What ICH Q13 - Continuous Manufacturing of Drug Substances and Drug Products: Regulatory Expectations, Control Strategy and Real-Time Release Testing requires
ICH Q13 requires pharmaceutical manufacturers to implement a control strategy for continuous manufacturing, as outlined in Section 3, and to conduct real-time release testing, as specified in Section 5.
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: e2028a9cc4076ffe55aec4cc4553f8bbab8fc2bfb93d0d5f2ee0e927b08edd85
Primary Citations — 6 traced to source
- ICH Q13, Section 3 - Control Strategy
- ICH Q13, Section 5 - Real-Time Release Testing
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