Enabling Active Pharma Ingredients for Batch Balancing and Integration to SAP EWM.

Batch and its Classification system are two most potent weapons used in Chemical, Pharma or Medical life science industry to record the potency of a batch or technically called as Active Pharma Ingredients(API).

These material consist of one or more active ingredients, concentrates, carrier materials, or impurities, and so on. The potency of the active ingredients varies from batch to batch.

The active ingredient is the substance of greatest interest in the bill of materials, the proportion of which may vary from batch to batch. Therefore, during creation of a process order, the system must be able to select and adjust the batches needed to obtain the required amount of active ingredient.

Take an example of a drug hydroxychloroquine which is used as potent weapon to fight COVID-19.

This drug is manufactured  by using API, however, the Potency of this API material vary from batch to batch.  To map this kind of requirement in SAP ERP, SAP calls it as Material Quantity Calculation.

• The product quantity, that is, the base quantity of the master recipe or the order quantity of the process order.

This allows you to match up the product quantity with changed component quantities if, for example, a component is always consumed in batches.

Usually the Formulation of end product which is manufactured in fixed Batch sizes using a fixed quantity of API of a desired purity, for example 100%. However, in reality API would not always be available as per the desired purity and depending on its assay strength, the gross API quantity used to manufacture the formulation batch would vary

Header	      HCQ-01-A
Component	API-HCQ-01-A
Component	FILLER-COMP

How SAP can map this API manufacturing?

SAP has given 2 tools capture this concept.

1. Batch Specific Unit of Measurement
2. Material Quantity Calculation formula.

Maintain the conversion factor using Proportion unit using any planned value.

Create a Process order of Header product. The process in Pharma is calculate the filler quantity based on batch strength of API component. Use a formula required as per business need.

1. Taking an example of Potency as 100% of API component in Process order, and after need to conduct Material quantity calculation for batch balancing.

Carry out Batch Determination of API.

Conduct batch determination in Batch Specific UOM. KAI

Conduct Material Quantity calculation. MQC

Formula is copied maintained in Master Recipe.

The formula I used is CQSM: (Adding up Weighted Batch Quantities or Characteristic Values: Quotient Sum).

2) Change the Potency of Batch to 75% and create Process order with same header quantity.

Once potency of API batch is changed, the filler product automatically changes it value to keep the Header batch size as constant.

Now, for filler component needs to be issued is changed to new value.

This dynamic change of filler component based on Potency of API product gives Pharma drug manufacturers a leverage to dynamically calculate the issue quantity which is required to be staged and consumed in proportion quantity.

Integration to SAP EWM

Batch Specific UOM till now cannot be integrated to SAP EWM as of S/4 HANA 1909. However, SAP is supposed to release this functionality in 2021 as this already been raised by many customers in Customer Influence Program..

EWM is not prepared for batch-specific unit conversion because the batch information about proportion units / product units is not available in EWM. Beside the non-existence of the conversion data itself most of the unit conversions in EWM are done without knowledge about the batch.

Therefore units with a batch-specific unit conversion factor mustn’t be used in the warehouse.
They mustn’t be entered in any EWM dialogue.
They mustn’t be contained in any document which is sent to EWM / which is processed in EWM.

However, you can consult a SAP note: 2432414 – Materials / Products with batch-specific material units of measure. Using a Badi explained in the note, system can be modified to work in EWM enabled managed SLOC.

Below notes are available to look this restriction in all below versions.

• 2806070 – SAP S/4HANA 1909: Release information and restrictions for EWM in SAP S/4HANA.
• 2668150- SAP S/4HANA 1809: Release information and restrictions for EWM in SAP S/4HANA.
• 2494704- SAP S/4HANA 1709: Release information and restrictions for EWM in SAP S/4 HANA

If you want to learn how to write formula, go through below SAP Link. You need many sleepless nights to write a good formula as per business needs, there can be many permutations and combinations for API manufacturing.

https://help.sap.com/doc/saphelp_globext607_10/GLOBALIZATIONEXTENSIONS607/en-US/f9/dde7270c2011d396fb080009c17b92/content.htm?no_cache=true

The above testings is conducted in Demo system S/4 HANA 1709

Appreciate your reply to make this blog more productive and useful

Regards

Shailesh Mishra