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and at the frequency specified in writing by the manufacturer of the instrument and control
and released for use by the quality control unit
Developmental stability
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
6.0 - Production Overview batch record and at the frequency specifiedThere 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