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?
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:
|Good Manufacturing Practice Pens||Ink colour (blue vs black)||Blue and black inks are more legible on original and copied documentation than coloured inks. Blue is: easier to distinguish an original document from a copy, documentation accuracy / omissions at the time of completion are more visible when reviewing blue entries on black printed documentation, documentation reviews are quicker, “Right First Time” statistics increase. These Continuous Improvement (CI) initiatives can have long-term cost efficiencies in your organisation.|
|Good Manufacturing Practice Pens||Physical unit (single vs composite)||A pen without a lid is more favourable in production areas. If you lose the lid: What happened to the missing lid / pen? When was it lost or at which manufacturing step was it last used e.g. blending / compression / milling etc.? Is it in a batch? Has the supervisor been notified of the potential contamination issue? Has all the pen been recovered? (typical size, weight, internal components etc.)|
|Printers||Ink type (Laser, Inkjet, Ink melt, Drop-On-Demand)||Print quality, printing material (paper / packaging / plastics), cost of printer and replacement inks, efficiency and size.|
|Printers||Paper (plain vs thermal), packaging material||Print quality, printing material (paper / packaging / plastics), cost of printer and replacement inks, efficiency and size. Print quality on plain and thermal paper will deteriorate more quickly if covered with adhesive tape. Leave extra room. Thermal paper printouts are more susceptible to deterioration from heat sources e.g. photocopy scanners and laminators. Glossy vs matt finish packaging materials.|
|Stamps||Ink colour||Red ink is preferred to: stand out from the printed or recorded text, to highlight a process status stage and distinguish a copy from an original.|
Data Integrity (DI)
So while this blog may seem like a light hearted 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.