementing a lifecycle approach, aligning with the principles outlined in the ICH Q9 guideline. This approach encompasses both formal and informal risk assessment tools, comprising risk assessment, control, review, communication of identified risks, and acceptance of residual risks.

The latest revision to the ICH Quality Risk Management guideline, effective as of July 26, 2023, aims to optimize efficiency, effectiveness, and scientifically grounded control strategies within the biotechnology industry. Here, we explore the key changes within these guidelines.