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ASTM has published the revision of ASTM E3263 "Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing...
Data below the detection limit (DL) are known as left-censored data. Quite often, 100% of the results of the cleaning samples fall below the DL. How...
Two of the most commonly used terms used in pharmaceutical cleaning validation are the Maximum Allowable Carryover (MAC or MACO) and the Maximum Safe...
When cleaning sample results are below the detection limits (DLs) of an analytical method, these data are known as "non-detects" or...
The pharma industry has begun the movement to science-, risk-, and statistics-based approaches to cleaning process development and validation. Due to...