cleaning procedures validation
- Guideline or reference source
- HCGMP Canada GMP guidelines 2009
- Definition
- Testing of methods used to clean equipment/surfaces in a processing suite/facility with assays to validate the effectiveness of the cleaning. The use of “worst-case” cleaning challenges and the addition of a safety factor in the standard operating procedure can provide further assurance of acceptability. Such challenge might be created by artificially soiling a piece of equipment or by using reduced cleaning parameters (rinse time or volume).
- Related Term
- cleaning validation
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