Frequently Asked Questions

According to the ICH Q7, which are the GMP guidelines established by the FDA, it is required that all handwritten entries to be recorded in indelible ink to avoid deviations caused by water or steam. However, it is hard to tell if a pen has indelible ink just by looking at it. Using a tested, clearly-labeled, and certified GMPPEN eliminates any uncertainties thus preventing deviations.

We do not carry those regularly, but special order could be arranged if a purchase is made in large quantity (>1000).

Recent trends show that companies are switching from black or blue ink to blue ink only, so that one can easily tell the original document from the copy.

We have an established SOP for the process. Download our SOP if needed, for your documentation purposes.

Of course. Send your artwork or a message to us and we will custom-make the GMPPENS for you if a purchase is made in a large enough quantity (>1000).

Yes, due to its custom nature, custom labels require a minimum of a 1000 pen purchase.

Certainly. Simply provide us with your account details and we will remove your shipping and handling charges.

Yes, we offer 10% discount for orders of 500-999 GMPPENS. 20% discount for orders of 1000 or more GMPPENS.

Sure. Call (919-246-4896 -- M-F, 9-5 ET), fax (610-471-5101), or email (sales@gmppens.com) your request to us and we will be happy to send you some free samples.