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Enter the item Revision , if the item is revision-controlled. Step 5: Put sample materials in storage packages and place them into variant storage conditions. Choose Calculate Sample Quantity from the Actions menu. Batches can be initial production batches for a new formulation, or a portion of routine production batches pulled for stability testing. Base Test Interval Plan as the name of the base test interval plan. Typically, the manufacturer of the drug substance has process impurity information either on the Certificate of Analysis or available on request. Click Item Spec.

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