🔬 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).