VOMP 3011 – From URS to PQ – A Practical Validation Strategy
Topic-1: P&IDs (50%)
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
Topic-2: URS Matrix (20%)
- URS Matrix Instructions – VOMP3011 – Topic-2 File
- URS Matrix Spreadsheet File
Topic-3: PQ Testing (30%)
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
- Technical /Automation and Control
- Equipment Design
- Instrument Design