2 replies to this topic

[mtelander]

Good afternoon, Quality SME's,

  Would anyone know if there is a specific regulation that requires an analytical lab to collect and review COC's for the gases used in the lab?

 

For context, we are a dietary supplement contract manufacturer and we have an on-site laboratory that uses gases for certain equipment. We recently had a customer audit where he stated that the regulations require us to collect and review the COC's of the gases to verify impurities and such? But my leadership is contesting that and i cant seem to find a reg that speaks to that specifically being a requirement

 

Thank you! 

[kfromNE]

Good afternoon, Quality SME's,

  Would anyone know if there is a specific regulation that requires an analytical lab to collect and review COC's for the gases used in the lab?

 

For context, we are a dietary supplement contract manufacturer and we have an on-site laboratory that uses gases for certain equipment. We recently had a customer audit where he stated that the regulations require us to collect and review the COC's of the gases to verify impurities and such? But my leadership is contesting that and i cant seem to find a reg that speaks to that specifically being a requirement

 

Thank you! 

 

You need to ask the customer auditor for the reference code. They can't state something and not know the code to back it up. 

[G M]

I can't think of regulations on the subject ~ but the GFSI schemes have some elements requiring compressed air and gasses be tested at point of use to make sure your compressor or air lines aren't contributing contamination.