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Transfer of QM Results To Batch Characteristics To Calculate Potency

1. The document describes the process of transferring QM inspection results to batch characteristics in order to automatically calculate potency for pharmaceutical batches. 2. It involves creating batch characteristics, assigning them to a batch class and material, then creating MICs linked to the characteristics to define loss on dry, assay, and a potency formula. 3. An inspection plan is made using the MICs, and entering inspection results will automatically calculate potency for the batch based on the defined formula.

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Arvind Sharma
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859 views7 pages

Transfer of QM Results To Batch Characteristics To Calculate Potency

1. The document describes the process of transferring QM inspection results to batch characteristics in order to automatically calculate potency for pharmaceutical batches. 2. It involves creating batch characteristics, assigning them to a batch class and material, then creating MICs linked to the characteristics to define loss on dry, assay, and a potency formula. 3. An inspection plan is made using the MICs, and entering inspection results will automatically calculate potency for the batch based on the defined formula.

Uploaded by

Arvind Sharma
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Transferring of QM Inspection results to Batch Characteristics to calculate

Potency
Every PP/QM consultant will get the requirement to calculate the Potency when they work for
Pharmaceutical projects, where Raw materials quantity for batch is depending on API. The process of
Raw Material Quantity calculation will be done through MQC (Material Quantity Calculation).

To Perform MQC, QM inspection results should be updated at Material batch level so Here will I am
going to explain step by step procedure to auto update the Inspection results value we have to
follow below Steps. These values will be updated once UD done.

1) Create Batch Characteristics

2) Assigning Batch Characteristics to Batch Class. (If there is no Batch class, We need to create
Batch Class through CL01 and need to assign Batch Characteristics)
Transferring of QM Inspection results to Batch Characteristics to calculate
Potency
3) Assigning Batch class to Material

4) Create MIC (LOD, Assay & Potency) with reference with Batch Characteristics
Transferring of QM Inspection results to Batch Characteristics to calculate
Potency
Transferring of QM Inspection results to Batch Characteristics to calculate
Potency
5) Create Inspection plan with Regular MIC as well as with Batch Characteristics MIC.

Once you enter Batch Characteristic MIC, System will ask for Formula since we select the
“CalC.formula” control indicator.

LOD value should be get from “LOSONDRY” MIC value. Since LOSONDRY is 0010 ietm in the
inspection plan so we have to enter C0010.

ASSAY value should get from “AN>ASSAY” MIC value. Since LOSONDRY is 0010 item in the inspection
plan so we have to enter C0020
Transferring of QM Inspection results to Batch Characteristics to calculate
Potency

Same as LOD and ASSAY, we have provided the formula for POTENCY Based on Business
requirement. Here Business follow below formula

Potency: (Assay-LOD)/10000

So we have to maintain according that in formula field for Potency


Transferring of QM Inspection results to Batch Characteristics to calculate
Potency
6) Create Purchase Order for the Material and do goods receipt

7) Do the results recording for the inspection lot

Here we have to enter the results for only Loss on Dry and Assay by HPLC. Based on values we
enter system automatically will calculate the results for remaining inspection characteristics.
Transferring of QM Inspection results to Batch Characteristics to calculate
Potency
8) Usage decision for inspection lot.

9) After Usage decision, Inspection results will be automatically updated in Batch. These values
can be seen in MSC3N.

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