ISO 13485 Label Specifications and Artwork Control

T

theGrod

I need to create a work instruction for control of label specs and label artwork. Does anyone have an example they can share of how your company did this? This is new territory for me as my last company was not responsible for the development and maintenance of the labeling. Thanks
 

Ronen E

Problem Solver
Moderator
Courtesy of (the late) FDA QSR Manual:

This drafting and approval procedure is used to establish a uniform system for controlling the content of labeling and for approving labeling. This procedure is adaptable for use by any size manufacturer.
 

Attachments

  • Labeling control sample procedure.pdf
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O

oofforjebe

I need to develop a procedure on Label Artwork creation . Does any one have a sample procedure ?
Thanks
 
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