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6. Protect label identity through every batch change
Confirm which label belongs to each product and pack size, where the batch number and expiry information will be applied, and how their presence and legibility will be checked. Define line clearance, removal of previous-batch materials, label reconciliation where applicable, and documented release before restarting.
For US finished-drug manufacturing, 21 CFR 211.130 addresses packaging and labeling controls, including prevention of mix-ups and documented pre-use inspection. A bottle labeling machine applies labels; coding, vision inspection, serialization, aggregation and electronic records require their own specified hardware, software and verification scope.
7. Turn the URS into an acceptance plan
Write the User Requirements Specification (URS) before the configuration is frozen. Define what the equipment must do, how it will be cleaned and operated, and the evidence needed for acceptance. Assign responsibility for utilities, upstream and downstream interfaces, testing, deviations and document approval.
Factory Acceptance Testing (FAT) checks the agreed configuration at the supplier’s premises; Site Acceptance Testing (SAT) checks it after installation and integration. IQ documents installation against the approved specification, OQ checks operation across defined ranges, and PQ demonstrates performance under the intended production conditions. These activities support an agreed qualification and validation strategy; FAT alone does not validate the pharmaceutical manufacturing process. Use our รายการตรวจ FAT สายการเติม to prepare the equipment trial, with the manufacturer’s quality team approving the applicable qualification scope.
- Dosage form and formulation characteristics
- Packaging samples, drawings and tolerances
- Nominal dose or count and acceptance limits
- Required line output and batch schedule
- Contact materials and cleaning strategy
- Utilities, layout and environmental requirements
- Inspection, rejection and batch identification
- FAT/SAT, qualification support and deliverables