Master Batch Clause Samples

Master Batch process documentation will be prepared and approved by GalaGen as per its normal procedures. The Parties agree that deviations from master Batch process documentation may be necessary from time to time. Such deviations shall be discussed with Wyeth-Ayerst before any proposed shipment of the Ingredient. Individual Batch process documentation shall be photocopied from the approval master and issued for each Batch as per GalaGen's or its sub-contractor's routine system. Original Batch records will be filed securely by GalaGen or its sub-contractor. GalaGen or GalaGen's sub-contractor will perform all in-process control tests demanded by the approved Batch process.