Active Ingredients Management And Material Quantity Calculation in Process Industry

[dhaval_choksi3]

Hi All,

Purpose of this document is to share how Active Ingredient Management is handled in SAP and more specifically in process industry scenario. Document will also illustrate how we can leverage Standard SAP functionalities of Bach specific unit of measure and Material quantity calculation to achieve one of the most complex business scenario of pharma industry.

Some of the key highlights of this two functionalities are,

Active ingredient management (Batch Specific UoM)

1. Provides ability to maintain theoretical potency per material.


2. Provides ability to maintain actual potency per material batch.


3. Provides ability to automatically ‘exponentially’ convert material batch specific dimensional units of measure to doses based on ‘potency’ of the batch.


4. Provides enterprise wide material batch inventory visibility in doses and in dimensional units


5. Process order, provides ability to automatically determine active ingredient batches based on  sort rule (e.g. FEFO, FIFO etc.), component requirement quantity needs to automatically adjust based on potency of the batch.

Material Quantity Calculation

1. Provides ability to execute Quantity balancing to automatically adjust excipient (filler ) material quantity requirements, based on quantity picked of active ingredient material batch.

In this document i am not going into details like prerequisites and master data , as lot of information is available online, the main purpose of this document is to just give you a demo how this functionality works in a scenario where Process order quantity adjusted automatically based on quantity picked of a batch of Active pharma Ingredient.

For this demo, i am taking a scenario of Dry Powder Injection, its a pharmaceutical product. Scenario of this product is very much different than other Pharma Products e.g Tablet, Capsule.

• Batch size is not fix in  dry powder injection products


• BOM components are mostly limited to one raw material only,


• There is no major processing involved. Raw Material is filled directly into Glass vial in specific quantity (e.g. 1 gram, 2 gram etc)  under control environment,

This filling quantity may very depend upon the potency (active %) of the Active Pharma Ingredient. Most of the times Available Batch quantity of a raw materials decides the batch size of the product.

Now lets quickly move forward and see how this two functionalities can help in this kind of product scenario.

  Process order is created of 92500 Qty.

  Component details, required quantity of a Active ingredients is Maintained in unit KAI, which is a        Batch specific unit of Measure.

 

Performing Manual Batch determination of a Active Ingredient.

   Instead of required quantity of 92.5 (KAI), i have picked total available quantity, which is 119.9 KAI      in  KG this quantity will be different which we will see later in this document.

Now instead of 92.5 KAI, i have picked full batch quantity, which is 119.900 KAI, hence my order quantity should also change accordingly, here material quantity calculation will help to change this Process order quantity automatically.

Now go to Material quantity calculation tab, i have assign a formula to calculate the product quantity, based on the raw material quantity picked.  for more information on how to define formula refer below links.

On pressing calculate product qty, process order quantity will change automatically.

Now Let us understand how Active ingredient management (Batch Specific unit of measure) has helped in this scenario

In above case raw material quantity picked was 119.900 KAI, which is in Batch specific unit of measure,  however quantity in Base unit (KG ) is higher than 119.900, as its batch potency is 92.9585 % only, which means if you pick 1 KG from this batch then you will get only 0.9296 KG of pure active material.

 

Quantity conversion between KG and KAI

Here Potency of a batch is 92.9585%, hence instead of 1 GM i have to fill 1.0757 GM in a Vial so that at the time of usage, patient will get 1 GM 100% potent drug.

In Above scenario i have demonstrated a scenario where Product Quantity (process Order quantity ) is changed automatically with help of Material Quantity Calculation and Batch Specific Unit Of measure.You can use this functionality to,

1. Auto adjust required quantity of other BOM component in a process order, based on the quantity picked of a Active Ingredient, in pharma this component is mostly referred as filler material.


2. To auto calculate operation/phase quantity of a process order, depend upon quantity picked of a specific material.

________________________________________________________________________________

For more information on how to define formula refer below links.

https://help.sap.com/saphelp_globext607_10/helpdata/en/f9/dde7270c2011d396fb080009c17b92/content.htm...

https://help.sap.com/saphelp_globext607_10/helpdata/en/f9/dde7330c2011d396fb080009c17b92/content.htm...

Kindly share your feedback/inputs to make this document for useful.

Dhaval