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Label work instruction - Medical Devices

#1
Hi All

New to the site and new to the world of medical devices as first job in this big world of production and manufacturing.

My new role as a QC person in a new start up company is to figure out how to present a work instruction for generating and printing labels for attachment to our product class 1 and class 2 med device.

I'm really struggling with getting a document together for work instructions, even though I have drafted an overarching SOP for control of labeling (per fda and eu Reg requirements). I've tried asking my QA manager and Reg Affairs manager (there are no QA/Reg Affairs specialists) however they are too busy to deal with daily activities so I've been tasked to try to put something together.

Can anyone advise me on how best to approach this? Okay i get there is the usual Purpose, scope, references, definitions/abbreviations/ responsibilities sections needed following by the procedure section. However what I'm not 100% sure of is how to map out the label work instruction wrt to label sizing/content on label/ etc.

Has anyone got a template or example I can look at as I'm really getting confused reading all the literature and not getting anywhere fast.

Many thanks!

Franklin
 
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yodon

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#2
My approach for label sizing, content, etc. is to have a "label specification" to cover what's required and then label artwork for the exact label representation. This is not a required approach but I've found it useful. The point is that for sizing and content, I focus on the label, not a work instruction.

In production, there are work instructions for labeling operations (proper setup of labeling equipment, verification, etc.). If you are intending to distribute in the US, the FDA has some specific requirements, including "The label and labeling used for each production unit, lot, or batch shall be documented in the DHR." I've typically seen this accomplished through printing the first (and sometimes last) labels and putting the physical label in the DHR. I've also seen just a scanned image of the label put in the DHR. Label reconciliation (knowing exactly what's been printed) is a really good idea (and helps identify any counterfeiting).
 
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