Process revalidation periodic criteria

[Vinu Raghav]

Hi Experts,

Is there any packaging validation criteria for periodic revalidation?

According to ISO 11607-1;2019 section 9.3, 4 & 5, revalidation required only when the changes in existing process / validation
Is there any recommended timeline for revalidation, if there is no changes has been made in original process / validation?

Thanks in advance.

 

[Vinu Raghav]

is anyone wanted to share opinion on the above request?

 

[Tidge]

The nature of the validation(*1) and the process(*2) ought to inform periodic assessments and if necessary re-validation.

(*1) for example, if the validation was "retrospective", that is probably a good candidate. If the validation resulted in the establishment of control charts, a review of the output parameters may indicate that a re-validation may be in order (e.g. as tools wear).

(*2) some processes may be particularly "critical" in some sense, other processes may have "too much" variability in outputs that have been historically tolerated. If the resources exist to revalidate, I wouldn't keep with processes where improvement can be introduced.

 

[Vinu Raghav]

Thank you for your detailed information.

We recently gone through notified body audit, where the auditor were asking for packaging revalidation frequency.
Can we choose 5 years to revalidate again if there is no changes in packaging process/material.

 

[Tidge]

I don't know the details of what's being packaged, so I can't provide a definitive answer. If there are no concerns about sterility or contamination, and there are no customer issues deriving from packing... I'd be unlikely to ever considering revalidating packaging... in the absence of some sort of design change.

 

[planB]

Quote from ISO 11607:2019, section 9.4:

The need for revalidation shall be evaluated and recorded. If the situation does not require that all aspects of the original validation be repeated, this revalidation does not have to be as extensive as the initial validation.

This seems to be copied from the respective GHTF guidance on process validation, section 6.4, with the rationale given in section 6.3:

Various changes may occur in raw materials and/or processes, which are undetected, or considered at the time to be inconsequencial. (An example of this type of process is sterilization.) These changes may cumulatively affect the validation status of the process. Periodic revalidation should be considered for these types of processes.

Thus, a stringent change control system that detects and catches these "various changes" might serve as a rationale why you would not have to perform periodic packaging re-validations on e.g. an unchanged sealing process. Packaging stability and performance are typically only re-validated in case of changes to packaging characteristics that might adversely affect the initial validation.

Experimental periodic process re-validation is typically mandatory for sterilisation only.

@Vinu Raghav: you might ask your auditor for the specific requirement for periodic packaging re-validation.

HTH,