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