ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System¶
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2008). ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System: Pharmaceutical Quality System.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Traceability
- Many organizations claim accountability, quality, or safety; traceability specifies the machinery that produces those claims as auditable facts rather than hopes—the framing that ICH Q10 (2008) embeds in its Pharmaceutical Quality System guideline as the basis for management responsibility and continual improvement.
This sourceICH. Specifies management responsibility, process performance and product quality monitoring, and continual improvement framework that converts pharmaceutical quality assertions into auditable, traceable facts.
- Many organizations claim accountability, quality, or safety; traceability specifies the machinery that produces those claims as auditable facts rather than hopes—the framing that ICH Q10 (2008) embeds in its Pharmaceutical Quality System guideline as the basis for management responsibility and continual improvement.
Verification¶
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