04 / Acceptance and handover
Prove the result under a representative production condition
Prepare minimum and maximum doses, reconcile primary and diluted mass, measure uniformity and stability, and verify complete transfer, route heel, main-batch compatibility and hold limit. Challenge identity and sequence controls, verify scale and pump performance, reconcile containers and mass, and demonstrate blend uniformity or qualified finished-product assay. Put the sample or test material, method, instrument, production state, duration, limit, witnesses, retained record and deviation authority in the protocol before testing begins. Requalify when a product, package, site, speed or connected system invalidates the accepted basis.