HELPING THE OTHERS REALIZE THE ADVANTAGES OF PHARMACEUTICAL MANUFACTURING FORMULATIONS

Qualification: Action of proving and documenting that devices or ancillary methods are correctly put in, work appropriately, and truly bring about the expected benefits. Qualification is part of validation, but the individual qualification actions alone do not represent process validation.Ideal processes need to be in position to detect contaminati

APIs and intermediates should only be unveiled for distribution to third functions once they happen to be released by the standard device(s).Performance Qualification (PQ): documented verification that the gear and ancillary devices, as related jointly, can complete properly and reproducibly based upon the approved system strategy and specsProcessi