bulk pharmaceuticals
- Guideline or reference source
- ECA GAMP5 Approach and Risk Management
- Definition
- Mean materials (both pharmacologically active and inactive) which are intended for use as a component of a drug or biological product. These include materials manufactured by processes such as: (1) chemical synthetics; (2) fermentation; (3) recombinant DNA or other biotechnology methods, (4) isolation/recovery from natural sources, or (5) any combination of these processes.
- Related Term
- bulk product
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