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Labeling materials issued for a batch shall be carefully examined for identity and conformity to the labeling specified in the master or batch production records
EP or other recognised test methods
and at the frequency specified in writing by the manufacturer of the instrument and control
Methods requiring validation must be added to the VMP
Any production
6.0 - Production Overview batch record Labeling materials issued for aThere shall be written procedures for production and process control designed to assure that the drug products have the correct identity, strength, quality, and purity. These must be followed and documented at the time of performance. Any deviation from the written procedures shall be recorded and justified