Liquid Compounding Process

1.0 PURPOSE: To implement a process that will ensure that non-conforming batches will go through the correct process and procedure for correction/adjustment and that all documentation and subsequent batch releases are issued to the work order for filling. This procedure will also eliminate accretion of previous blends in the liquid compounding area.

2.0 SCOPE: This procedure applies to the Liquid Compounding, Pre-weigh area and Lab. 3.0 RESPONSIBILITY: It is the responsibility of the Compounding Manager, Compounding Lead and Compounding associate, Scheduling Clerk, Pre-weigh Manager, Pre-weigh associates, Lab Manager and Lab Technicians to follow this procedure.

4.0 PERSONAL PROTECTIVE EQUIPMENT: Protective eye glasses, gloves and hair
…show more content… Once the components are brought from the Pre-weigh area for batching, the compounder assigned the batch must verify the chemicals and quantities brought from the Pre-weigh department and the weigh tickets must be affixed to the back of the Work Order (do not throw away). If there are any missing tickets stop the process and notify your supervisor for prompt follow-up, you may resume once the ticket and chemical is verified (this is an urgent matter and must be addressed immediately by informing the Pre-weigh department manger/supervisor and frequently seeking updates to keep as high priority).
5.4.4 The compounder assigned the batch must verify that the tank condition and cleanliness (in the case of micro sensitive products the Lab must be notified for inspection), verify that the scale is zeroed (tare), pipes are setup properly and all clamps are tight to prevent product leaks or air introduction into the blend, and that the tank discharge valve is in the closed position prior to batch preparation.
5.4.5 The batch is then prepared as per the Batch Card
5.4.6 A sample of the blend must be taken to the Lab once
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Revision Date Requested By Why Revised
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Please select if true or false

Any requests for adjustments by the Lab are made to the batch by completing an In Process Batch Adjustment

a) True
b) False

The Process Batch Adjustments contains the following information: adjustments needed, including: Product made, batch number, batch size, W.O. Number, Item number, tank number, Item(s) needed, description, amount needed, procedure steps such as mixing times etc., additional comments and who issued the adjustment date and time

a) True
b) False

After and adjustment is made following the In process Batch Adjustment s made, the sample with the adjustments is submitted to the Lab and it is accompanied by the Batch Card and Process Batch Adjustment sheet; otherwise, the sample will not be received for

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