Creating Process Records
Overview
In QbDVision, the Process refers to the series of steps and activities involved in pharmaceutical manufacturing, specifically in a CMC (Chemistry, Manufacturing, and Controls) context. This includes defining the process components, materials, parameters, attributes, and quality/performance criteria necessary to ensure the production of high-quality pharmaceutical products.
Steps
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).
Add a Unit Operation to the Default Process by clicking the + sign next to Default Process
Name: Cell Culture
Click Save Draft
Add three separate Steps to the Production Culture Unit Operation by clicking the + sign next to the Unit Operation
Name: Sterilization and Media Preparation
Name: Inoculation and Culture Growth
Name: Sampling and Monitoring
Click Save Draft
Add a Process Parameter to the Cell Culture Unit Operation by clicking the + sign next to the Unit Operation
Name: Agitation Speed
Scroll down to Acceptance Criteria
Measure: Range
Click Save Draft
If you have access to another Project and Process, do the following steps:
Copy a Unit Operation from a different project/process
Click on the + next to Unit Operations
Choose from another project or process
Project: Select Project
Process: Select Process
Unit Operation: Select Unit Operation
Under the To section, the Project and Process will be pre-selected based on where you came from
Under Copy Options, you may
Choose the (new) Name: Unit Operation Name
Choose the Order: Previous Unit Operation
Click Copy and Add
At the end of this exercise, you should have one Unit Operation called Cell Culture with 3 Steps under it, a Process Parameter, and (if applicable) a copied Unit Operation from a different project.