Pharmacutical batch reconciliation is a process which is used to calculate and monitor the process loss or yield of a product which is under manufacturing.
The purpose of the pharmaceutical reconciliation process is to ensure that all materials used for finished products have been correctly accounted for and no errors have occurred.
Calculation of yield or process loss is monitored during every stage of manufacturing to ensure that yield or process loss is within the recommended range. We know some process loss occurs during processing and handling and these losses must be within limits and accounted for.
Weigh or count intermediate, finished product after each significant stage and compare the actual weight (actual yield) with expected yield. The yield of product is indicator of well-defined and controlled process.
All pharmaceutical industries have an SOP which defines the final yield of a pharmaceutical product after packaging.
Atypical Template of Batch Reconciliation
During all manufacturing stages monitoring of yield or process loss gives us data to check the process efficiency and measures are taken to reduce the process loss and to increase the yield.
إرسال تعليق