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Document flow

I.

Introduction

II.

Pre-requisites

III.

Configuration

IV.

Master data

V.

Process flow

I. Introduction:

Pharmaceutical compounds consist of pharmacologically active ingredient (API) and inactive


substance (excipients). Excipients are used as carriers for active ingredients; Pharmaceutical
compounds are administered in different dosage forms. Dosage forms are the means by which drug
molecules are delivered to sites of action within the body. These forms can be broadly classified as
solid dosage and liquid dosage forms based on the physical nature of the compound.
Dosage is a measured quantity of active substance to be administered.
For following needs dosage forms are required:
Accurate dose,
Placement of drugs within the body tissues,
Masking taste
Sustained release medication.
Dose is certain quantity of pure drug required to act on target site (molecule) or substance.
As Most of the API materials are synthetically manufactured they carry some proportions of
related compounds and carrier materials like water and solvents, that is physical quantity of
compound have proportions of active and carrier metals. For example, if compound is 99 % pure,

Created by Devidas Karad


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Material Quantity Calculation


--------------------------------------------------------------------------------------in 100 kgs of compound actual active material will be 99 kgs and remaining 1 kg would be a
mixture of relative and carrier compounds like water and solvents and this proportions will vary
from one batch to other batch. If tablets are manufactured based on the above example
considering only physical quantities, tablets will have lesser quantity of active ingredient which
may not be sufficient enough to act on the target molecule.
Since tablets or capsules are of fixed quantity, containing both active ingredient and excipient. Based
on the potency of the active ingredient, physical quantity or weighted quantity of the active
ingredient and excipients would be adjusted or balanced in such way that availability of the active
ingredient should be always equal to dose.
Calculations for balancing the weighted quantities of active and inactive ingredients could be
achieved automatically in SAP PP-PI module at release of process order by leveraging Active
ingredient management and Batch determination functionality.

Note:
I have taken a Scenario related to Pharma fill up process and planned value of 90 % Potency for
Active ingredient (In real Potency will be above 99 %) as a example and the process shown is upto
Material Quantity calculation in process order.

II. Pre-requisites :

Batch Specific Material Unit of Measurement


Classification of Material (Batch Class)
Batch Determination Rule
Bill of Material
Master Recipe

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Material Quantity Calculation


--------------------------------------------------------------------------------------III. Configuration:

Batch- Specific Material unit of Measurement: An alternative unit of measurement to define


conversion ratio specific to batch in the base unit of measurement.
Batch-specific Material units of measurement are:
Proportion unit
Product unit

Step 1

Define unit of measure for Batch specific unit of measure


SPRO > SAP Net weaver > General Settings > Check Units of Measurement > Unit of
Measurement (No Dimensions)
For the Demo purpose BKG was used as Batch-specific unit of Measurement

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Material Quantity Calculation


--------------------------------------------------------------------------------------Step 2
Activate use of Batch-Specific units of Measure
SPRO > Logistics General > Batch Management > Batch-Specific Material Units of Measure
> Activate Batch-Specific Material Units of Measure Select
Active Radio Button and save.

Step 3
Assignment of Batch-Specific units of measure to Reference units of measure
SPRO > Logistics General > Batch Management > Batch-Specific Material Units of Measure > Edit
Batch-Specific Material Units of Measure

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Material Quantity Calculation


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Step 4
Define Conversion between batch-specific units of measure and base unit of measure
1. i.e Definition of unit of measure for batch Characteristic:

Percentage: % = 1/100
Proportion Quantity from Base quantity
Base Quantity from Proportion Quantity

SPRO > Logistics General > Batch Management > Batch-Specific Material Units of Measure >
Calculate Proportional Factors > Define percentage Calculation

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Material Quantity Calculation


---------------------------------------------------------------------------------------

SPRO > Logistics General > Batch Management > Batch-Specific Material Units of Measure
> Calculate Proportional Factors > Define Calculation of Proportion Quantity from Base Quantity

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Material Quantity Calculation


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SPRO > Logistics General > Batch Management > Batch-Specific Material Units of Measure
> Calculate Proportional Factors > Define Calculation of Base Quantity from Proportion Quantity

1. IV. Master Data

Step 1

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Material Quantity Calculation


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Create batch characteristic for calculating proportion or product quantity.


