commercial manufacturing process
- Guideline or reference source
- FDAPV Process Validation: General Principles and Practices
- Definition
- The manufacturing process resulting in commercial product (i.e., drug that is marketed, distributed, and sold or intended to be sold). For the purposes of this guidance, the term commercial manufacturing process does not include clinical trial or treatment IND material.
- Broader Term
- manufacturing process
- Related Term
- process design
- process qualification
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