Define dirty and clean hold times
Account for both pre-cleaning and post-cleaning storage intervals.
CV-REQ-000003
VISUAL GUIDE 01
Cleaning validation lifecycle
See how development, qualification and monitoring connect—and where change sends you back.
THE A3 FIELD POSTER
A process you can explain
Hold times, process variables and change triggers, connected in one evidence-led lifecycle.
- Five stages and their decisions
- Four cleaning variables to control
- Questions for product, equipment and result changes
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CLEAN VALIDATED / VISUAL GUIDE 01
Cleaning validation lifecycle
01
Design
Understand the residue, equipment and process. Define a cleaning procedure and the evidence it needs.
02
Qualify
Challenge the defined process. Evaluate the observations against justified acceptance criteria.
03
Monitor
Review routine performance. Investigate departures and assess the effect of changes.
A change or an unexpected result can send the programme back to an earlier question. The lifecycle is a connected review process, not a one-time checklist.
LEARNING OBJECTIVE
What this guide helps you explain
Explain the relationship between the evidence generated during development and the decisions made during routine use.