Batch Data
- Luke Guerrero
- Jean Marie Schiraldi
Table of Contents
Overview
QbDVision provides simple reporting capabilities to load and analyze Batch Record data and trends. The types of batch data that can be imported include Final Attributes, Unit Operations, Continuous Unit Operation data, and Single Attribute/Parameter data.
Key Concepts
Creating a Batch
The first step to loading batch data is to create a new Batch Data record by navigating to the Data tab from within your Project. Click the Add button, provide the required information, and click Save Draft.
Once saved, your draft Batch Data record will look like the one below. Notice the name is derived from the batch ID, but can be modified.
Generating a Template
Next, generate a template to load the necessary information. To create a template for a Single Attribute or Parameter, navigate to the Data tab of the Project and click Import > Single Attribute/Parameter Data. This will download the Excel template in which to enter batch data for a single attribute or parameter. Open the Excel template and populate the necessary data for the attribute or parameter, and then save the template.
Loading Batch Data
With the data entered in the template, the template is ready to be uploaded into your project. Navigate to the Data tab from within the Project. Click Import > Single Attribute/Parameter Data and select the appropriate template with the batch data to be loaded. Click Review Data, Next, and Import as Draft to complete the upload process.
Analyzing Batch Data
To analyze the trend for a given parameter, navigate to the Process tab. Using either the Tree or Table view, locate the appropriate record. In this case, record ID PP-3839. Open the record, scroll down to the Process Capability section, and click the View Analytics button to display the Analytics Dashboard.
To further analyze trends, click Control Charts to open the Control Charts. These charts can also be exported to various formats.
View Analytics
To view the Analytics Dashboard, a minimum of two Batch Data records for the respective attribute or parameter must be loaded in order to make comparisons and construct trends.
The Analytics dashboard can be accessed by clicking the Analytics icon in the Batch record or by using the View Analytics button in the Process Capability section of the record.
For more information about Data Analytics in QbDVision, see Process Analytics Documentation.
Frequently Asked Questions
Why does the Data tab show Raw Materials ( ) next to Drug Substances/Drug Products? Also, in the parentheses, I see numbers ranging from 0 and up. What do those mean?
Before QbDVision launched the Material Library in February 2023 (to the validated environment), all certificate of analysis (CoA) imports were done in the Data tab. If you see Raw Material (0), zero means no CoA imports are associated with the project. If you see a number >0, you can click on the Raw Materials tab and see the details of all the CoA imports for that project. For more information, see this Loom.
What’s the difference between importing Batch record data and importing COA records?
Loading Batch Data refers to entering information about a specific manufacturing batch into the system. This data typically includes details such as materials used, process parameters, quality attributes, and other relevant information specific to that batch. By loading batch data, users can track and monitor the progress of the batch throughout the manufacturing process.
Importing COA Records involves bringing the Certificate of Analysis (COA) records from external sources into QbDVision. COA records contain information about a specific product batch's quality and testing results. By importing COAs, users can compare the actual results of quality testing with the expected specifications, ensuring compliance with regulatory requirements and quality standards.
In summary, loading batch data involves inputting manufacturing-specific information into the system, while importing COA records involves incorporating quality testing results from external sources for analysis and comparison within QbDVision. Both processes are essential for maintaining product quality and compliance in pharmaceutical manufacturing.
Can QbDVision track and trend data when there are batch records and development work in the project?
Yes! You can create a batch record within the Data tab and upload your data. QbDVision provides basic Analytics reports like X-bar, R-bar, Capability, etc. See the screenshot below:
