Adding Acceptance Criteria to a Process Record
- Jean Marie Schiraldi
Overview
Acceptance criteria refer to the established standards or specifications that a product or process must meet in order to be considered acceptable for use or release. These criteria are typically based on regulatory requirements, quality standards, and scientific principles.
Acceptance criteria are crucial in ensuring the quality, safety, and efficacy of pharmaceutical products. They help to define the limits within which a product or process is considered to be in compliance with quality standards. Meeting acceptance criteria is essential for regulatory approval and for ensuring that products are consistently manufactured to meet quality requirements.
While this exercise focuses on adding acceptance criteria to a Process Parameter, the same steps can be used to add acceptance criteria to a Material Attribute, Intermediate Quality Attribute, or Intermediate Performance Attribute.
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 Process tab and click on an existing Process Parameter
See Creating Process Records if none exist
Click on the Process Parameter
Scroll down to Acceptance Criteria
Data Space: Control
Measure: Range
Group: Default
Label: Default
LSL: 100
Target: 200
USL: 300
Units: rpm
Click the checkmark that “sets” the record, and then choose Save Draft.
To add another piece of Acceptance Criteria, repeat steps 3 and 4.