Process Validation - OQ & PQ


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


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


Trusted Information Resource
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 Its a little bit out of date, but a good starting point.


Starting to get Involved
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.


Trusted Information Resource
Its worth performing a gap assessment between the two versions and identifying any significant changes that pose a risk.
Top Bottom