6.0 - Production Overview batch record and released for use by

and released for use by the quality control unit

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

Methods requiring validation must be added to the VMP

containers

Any production

6.0 - Production Overview batch record and released for use byThere 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