VOMP 3011 – From URS to PQ – A Practical Validation Strategy

This module is fundamentally a workshop module where you will apply all the material you have
learnt over the previous five online modules.

The objective is to generate a high-level user requirement specification based on P&ID requirements, and subsequently to develop suitable performance tests traceable to these specifications.

Sketch out your own P&IDs based on the four descriptors:

• P&ID-1: Bioreactor
• P&ID-2: Antifoam Tank
• P&ID-3: CIP
• P&ID-4: Media Sterilizing

• Session-1 – Process-1 – Bioreactor – Rev 005File
• Session-1 – Process-2 – Antifoam Tank – Rev 004File
• Session-1 – Process-3 – CIP – Rev 004File
• Session-1 – Process-4 – Media Sterilizing – Rev 004File

• URS Matrix Instructions – VOMP3011 – Topic-2 File
• URS Matrix Spreadsheet File

Select three (3), or more, of your high level ‘Performance Requirements’ from your URS matrix, and develop three (3) associated PQ tests using the ‘Minimum Elements of a Test Script’ template.

Integrate into each of the three tests as many of your additional requirements as possible from under the following headings in the URS matrix:

• Operational Process Requirements
• Functions
• Technical /Automation and Control
• Interfaces
• Environment
• Equipment Design
• Instrument Design
• Constraints