Is their someone kind enough to share labeling, packaging and preservation control procedure? I working for a start-up medical device company that requires a procedure how to control labels, packaging and perservation of contol... please advise!
A good procedure for label control would address the req's of 820.120, whereas ISO 13485 does not really specify much. Much of the additional controls are learned by experience, e.g. how to make sure you consistently print the correct shelf life on product, how to control prnted materials other than labels, segregation practices, etc.
Is their someone kind enough to share labeling, packaging and preservation control procedure? I working for a start-up medical device company that requires a procedure how to control labels, packaging and perservation of contol... please advise!
Maybe you will find some useful samples in the FDA's QSR manual, chapters 11 (labeling), 13 (packaging) and perhaps 14 (storage). Exhibits are at the end of each chapter.
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