Creating Process Records

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

  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

  1. Click Save Draft

  2. 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

  1. Click Save Draft

  2. 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

  1. 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

 

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.

 

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