ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Sections 12 and 13: validation and change control – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 12.3: Complete design, installation, operational and performance qualification of critical equipment and ancillary systems before process validation

What does 12.3 require?

Before process validation, critical equipment and its supporting systems should be qualified, usually through design qualification (the design suits the purpose), installation qualification (installed or modified equipment matches the approved design, manufacturer recommendations or user requirements), operational qualification (it performs as intended across the expected operating ranges) and performance qualification (connected equipment and systems perform effectively and reproducibly on the approved process and specifications), done individually or combined.

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Other controls in Sections 12 and 13: validation and change control – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.