Abstract: Novo Nordisk PI upgrade

This presentation will give an overview and dives into details on a complete PI System upgrade in a pharmaceutical company.

Based on an upgrade/qualification executed at Novo Nordisk production site, the used methodology is explained.


• PI setup in general
• Benefits Validation Concept/Production Implementation/Business

• The V-Model explained

• Qualification in general
o Flow for qualification
• Qualification in general –adherence
o Good Manufacturing Practice (GMP)
o Good Automated Manufacturing Practice (GAMP)

• Qualification concept
o Why
o How
o Important
o Roles and responsibilities

• Preparing the Qualification

• Qualification – Implementation and Execution
o Installation Qualification (IQ)
o Functional Qualification (OQ)
o Performance Qualification (PQ)

• Release for production…
o Pre-conditions
o Maintain the validation state…