GMP Pens PIC/S Guidelines on PENS usable in GMP environments - licenced from 123rf

Good Manufacturing Practice Pens or GMP Pens – Indelible Ink

Yes, we are still talking about the very old issue of Good Manufacturing Practice Pens or GMP pens and the most suitable colour of ink for pharmaceutical manufacturing pens and other issues. The various codes simply refer to “indelible ink”, as snipped from PIC/S Version 13 Good Manufacturing Practices, §4.7

Good Documentation Practices

4.7 Handwritten entries should be made in clear, legible, indelible way.

Black and blue – a bruising issue

Yes that’s right, black or blue or any other colour for that matter is not a GMP requirement, but we see so often that it becomes a site specific requirement. If specified in your PQS you are then obligated to follow it, as per the old quality saying, say what you are going to do, then do what you said you were going to do!

However, being playful about this, Annex 11 in the same PIC/S Good Manufacturing Practice code, Version 13, talks to the need for no decrease in control if an automated system replaces and manual (paper) system. So arguably, if you mandate blue “ink” then should the automated system, i.e. the screen, only have blue writing? It would be weird I agree.

Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.

Legally, well in most countries, if someone signs with an “X”, it is still binding to the author, regardless of the colour of ink. Of course, an X in our records would be almost impossible to attribute to the responsible employee, hence the first A of the ALCOA acronym.

I would like to continue to “play” with the Legible (permanent) or enduring nature of records. I have heard of companies banning gel ink pens. Yes, the ink is water soluble for about 5 seconds after writing but it does become “more” indelible soon afterwards and the ink does still show the original entry. Once dried, the record is harder to remove with a variety of common laboratory solvents, after all we paint our homes with water soluble paint.

Can we now validate our choice of Good Manufacturing Practice Pens and move away from the traditional ballpoint?

Going green?

But while we are talking about Good Manufacturing Practice Pens or GMP Pens, we seem to never talk about the “printed document”. Did you know that we can now remove all the information on it and re-use the paper?

New laser technology (“un-printers”) under development to do this very thing should raise alarm bells in the GMP world. While the cost saving on hardcopy archiving, recycling or secured paper disposal would be significant, the use of this technology would need to be highly controlled and documented.

  • What happens to batch record retention?
  • Where is the traceability on original information / documentation?
  • What are the documented controls against mis-use / falsification / fraudulent activity?

You can read more here – Unprinting Machines Could Use Lasers to Remove Ink from Paper.

2B or not 2B

While we all agree pencil is never acceptable in the GMP world, below are some common pros and cons to consider in your documentation world:

Data Integrity (DI)

So, while this blog may seem like a lighthearted delve into GDP, it is also highlighting (in bold above) the ‘ALCOA+’ principles of Data Integrity which is still a hot topic for inspection findings from all the major GMP agencies.

Inspectors from the TGA, FDA and MHRA, at the recent International Regulatory Convergence for MTP Good Manufacturing Practice in Melbourne, all reinforced that instances of DI issues are found in all organisations regardless of their GMP rating, location or economic environment. Regulatory perspectives can be read from the TGA presentation and FDA draft guidance.

Take a good look around

So now that we’ve raised some questions, take a look around your desk and ask how can the documents you’re working on be improved. DI and CI can be made using the most basic of equipment, even with the right, humble yet mighty, pen.

To find out more on Data Integrity, check out PharmOut’s public GMP training courses.

We also have an online course for Data Integrity in GMP environments.

Read more about GMP-related topics here and here.