ICH Q11 is a guideline developed by the International Council for Harmonization (ICH) that focuses on the development and manufacturing of drug substances, including both chemical entities and biotechnological/biological products. It provides a framework for understanding and controlling the manufacturing processes, emphasizing the selection and justification of starting materials, process development, and the establishment of a control strategy to ensure consistent product quality.

What does ICH Q11 promote?

ICH Q11 promotes systematic approach to drug substance development, integrating principles of Quality by Design (QbD) to enhance product quality and regulatory compliance throughout the product lifecycle.