Pharmaceutical Quality System¶
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (2008). Pharmaceutical Quality System.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Mechanisms¶
- Change Ledger
- Under formal change control, the change ledger opens an entry: the rationale (a second-source supply-risk mitigation), the supporting risk assessment
This sourceRequires a formal change-management system in which proposed changes record their rationale and receive quality-risk evaluation and relevant expert review for technical justification.
- Under formal change control, the change ledger opens an entry: the rationale (a second-source supply-risk mitigation), the supporting risk assessment
Verification¶
This reference passed the adversarial substantiation pipeline: it was checked to exist and to support the claim it is attached to. See how references were verified.
Registry ID ref:4c2816cafd2d · see in the full table