Master Batch Record. The Master Batch Record shall be reviewed and approved in writing by Patheon and by Client prior to commencement of Manufacturing Services. Any material change to an approved Master Batch Record shall be reviewed and approved in writing by Patheon and by Client prior to said change being implemented. Each batch of Product shall be manufactured by using a copy of the Master Batch Record. Each copy of the Master Batch Record for such batch of Product shall be assigned a unique batch number. Any deviation from the manufacturing process specified in the Master Batch Record must be documented in the batch record for that batch.
Appears in 2 contracts
Sources: Master Manufacturing Services Agreement (La Jolla Pharmaceutical Co), Master Manufacturing Services Agreement (Tetraphase Pharmaceuticals Inc)