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South Korean KFDA's KGMP Audit- Anyone with Firsthand Experience to share?

C

chloep17

#1
Has anyone had any first hand experience with an audit by the KFDA? We are trying to find information on costs involved and areas of the QMS that they may concentrate on.

Our distributor has advised that we, as the manufacturer, must cover half of the costs involved, is this normal?

Any information would be greatly appreciated.

Many thanks
 
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C

chloep17

#3
Thank you for your response.

Are you able to supply any requirements for the KGMP audit? Or an idea of costs involved?
 
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