Hello good people of the world! Today’s post is on what NOT to include in requalification/revalidation. I was recently on a site that had a five (5) year requalification requirement for sterilizers per a site SOP, which sounds reasonable (continuous monitoring would be better). But then I noted they included in their requalification requirements a re-execution of the entire initial controls system IOQ! The requalification included verification of:
- Hardware/software installation
- E-stop, guarding, and door interlocks
- Restart and recovery
- Recipe management
- Temperature, pressure, and time control
- Communication
- Security
And it was expected that this would be done every five years! It just so happened that in 2014 they paid a contractor to do the work, who sadly did not help the site out by letting them know the wastefulness of such an endeavor. This is an egregious example of resource misuse and not understanding the expectations of a validation program/taking a risk-based approach. The point of requalification/revalidation is to look for drift in processes, not blindly repeat testing already performed.
What misunderstanding-of-validation-expectation horror stories do you have? Comment below.
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