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Creating a Quality Attribute

Creating a Quality Attribute

Owned by Jean Marie Schiraldi
Last updated: May 19, 2025

Overview

In this exercise, you will develop a Final Quality Attribute and link it back to a Target Product Profile (TPP) element. This connection to the TPP is what establishes the link between your Quality Target Product Profile (QTPP) and the TPP.

 

By tracing the Final Quality Attribute back to the TPP, you ensure that the quality attribute you are developing is in line with the overall goals and characteristics defined in the TPP. This alignment helps maintain focus on the desired product quality throughout the development process.

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. Open the Product tab

  3. Create a new Quality Attribute

  4. Name: Sialic Acid Content

    Type: Chemical

    Scope: Drug Substance

    Category: Identity

    Trace to TPP: Dosage Forms and Strengths

  5. Click Save

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