CPhelan
Starting to get Involved
Hello,
We are heading into a first in human clinical trial this year and I am getting all of the kitting and labeling documentation together.
I have the label created and uploaded the template onto our electronic QMS, though it is not yet released and still in a collaboration phase.
There is still some information I'm missing form some of the kitting labels however is it best practice to upload and approve a template to be used for the device and packaging labels. Then when making the actual label for a specific lot with a specific expiration date would you download the template create your label, save a copy of the label and go through a labeling check list to verify all of the necessary information is on the label?
I just don't think I should have all of the final information on the label thats uploaded to the QMS but maybe the label should be approved and released but I can't see how this would be practical.
I just wanted to ask what was best practice with other companies.
Any advice is greatly appreciated.
We are heading into a first in human clinical trial this year and I am getting all of the kitting and labeling documentation together.
I have the label created and uploaded the template onto our electronic QMS, though it is not yet released and still in a collaboration phase.
There is still some information I'm missing form some of the kitting labels however is it best practice to upload and approve a template to be used for the device and packaging labels. Then when making the actual label for a specific lot with a specific expiration date would you download the template create your label, save a copy of the label and go through a labeling check list to verify all of the necessary information is on the label?
I just don't think I should have all of the final information on the label thats uploaded to the QMS but maybe the label should be approved and released but I can't see how this would be practical.
I just wanted to ask what was best practice with other companies.
Any advice is greatly appreciated.