Liquid Compounding Procedure

1173 Words 5 Pages
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
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5.4.3.1 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).
5.4.3.2 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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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).
5.6.1 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).
5.7 The non-conforming batch must be adjusted as per the Process Batch Adjustment sheet
5.8 A sample must be taken from the blend.
5.8.1 The sample with the adjustments must be submitted to the Lab. Note that the sample must be accompanied with the Batch Card and Process Batch Adjustment sheet; otherwise, the sample will not be received for analysis.
5.8.2 The Lab conducts the appropriate analysis and
5.8.3 Releases the batch and the paperwork is attached to the liquid holding container(s).
5.8.4 Or requests further adjustments are made repeating the steps 5.5.4.2 trough 5.5.4.2.10 until the batch is released or rejected to MRB for donation or

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