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

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. Add a Unit Operation to the Default Process by clicking the + sign next to Default Process

• Name: Cell Culture

3. Click Save Draft

4. 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

5. Click Save Draft

6. 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

5. Click Save Draft

If you have access to another Project and Process, do the following steps:

1. Copy a Unit Operation from a different project/process

2. Click on the + next to Unit Operations

3. 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