1 reply to this topic

[mtelander]

Hello IFSQN family,

   I work in Quality for a dietary supplement contract manufacturer. We have an upcoming NSF/ANSI 455-2 Certification audit. I believe we are well prepared but would LOVE some feedback and tips for this audit that maybe we haven't thought of? Or things that you experienced in your audit with them?

 

Thank you!

[matthewcc]

Yes, there are a few things you should know about that, based on our experiences.  First, there are some requirements in 455-2 that go beyond what FDA requires.  For example, a master manufacturing record (MMR) written procedure is required, and an out-of-specification (OOS) written procedure is required, whereas the regulations themselves do not require that.  The auditor might ask for those, so I recommend having them ready.  Second, make sure your risk assessments and validation documents describe thoroughly why you chose the limits/procedures, etc. that you chose for your specifications, SOPs, etc.  The auditor can ask to review those as well.  They also follow up and review previous nonconformances at each certification audit.  To me, those are probably the most important examples of how 455-2 certification goes beyond merely complying with DS regulations in the US.