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Qualification: Action of proving and documenting that equipment or ancillary devices are correctly mounted, function effectively, and truly result in the anticipated outcomes. Qualification is an element of validation, but the individual qualification techniques alone do not constitute method validation.Continuation of a procedure step right after

Harvest and purification strategies that take away cells, cellular debris and media components although protecting the intermediate or API from contamination (notably of a microbiological nature) and from loss of high qualityAcceptance criteria for residues and the choice of cleaning techniques and cleansing agents should be defined and justified.P