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Batch Manufacturing Records
Call me old fashioned (I’m an old guy, mid-60s), but from my days as an undergraduate and early days as a scientist I was always mentored to use pencil for keeping records (data, observations, etc), and in our production facilities have maintained this practice. I find that pencil records are less likely to be spoiled by liquids etc.
During a recent GMP inspection, we were pulled up on this, and instructed that all production records (on our standard pre-printed sheets) should be recorded using a pen.
Any others have experience with this issue? Are records written in pen the norm?
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12 Replies
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yes, that is the expected standard for e.g. ISO 22716 - on the grounds that anything recorded in pen is much harder to alter after the fact
usage of Tipp-Ex and similar correctors is also frowned upon, for the same reason
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using pencils to record data in GMP documents (such as batch manufacturing records) are a no-no if you will look at Good Documentation Practices. one can easily alter the records if data is recorded using a pencil, compared to a pen.
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Yes, pen is a requirement in the US, black or blue colors. Permanent ink is preferred, but not required. Using permanent ink also gets rid of the durability/chemical resistance problem.
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Thanks for the responses…..interesting how times change.
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We were always required to use pen also. I started in the industry in 1992
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I’m an even older guy.
At school we used pens with dip in ink. This progressed to my student days and having fountain pens (I still have the Parker 51 pen that I used for my pre- and post graduate dissertations).
I used a fountain pen most of my career with the proviso of using “permanent” ink to satisfy the record keepers.
Ball point pens have never been favourite of mine. I find them too thin to hold comfortably for writing more than a few words/figures.
My early career introduced me to computers and even though at that time even the simplest calculating engine took up the space of a house, I could easily see where technology was taking things.
Anyway, cutting this rambling short, doesn’t anyone keep their records on computer?
A contract manufacturer I visited a few years ago told me (on enquiring about his computer setup) that they didn’t have a computer. They had a word processor for trial but their secretary was technophobic and wouldn’t/couldn’t use it. This was a manufacturer with contracts with some quite large retail outlets.
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@johnb pen and paper is by far the simplest, most robust and least corruptible way for manufacturers to record lot numbers, times of addition, etc. while they’re making batches on the plant
also, in the lab we keep records of our formulas and methods in notebooks as a rule, since it’s a 100% guaranteed way of preventing them from being wiped out when our network crashes, burns and suffers a total systems failure after being ‘upgraded’ by an ‘expert’ ‘consultant’
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Bill
All computer records should be protected against the disasters you describe by having at least two backups of the data - one of these stored away from the premises where the manufacture takes place.I agree there is nothing as good as a lab notebook for initial development work but I also strongly believe that as soon as the twinkle in your eye (or beaker) becomes a potentially useful entity then the details should be recorded on a modern secure system e.g a computer (with backup).
On the manufacturing side, hand written records are prone to damage from spillages, misinterpretation of poor handwriting, doodling and such.
Waterproof/chemical proof computer setups are available and with the increasing availability of computer compatible weighing and volumetric equipment + process control the case for exclusively hand written records falls away.
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We used a hybrid system that the FDA loved. The Formulas and Master Records were created in the Lab using a computer and an internal Excel Spreadsheet template. When the product was approved, the record would contain the Formula, Process instructions (a usable batch record), the COA and Testing Results. It was approved by the Technical Director and then uploaded to the server as a write protected document. A Hard Copy was printed, marked “Master” and kept at the front of a hanging file system.
When manufacturing was done, a copy of the Master Record was printed by the Production Manager and endorsed by the hierarchy. It was stamped copy. This copy was used to complete the manufacturing. For example it had a hard copy that was used by the pre-weigh room as well as the batch master. When manufacturing was completed, the copies were scanned into the computer, a Batch Record was saved in a sub folder, generally with the same name as the Master, but appended with the Batch number. The original hard copies were then kept right behind the hard copy in the vertical hanging files. In the end, we had an archived hard copy and a digital record.
We used Excel for many reasons. First, I was tasked to set-up the system and all the computers had Office Suite. I had already networked them together and installed a central server. I used a third party software product to complete an offsite back-up each night as well as a secondary back-up onsite. We lost a terminal here and there in the course of time but never the server and never a hard copy.
It did require a defined signature trail, good hard copy archiving as well as some IT procedures to ensure document integrity. One other advantage was that the Chemists under me were able to use OneNote for their lab notebooks. I spent many hours writing templates. On the first few regulatory visits, edits were suggested and after 2 years or so we had a very refined system. We could have evolved and used tablets to record the signatures, pre-weighs and manufacturing as long as we installed a secure signature add-on. (For example, pre-weigh person one weighs the raw material, goes to the signature field, enters a password and the signature field was populated. etc.) We didn’t do this simply because it was the very earliest days of tablets and the Production environment was harsh. It could be feasible today.
This system also meshes with computerized weighing systems and other process equipment. I use it in my lab and all my IKA mixers are “plugged in through the RS ports and fed into the Mixmaster software. All this goes into my lab notebook (OneNote).
I can agree that hard copies get messy. I have received back pre-weigh sheets that were translucent with oils. I had to get creative since they couldn’t get fed into a scanner. I would have to photograph them and upload the image into the digital batch records and then dry them on a window sill before I could file them with the hard copy.
The technology exists and it can support manufacturing in such a way the FDA is happy. Our system had passed an FDA Audit and in fact the inspector was very impressed. She recommended some changes (which we incorporated) to make it more compliant. It can be done. It is likely not feasible for all but the best funded facility willing to train their staff.
I still have the template (it is open source and really my IP) available as I share it freely. It does require some strong IT skill and knowledge to ensure that digital records are not over written and in order to understand how the spreadsheet is utilized. If anyone wants a copy (Excel format), email me and I will gladly share. This may sound harsh, but I will only share it with credible commercial manufacturers. It is far too involved for any environment short of that setting.
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Mark,
Thanks for your detailed information.
It’s a number of years
since I was involved in mainstream production processes but this was
most certainly the way things were going when I was doing factory audits
of contractors for own-label clients. Some, however, have fallen by the
wayside by not keeping up with technical developments (including the
one without the word processor). -
I will have to say that I tour a lot of plants and the Technical Staff I encounter are getting younger (or are we getting older?) and they are way more tech savvy. If you are a huge tech geek, there is a huge potential for integrating PLC’s, wireless technology and tablet based documentation.
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I do use excell to document formulas. Each file as an production order (expl: 203) and different modifications of the formulas as pages of excell file (example: 203A, 203B). When I have a formula that works the order number identify such definitive formula 203-2016. Each year the system is reseted. At the same time, those numbers are ink record manually on notebook; with the name of the product, and date in right pages, and observations in the left pages. Easy to manage and avoid mistakes.
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