cGMP COMPLIANT INDELIBLE INK PENS, AND METHODS OF USING THE SAME

摘要

The present invention conveniently and practically addresses a significant need. The invention provides pens that are clearly labeled with a phrase to indicate that the pens contain GMP-compliant indelible ink. In one aspect, the invention provides an apparatus for writing, comprising: (i) indelible ink; (ii) a construction suitable for containing the indelible ink; and (iii) a text-based label on an outer surface of the construction, wherein the label comprises a word or phrase intended to validate the apparatus for GMP compliance, FDA compliance, and/or EMEA compliance. In another aspect, a method is disclosed for providing a writing procedure that is GMP-compliant, FDA-compliant, and/or EMEA-compliant. In yet another aspect, the invention describes a method for labeling a pen containing indelible ink.

主权项

1. A method for testing and labeling a pen containing indelible ink for documentation and audit purposes, said method comprising:
(i) constructing a pen containing indelible ink; (ii) testing said pen for quality and compliance with GMP, FDA, or EMEA regulations; (iii) generating a certificate of compliance to document acceptance of said pen, wherein said certificate of compliance includes an identification number; (iv) selecting a phrase that indicates said pen is GMP-compliant, FDA-compliant, or EMEA-compliant; and (v) attaching a label comprising said selected phrase from step (iv) onto said pen from step (i), wherein said label further comprises said identification number from step (iii).