Process Validation - OQ & PQ

P

Pumie

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

planB

Super Moderator
In case you are looking for validation of sterile barrier systems, refer to ISO 11607-1:2019 and ISO 11607-2:2019.
 
chris1price

chris1price

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 Its a little bit out of date, but a good starting point.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