Autoclave Validation Lifecycle

Autoclave Validation Dashboard

🔬 Autoclave Validation Lifecycle

GAMP 5 Approach to Qualification in Pharma

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6. Continuous Compliance & Revalidation

Validation is not a one-time event. The Autoclave requires ongoing **Revalidation** (typically annually/biennially) and **Routine Maintenance**. This ensures the process remains in a state of control as per **GMP** principles.

  • **Periodic Revalidation:** Confirms continued efficacy over time.
  • **Change Control:** Required for any major software or hardware modifications.
  • **Routine Calibration:** Mandatory scheduling for critical sensors (thermocouples, pressure gauges).