manufactured item
- Guideline or reference source
- EDQMST General principles and instructions for use of the list of standard terms
- ISO11239 IDMP Data elements and structures for the unique identificaiton and exchange of regulated information on pharmaceutical dose forms , units of presentation, routes of administration and packaging
- 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
- qualitative and quantitative composition of a product as contained in the packaging of the Medicinal Product NOTE 1 A Medicinal Product may contain one or more manufactured items. NOTE 2 In many instances the manufactured item is equal to the pharmaceutical product. However, there are instances where the manufactured item(s) undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal. NOTE 3 The manufactured item is not in direct contact with the outer packaging except where the outer packaging also serves as the immediate container.
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