Run a batch every year to revalidate the validated condition?


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Hi to everibody

I want to knoe if you run a batch every year to revalidated the validated condition?, a consultor has told me that this is part of conserve a validated state, it is true?

Thanks in advacce

Sergio ?vila

Ronen E

Problem Solver

Not necessarily true, it depends what the process is and what risks were identified in the initial validation.

I would say review and evaluate your situation annually. If nothing significant has changed and there are no indications of problems then just document the review and that's it. The review should include the risk management files.

Either way you should be doing what your SOPs say about it. If you change your practice, make sure to keep the SOPs aligned.



Every batch you run is a batch with your validated conditions. There is then no necessity for any annual event in the way you say. The more important aspect is to be sensitive to changes and then re-validate appropriately the changed situation at the right time. Never miss out the operator change as well.

Ronen E

Problem Solver
If the original validation already accounted for operators variability (as a process noise) then operators changes should not normally trigger re-validation. It's important to ascertain that any and all assumptions originally made regarding operators still hold, though.


Trusted Information Resource
211.180(e) requires that information and data about product quality and manufacturing experience be periodically reviewed to determine whether
any changes to the established process are warranted...

Process variability should be periodically assessed and monitoring adjusted accordingly.

We recommend that the quality unit meet periodically with production staff to evaluate data, discuss possible trends or undesirable process variation, and coordinate any correction or follow-up actions by production.

Data gathered during this stage might suggest ways to improve and/or optimize the process by altering some aspect of the process or product, such as the operating conditions (ranges and setpoints), process controls, component, or in-process material characteristics. A description of the
planned change, a well-justified rationale for the change, an implementation plan, and quality unit approval before implementation must be documented (? 211.100). Depending on how the proposed change might affect product quality, additional process design and process qualification activities could be warranted.19

the point is, regulations expect you to assess same periodically ( the frequencyand criteria shall suit the purpose of the product - process - etc)
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