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).
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).
Navigate to the Data tab
Drug Substances/Drug Products will be pre-selected
Raw Materials should be ignored; that is a legacy tab that existed prior to the implementation of Library Materials.
Raw Materials should be ignored; that is a legacy tab that existed prior to the implementation of Library Materials.
Choose “Add”
ID: BAT-001
Optional Fields:
Manufacture Date:
Release Date:
Expiration Date:
Scale:
Click “Save Draft”
Under Release, choose Generate Template and under Data Type select Final Attribute data (Single Lot/Batch)
Choose the Final Quality Attribute
QbDVision will generate and download an Excel template for populating
Populate the template with 3 or more measurements and save it
Import the Release Data template for the Batch record
Repeat Steps 4-9 to add another Batch record (use BAT-002) and choose different measurements for the FQA