04 / Acceptance and handover
Prove the result under a representative production condition
Spike representative transfer material through new and conditioned routes, close active-component recovery, and verify compatibility, flush endpoint, carryover limit, replacement and monitoring rules. 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.