manufacturing process
- Guideline or reference source
- DIAEDM Guide to the DIA EDM reference model, process zone regulatory submissions
- Definition
- The process for manufacturing a finished drug product or any of the intermediates or raw materials required as a component of the drug product. All drugs manufactured for human consumption must comply with relevant manufacturing regulation and practice generally referred to GMP or Good Manufacturing Practice in the United States.
- Narrower Term
- commercial manufacturing process
- manufacturing step
- Related Term
- chemical development studies
- chemistry, manufacturing and controls
- manufacturing
- process qualification
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