Periodic Review of Validated Systems

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
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Dear all,

I am in the middle of a kind of philosophical discussion and would appreciate your thoughts.

The Periodic Review process, irrespectively of being review of equipments, computer systems, process control system, lab equipments, etc…, is it a quality process or not?

Because I would say that as any review, this falls under Quality processes as part of the QMS. I have some colleagues advocating that this should be and Engineering or Validation process, and therefore managed by those departments, but that does not suit well with me. I think that Engineering and Validation must participate in the review process, but should not have the ownership. We are doing quality reviews of the equipment state, therefore an independent review is needed.

Do you agree with this? Can you point me some industry guidelines, that can support my point?

Tks in advance

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"Risk assessment’ (see ISPE’s RAMPP or 'Risk Assessment for the Manufacturing of Pharmaceutical Products) of validated systems should be under the quality unit. In many cases the quality unit has a ‘Quality Engineering’ department that performs this task. See ICH guidelines Q8, Q9, and Q10.

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I agree with your thought that periodic review should be a quality process. Periodic review ensures system is maintaining its qualified state. Normally periodic review encompasses, user access review, review of change controls and current state of system vs documentary evidences. this is very much under provocative of what regulators look for and that’s why it’s a QA job.

Source: LinkedIn Group

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Ditto. Quality process as part of the QMS

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I agree that it is a quality activity.