CLEAN VALIDATED / POSTER
Cleaning validation is a lifecycle, not a one-off test
From process design through qualification to continued verification: this poster connects the evidence we generate with the decisions we make in routine operation.
READING THE POSTER
How the stages connect
Design begins with the products, equipment, residues and process conditions. This is where the cleaning approach, worst-case rationale and intended evidence are defined.
Qualification and validation test whether the defined process performs as intended. Sampling recovery, visible residue criteria and analytical acceptance criteria must be justified for the particular process and equipment.
Continued verification keeps the evidence current. Routine results, deviations, trends and relevant changes can prompt investigation, corrective action or reassessment of earlier assumptions.
Questions for your own programme
- Do routine monitoring and change control still reflect the equipment, products and cleaning process actually in use?
- Are sampling locations, recovery and analytical limits supported by evidence for their intended use?
- What finding or change would send the team back to process design or qualification?
Scope: This poster is an educational overview, not a universal GMP checklist or a substitute for site-specific risk assessment. Revalidation frequency and extent depend on documented change, performance and applicable requirements; the stages and examples shown are illustrative.