specified substance
- Guideline or reference source
- ISO11238 IDMP Data elements and structures for the unique identification and exchange of regulated information on substances
- ISO11615 IDMP Data elements and structures for the unique identification and exchange of regulated medicinal product information
- ISO11616 IDMP Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
- Definition
- concept meant to provide elements to further specify substances or describe intermediate products and allow the capture of additional information that is essential to the description of materials in medicinal products NOTE 1 This additional information could include the grade, source, units of measure, physical form, constituents, manufacturer, and critical manufacturing processes. NOTE 2 Intermediate products are also described as specified substances. NOTE 3 Information needed to further specify a substance. This could include grade, units of measure, physical form, constituents, manufacturer, and critical manufacturing processes (i.e. extraction, synthetic, recombinant processes).
- Broader Term
- substance
- Narrower Term
- specified substance group 1
- specified substance group 2
- specified substance group 3
- Related Term
- component
- material
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