We are looking for a ball-point pen and pencil that can be used in at least grade D.
The auditor pointed out the risk of particle
Do you know about the pharmaceutical pen non particle happen?
please comment ,
First of all, please don’t have pencils around. It can be erased, and that is a Good Documentation Practice violation. Everything should be written in pen.
Also, I’m surprised about the discussion of pens and particle generation. Paper generates way more particles than a pen ever could. Equipment generates more than paper ever could, and people generate (by far) the most. So from a risked based approach pens are a infinitesimally small potential source of contamination - unless you are using a pen I’m not aware of.
I think the response to the auditor, might be:
"We have a particle mitigation strategy which includes HEPA filtered air, gowning practices and procedures and hand wash practices, and followed up by a regimen of particle monitoring, and refer the auditor to your various procedures/SOPs.
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Thank you for your kind response.