MHRA has released a new guidance document related to 'GXP' Data Integrity

planB

planB

Super Moderator
dgrainger,

in my experience, pharmaceutical guidelines do become relevant for medical-device manufacturers when either specific medical-device standards are missing or when medical-device standards explicitly refer to pharmaceutical guidelines. Some examples for the latter:

  • endotoxin testing and other microbiological-quality tests for medical devices are typically performed per pharmacopendial methods
  • biocompatibility tests for medical devices are typically performed as GLP studies
  • software validation in the medical device area typically follows GxP concepts
In this way, I would regard this guidance document as being relevant for medical device manufacturers.

My 2 cents,

Gerhard
 
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