Process Validation - OQ & PQ

[Pumie]

Can someone give ideas on how to conduct OQ and PQ validation for medical device packaging products.

 

[planB]

In case you are looking for validation of sterile barrier systems, refer to ISO 11607-1:2019 and ISO 11607-2:2019.

 

[chris1price]

For more general packaging, take a look at GHTF SG3, QMS - Process Validation Guidance. Its a little bit out of date, but a good starting point.

 

[humoor]

Hi we have perviously validated a sterile barrier for a tyvek pouch as per ISO 11609-2 2006, do we need to redo the validation as per the 2019 version? if nt the full revalidation what are the new updates that need to be consider.
Thanks!

 

[chris1price]

Its worth performing a gap assessment between the two versions and identifying any significant changes that pose a risk.

 

[humoor]

Thanks!