Characteristic ZASSAY_ZYDUS created for the Demo

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Material Quantity Calculation


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Step 2
Assign the Characteristic to Batch Class

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Material Quantity Calculation


--------------------------------------------------------------------------------------Note: Characteristic can also be linked to Master Inspection Characteristic, when value is recorded
for MIC and valucated it will update the batch
characteristic

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Material Quantity Calculation


--------------------------------------------------------------------------------------ZASSAY_ZYDUS characteristic is assigned to Class PHARMA_BEST_PRACTICE Very Important:
Characteristics used for calculating proportion or product units should be assigned to special view S
within batch class. S view is assigned to Organizational areas field for the characteristic as shown in
the screen shot
Characteristics with S view are recognized during material master maintenance

Step 3
Assign the batch class to the Material in Classification view of material master record.

Step 4

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Material Quantity Calculation


--------------------------------------------------------------------------------------Assign characteristic in proportion /product unit in the additional data view in the Material master
record and specify the planned value as show in the screen shot below.

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Material Quantity Calculation


---------------------------------------------------------------------------------------

Planned value specifies the assumed ratio between batch-specific and base quantity in the
characteristic unit of measurement.
If the actual characteristic value of a batch is not known for a business transaction, system uses the
planned value from the material master.

Step 5
Create Bill of Material
Material 1733 (RM-A Material quantity calculation) is API
Material 1734 (RM-B Material quantity calculation) is excipient

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Material Quantity Calculation


--------------------------------------------------------------------------------------Above two materials are components in the BOM of 1735
Note: Batch-specific unit of measurement should be used in the field for unit of measurement for
the material 1733 for which proportional value is calculated.

Base quantity for the BOM is 200 kgs


Component quantity is 100 BKG for material 1733 (API)
Component quantity is 100 Kg for Material 1734 (Excipient)
Step 6
Create Master Recipe with production version and maintain the formula for Material quantity
calculation.
Note: Production version is Mandatory/ Prerequisite for Material quantity calculation.
From Material list of Recipe choose a/b system will lead to Material quantity Calculation screen.
Maintain the formula as shown in below graphic.

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Material Quantity Calculation


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MT stands for Material item OP stands


for Operation a/b formula is defined for
the material
CQSM stands for Quotient sum of Batch quantities or Characteristic values (Assay)
Please note in above graphic quantity of Material 1734 is shown as 88.889. This is because system as
calculated quantity based on the 90% potency of Material 1733.
Base quantity of Material 1733 with planned value of potency is 90 %
= (100/90)*100
= 111.111 kg
As per formula 200 111.111 = 88.889 kgs of Material 1734 is required.

Step 7
Create Batch determination Rule

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Material Quantity Calculation


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Note: For Batch determination to happen one have to maintain value 1 or 3 in Batch entry field of
MRP view 2 of Material master record of Component materials of BOM.

1. V. Process Flow Step 1

Create process order

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Material Quantity Calculation


---------------------------------------------------------------------------------------

Above graphic is before batch determination.


Step 2
Perform Batch determination by selecting the first component and clicking icon

Graphic after Batch determination

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Material Quantity Calculation


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Batch populated for the material 1733.

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Material Quantity Calculation


--------------------------------------------------------------------------------------Potency/assay is 100 % for the batch 466.

Step 3

Click on

Step 5

Click on execute icon

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Material Quantity Calculation


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System will re-calculate the quantities to accommodate the potency value from batch Note:
Quantity of Material 1734 is changed to 100 kg

Step 6
Perform Batch determination by selecting the Second component and clicking icon

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Material Quantity Calculation


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Material Quantity Calculation


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Batch number populated for the material 1734 in the process order Below Graphics show material
quantity calculation for Potency value of 95 %

Note: I have used same batch number 466 of material 1733 and
changed the value of Potency to 95 % in Batch master record and repeated the steps of Batch
determination.

Below graphic is before material quantity calculation

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Material Quantity Calculation


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Below Graphic after Material Quantity Calculation

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Note: Quantity of second component changed to 94.737 kg as per below calculation


(100/95)*100=105.263 is the quantity in base unit of measurement for material 1733

200-105.263= 94.737 kg is the adjusted quantity for the material 1734

Below graphic is after Batch determination of second component

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--------------------------------------------------------------------------------------Scenario 2:- Create process order

Quantity entered

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Material Quantity Calculation


--------------------------------------------------------------------------------------System calculates material quantity according to BOM

Batch determination was carried out for RJU100 material

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Material Quantity Calculation


--------------------------------------------------------------------------------------Formulas defined in master recipe/Process order under MQC tab

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Material Quantity Calculation


--------------------------------------------------------------------------------------Batch determination is carried out for RJU200

Click on Calculate product quantity and copy results

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--------------------------------------------------------------------------------------Quantities are copied

Product qty is changed

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Material Quantity Calculation


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Material Quantity Calculation


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Material Quantity Calculation


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Material Quantity Calculation


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