Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004?

[Stoic]

Yes, the FDA's Guidance for Industry - Process Validation: General principles and practices (2011) is for everyone except those accountable to CDRH, which still looks to GHTF/SG3/N99-10:2004 as the guidance document of record. Still, have any device companies found the 2011 FDA document more useful and applied its model, terminology, etc., in their quality system? If so, how did CDRH react?

 

[Tidge]

Yes, the FDA's Guidance for Industry - Process Validation: General principles and practices (2011) is for everyone except those accountable to CDRH, which still looks to GHTF/SG3/N99-10:2004 as the guidance document of record. Still, have any device companies found the 2011 FDA document more useful and applied its model, terminology, etc., in their quality system?

Absolutely not. My experience (medical devices) has been that when people try to apply the terminology from pharmaceutical process validations to processes used in medical device manufacturing and processing it only leads to trouble. It is best to accept that there are distinct vocabularies for the different industries and not try to implement a one-size-fits-all approach.

Edit: I do want to offer kudos for recognizing that there are distinct and different terminologies between the two industries and guidances. If my initial reaction seems exaggerated it is because I have spent uncounted hours interacting with folks at diverse levels trying to clear up misunderstandings and remediating wasted efforts because they did not recognize the differences.