Black pen in CGMP

Dear All

I m having a question ,weather black pen is allowed in cGMP docouments for signature purpose.


I don’t see how this should be a problem.

The norm is black or blue unless your corporate standard has a different outlook.


gokeeffe is right. The old school of thought was that if you use blue ink, you could tell originals from copies. Not so true anymore with color copiers. So unless you have a policy / procedure that requires blue, black is ok.

Dear, Himanshu
The color of black or blue as per Company standard, there are no Black Color requirment for cGMP. but the pen will be bold not Ink pen .

I agree with all of the above - there is no specific requirement for blue or black ink in GMP, BUT remember some companies have a COMPANY REQUIREMENT for a specific colour. No funny colours like violet or green!

One of the reasons that blue ink has traditionally been frowned upon, was that a good few years ago photocopiers were not good at copying blue text. My father used to use a “special” light blue coloured pencil specifically for annotating drawings as the pencilled notes would not copy. Another reason is that blue fountain pen ink would fade over a relatively short time. It is also not terribly waterproof.

One company, I worked for as a consultant, insisited that we used, what we jokingly called “validation pens”, a particular make of rollerball with indellable ink.

True true and true. However, pending what industry, ISO 13485 for medical device provides specific guidance for documentation practices. Throughout the FDA regulated industries, known practices is to use black or blue ball point pens. Ball point print remains more legible when wet and does not not smear as easily like roller or gel pens. However, to differentiate between the original copy and a photocopy, you must stamp the non-original copy as a duplicate or copied copy.

I’m very hesitant to ask this, but it’s causing me heartburn with a colleague, and this seems like the appropriate forum. When it comes to the use of various ink pens, does anyone have any experience indicating any kind of negative regulatory repercussions from the use of gel pens? It is my position that the specific type of ink is not even remotely important in the grand scheme of things, provided the writing is clear and legible. Is there any regulatory precedent that says otherwise? It’s my opinion that the use of more water-soluble inks is really a business risk, and not a regulatory one (the risk being that water on the record will smudge the recorded data). Does anyone have any experience with water damage that selectively destroyed gel pen records, leaving ball point and/or printed records unscathed? Allow me to mention that I fully appreciate any time and effort that goes into answering question(s) as mundane as these, and that I intend for my future contributions to this site to address topics of far greater relative importance.