What ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management: Established Conditions and Post-Approval Changes requires
ICH Q12 requires pharmaceutical manufacturers to establish and maintain a pharmaceutical quality system…
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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: 9c2d010e6b80439e594b4e8f75a096b7bb6a23885c88bb438f638fbd4afadee3
Primary Citations — 5 traced to source
- ICH Q12, Article 1 - Pharmaceutical Quality System
- ICH Q12, Article 2 - Established Conditions
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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