What ICH Q11: Development and Manufacture of Drug Substances: Design Space, Control Strategy and Manufacturing Process Development requires
This regulation requires drug manufacturers to establish a control strategy that includes design space, and to develop a manufacturing process that meets the requirements of ICH Q11, Article 1. According to Article 2, the control strategy should include a description of the manufacturing process and its associated risks.
Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use · Version: 1.0.1 · Last updated:
Primary source: https://www.ich.org/page/quality-guidelines
SHA-256 integrity: a0ed78bd18d545b02a3f3cb7b271adba670d3d0d16e7bb5c97aefbffbd4f5daf
Primary Citations — 10 traced to source
- ICH Q11, Article 1: Introduction
- ICH Q11, Article 2: Design Space
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