Completing Technical Release Incoming Products

This Unit of the SAP Batch Release Hub for Life Sciences eLearning will focus on the different business scenarios and how they're executed in the system.

Flow chart with 3 different scenarios. Scenario one is called Technical Release with an additional text that is saying Incoming goods Bulk product Finished product. The second scenario is called Market Release and the third scenario Distribution Release. Both have the additional text Finished product. All scenarios have icons.

The objective is to get an understanding of use cases SAP Batch Release Hub for Life Sciences and where to embed it into the business architecture of the customer.

Within SAP Batch Release Hub for Life Sciences we are differentiating in three major business scenarios:

Technical Release
Market Release
Distribution Release

Technical releases can be performed for:

Drug substances (incoming goods)
Drug products (Solid / liquid bulk / semi-finished product)
Primary packaging
Finished products

The Market Release is performed for the finished product, that is, for a shipment from the production site to a distribution hub in a specific region.

The Distribution Release is eventually performed in the receiving regional warehouses for finished product batches and can be differentiated by, that is, country/region-specific release checks.

This section shows the technical background and data flow for the release of incoming good.

Initiate a Request for Purchasing

Enter the transaction ME21N to create the purchase order. Standard PO is already preselected and can be used for the example. Enter the standard supplier for all products/materials: USSU_LS001 SAP Batch Release Hub for Life Sciences.

Use the following organization data in the header:

Purch. Org.: 1710
Purch. Group: 001
Company Code: 1710

Screenshot of a SAP software interface from the Create Purchase Order app focusing on the fields Supplier, Purch. Org., Purch. Group and Company Code.

Three products have been created for external procurement with quality checks:

MZ-LS-3001 Fentanyl
MZ-LS-3002 Water for Injection
MZ-LS-3003 Sodium Chlorid

Screenshot of a SAP software interface from the Create Purchase Order app focusing on the rows Material, PO Quantity, Plant and Stor. Location.

For these materials, the quality management view of the material master data is maintained. Put in the PO-Quantity, the plant1710 and the storage location171A for each of the materials.

Only batch-managed materials are transferred to the SAP Batch Release Hub for Life Sciences. Internal batch number assignment is used for SAP Batch Release Hub for Life Sciences.

Select each material individually out of the line items and generate the batch by clicking the generate button.

In addition, the supplier batch number must be maintained manually.

Screenshot of a SAP software interface from the Create Purchase Order app focusing on the fields Batch, and Supplier Batch.

Deliver and Receive Goods (Inbound Logistics)

Enter the MIGO_GR transaction and enter the previously created purchase order number.

Screenshot of a SAP software interface from the Goods Receipt Purchase Order app focusing on the field with the Purchase Ordner Number.

Check all the line items as Item OK.

Save the goods receipt of the purchase order.

Screenshot of a SAP software interface from the Goods Receipt Purchase Order app focusing on the colm OK where all the checkboxes are checked.

QA02 - Change Inspection Lot

Individual inspection lots are created automatically for each material after saving the goods receipt.

Screenshot of a SAP software interface. The second screenshot is a pop-up window Set User Status. The options TEMP-Temparature checked and TRAN-Transport checked are selected.

Enter the inspection lot via transaction QA02 and select the inspection lots.

Select the user statusTEMP and TRAN to simulate release checks.

In a real-time situation, these checks would be performed in the external system and the manual selection of the status isn't necessary anymore.

In the tab Documents you can add the physical certificate to the inspection lot by choosing the + Button and adding the document type SQM and selecting the document 10000000002.

If the quality certificate is received via EDI the data will automatically be uploaded to the inspection lot.

Repeat the steps for the change inspection lot changes for the remaining materials.

QC51 - Record Quality Certificate Receipt

Enter the transaction QC51 to record the certificate receipt for the purchase order. The certificate receipt is maintained on line item level of the purchase order.

Note

If the PO consists of more than one line item, they must be selected individually after entering the PO.

Screenshot of a SAP software interface from the app Record Quality Certificate Receipt and a second screenshot that is showing a pop up window that shows a purchasing document.

Select the certificate status as received and enter the receipt date (today).

After setting this status, the certificate is recorded and the inspection lot status is changed to Certificate received.

Repeat these steps for all other line items.

Screenshot of a SAP software interface from the app Record Quality Certificate Receipt focusing on the fields Cert. Status and Receipt Date.

