Overview

In this exercise, we will walk through generating a template for importing Release Data, specifically a Single Lot/Batch for a Final Quality Attribute.

QbDVision also provides options to generate templates for Manufacturing Data, including Unit Operation Data (Single Lot/Batch) and Unit Operation Continuous Data (Single Lot/Batch). Lastly, QbDVision allows you to generate a template for a Cross Batch Import, which is a Single Attribute/Parameter Data (Multiple Lots/Batches).

Steps

1. Log in to your company’s Sandbox and navigate to an existing Project (this can be the project you created in a previous exercise or an existing practice project in your Sandbox).

2. Navigate to the Data tab

3. Drug Substances/Drug Products will be pre-selected

4. Choose “Add”

• ID: BAT-001

• Click “Save Draft”

5. Under Release, choose Generate Template and under Data Type select Final Attribute data (Single Lot/Batch)

6. Choose the Final Quality Attribute

7. QbDVision will generate and download an Excel template for populating

8. Populate the template with 3 or more measurements and save it

9. Import the Release Data template for the Batch record

10. Repeat Steps 4-9 to add another Batch record (use BAT-002) and choose different measurements for the FQA