worst case
- Guideline or reference source
- ECA GAMP5 Approach and Risk Management
- FDASDP Sterile drug products produced by asceptic processing - CGMP
- Definition
- A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure.
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