Creating a Quality Attribute
- Jean Marie Schiraldi
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
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).
Open the Product tab
Create a new Quality Attribute
Name: Sialic Acid Content
Type: Chemical
Scope: Drug Substance
Category: Identity
Trace to TPP: Dosage Forms and Strengths
Click Save