Methods should really offer for comparing the impurity profile of each reworked batch versus batches manufactured because of the recognized approach. Exactly where schedule analytical approaches are inadequate to characterize the reworked batch, added strategies must be employed. T

Acceptance criteria for residues and the choice of cleansing treatments and cleansing brokers must be described and justified. There need to be a created and accepted contract or formal arrangement involving an organization and its contractors that defines in detail the GMP tasks,