Preferred Name | Control Strategy | |
Synonyms |
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Definitions |
A planned set of controls, derived from current product and process understanding that ensures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. |
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ID |
http://purl.obolibrary.org/obo/PROCO_0000290 |
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definition |
A planned set of controls, derived from current product and process understanding that ensures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. |
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definition source |
[ICH Q10] |
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label |
Control Strategy |
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prefixIRI |
PROCO:0000290 |
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prefLabel |
Control Strategy |
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subClassOf |
Delete | Mapping To | Ontology | Source |
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http://sweetontology.net/humanDecision/ControlStrategy | SWEET | LOOM |