specified substance group 2
- Guideline or reference source
- ISO11238 IDMP Data elements and structures for the unique identification and exchange of regulated information on substances
- Definition
- Refers to the manufacturer of either a substance or a specified substance Group 1, along with minimal manufacturing information. The minimal manufacturing information can include the overall production method type (e.g. synthetic, extractive, recombinant) production system type (e.g. cell line, plant or animal tissue), production system (specific cell line). NOTE: Group 2 elements allow for the tracking of the substance to the manufacturer. This is important for substances in biosimilar or other generic products. It also allows the distinguishing of synthetic peptides from recombinant peptides and the capture of the product cell line.
- Broader Term
- specified substance
- Related Term
- specified substance group 1
- specified substance group 3
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