04 / Acceptance and handover
Prove the result under a representative production condition
Calculate boundary cases independently, seed changed and missing assays, and verify lot-specific factor, rounding, dose tolerance, approval, scale capability and finished-batch record. 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.