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¶
Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.
Does it back the claim? Not recorded. The single citation of this work carries no recorded support check.
Was it audited? Yes. A second, independent pass read the citation against the article text and recorded a verdict.
Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.
See how references were verified.
Registry ID ref:f4cf76bdc6e9 · see in the full table