SAP Batch Release Hub Cockpit

On the batch release decision tab, two applications are visible: The Release Decision Overview and My Release Decision.

Screenshot of a SAP software interface focusing on two tiles with the apps Release Decision Overview and My Release Decisions.

The app Release Decision Overview shows in a single page the most important information and tasks related to the release decisions.

The information is displayed on a set of cards. This allows to focus on the most important KPIs and react to information quickly.

Screenshot of a SAP software interface showing different analysis charts.

The app My Release Decisions shows a worklist of all release decisions for the quality department that the user is assigned to. Click on the app icon to open the worklist of release decisions.

The compliance statuses of all batches assigned to your role are shown using traffic light indicators in the Release checks raw.

If the traffic light displayed is Green → It denotes that the release checks are Completed.
If the traffic light displayed is Red → It denotes that the release checks are Incomplete or Not compliant
If the traffic light displayed is Grey → it denotes that the release checks are pending.

Screenshot of a list with release decisions. The row Release Checks is highlighted with a red box.

In addition, the following information is also visible in this view:

Batch ID
Material ID and Material Description
Batch Location (Manufacturing plant)
Release Decision Trigger ID (Inspection Lot Number from SAP S/4HANA)
Release Decision Trigger Type
The release type: In this example only batches with release type Tech Release ext Procurement
Quality Departments
Due dates

Click on the item for the batch to be released to see the summary of the release checks.

Screenshot of a list with release decisions. The first column in the list is highlighted with a red box.

Release Check Summary

In the Release Check Summary tab all the release checks for the batch are shown in detail.

All checks can be done automatically by the SAP Batch Release Hub for Life Sciences hub, and therefore, for most of the checks you don't need to perform these checks manually anymore like in the older legacy process. SAP Batch Release Hub for Life Sciences Hub offers also the possibility to execute a manual custom release check as shown in the picture.

The pending release check can be finalized by selecting it out of the summary list.

Screenshot of a list with release checks. The header Release Check Summary and the list with the release checks are highlighted with a red box. .

In the release check window you must select the checklist item and complete it by clicking the button Complete Checklist item.

A pop-up opens and you've to select the Result of the check (okay; not okay; missing) and the Valuation (Compliant; Not Compliant; On Hold) from the drop-down menu.

Screenshot of a SAP software interface and a second screenshot named Complete Checklist item.

The manual release check is finalized by selecting the Change Status button.

In the Pop-Up window, choose the appropriate Status (Compliant; Not Compliant; On Hold) from the dropdown menu and enter a Comment for the status change.

After confirmation of the status changes the message "The release change status was successful" is shown.

Screenshot of a SAP software interface showing the Release Check app. In this Manual Release Check page the button Change Status is highlighted with a red box. The second screenshot shows what happens, when you click on the red button. A pop up window opens. You can change the Status and add a Comment.

Stock postings can either be automatically triggered by the customizing settings of the usage decision code in SAP S/4HANA or manually in the SAP Batch Release Hub for Life Sciences hub before setting the release decision.

Select the tab Stock Postings and press the button Set New Stock Posting Quantities.

In the Pop-Up window, choose the quantities to be posted to specific stock types (Unrestricted; Blocked; Scrap; Sample).

The technical release for the batch will be set by selecting the button Set Release Decision.

In the Pop-Up window, choose the appropriate Release Decision (Approved; Rejected) from the drop-down menu and enter your user password for confirmation.

Optionally you can enter a Comment for the release.

The Release Decision must comply with the Usage Decision Code in SAP S/4HANA to be able to set the usage decision for the inspection lot of the batch in SAP S/4HANA.

After clicking on the Confirm button the message "The release decision was set." is displayed.

The technical release of the batch is now completed and the system shows the following information:

the traffic light of the release checks are all Green
the release decision is Approved
the processing status is set to Completed

The information of the release decision is transferred to SAP S/4HANA and the usage decision is created automatically with the subsequent stock postings.

Especially in compliant working environments, signature logs have an important role to follow up and to distribute during, for example an audit.

Signature logs can be evaluated after the release in SAP Batch Release Hub for Life Sciences via the app View Signature Log.

Select the app View Signature Log in the tab Tracking of Changes.

The appropriate log can be found by using the Batch ID as a filter option.

QA13 - Display Usage Decision

The usage decision and the batch status change triggered by the previously release decision step in SAP Batch Release Hub for Life Sciences Hub can be checked via the QA13 (Display Usage Decision) in SAP S/4HANA.