Tag Archives: Laboratory Manager

Quality vs. Sales in a GMP Environment

“Good Manufacturing Practice (GMP) is the part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation (MA) or product specification. GMP is concerned with both production and quality control.” (MHRA)

GMP

What really matters?
As a laboratory manager for several years, in various contract laboratories carrying out analysis of food, water and pharmaceuticals, my number one concern has always been Quality. Whether relating to government regulatory authority compliance or independent accreditation bodies, the standards required not only ensure public/patient safety but also provide consistency and a high level of understanding and integrity amongst the scientists carrying out the work, provided they’re trained correctly.

In a laboratory where the business depends on making a profit however, it can be quite a battle with senior management on a regular basis to explain why, for the scientists at least,  Quality will always take precedence over Sales.

This is not the kind of thing you can explain in a half hour chat over coffee with your MD. You could barely scratch the surface in a 2 hour presentation to the board. That’s because working in a GMP environment is one of those things you can’t really explain to those who simply don’t ‘get it’ or are simply too far away in terms of their role in the business.  It’s a way of life, a culture that is almost innate and becomes apparent in everything you do. The number of times I’ve been signing and dating a document at the bank and written the date wrong. The overwhelming urge to cross through, initial and date before rewriting is quite a force to try and resist! Some of you reading will be nodding with a knowing smile…because you get it!

Whenever I write about Quality (always with a capital ‘Q’) I am not talking about it on the same level that your average sales rep might understand it. I’m sure, in plenty of businesses it’s considered quite a skill to be able to know when one can compromise quality for the sake of sales. Taking shortcuts to quickly improve profit margins or temporarily dropping standards for the benefit of a faster turnaround. Timing and risk….I get it, when talking business. When talking Quality however, this is the thing,  Quality cannot and must not be compromised ever. Without it we have no business.

Making It Work
So, how to find a balance? It requires commitment, dedication, integrity and passion. What also helps is doing your utmost to understand the business perspective in order to communicate and work with the people whose job it is to get  the numbers in, in an effective way. Learn their language so you can teach them yours.

 

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Pernicious Anaemia – part 2

…and the not so good part?

Well, about 6 weeks before my Pernicious Anaemia diagnosis, I started experiencing numbness and tingling, like pins and needles but not quite that, in my finger tips.  As it was only in my left hand initially I (stupidly!) put this down to excessive guitar playing.  That’s really quite terrible terminology because as any musician knows  there is, of course, No Such Thing as ‘excessive’ guitar playing! Pfft!

Anywho… despite finding it really strange I actually just ignored it for a couple of weeks.  Until it spread to my other hand.  Actually, I would have probably ignored this too if it hadn’t been for the horrendous neck and back ‘clicking’ that I’d been experiencing for a number of months as well as the interference with guitar practice.  Now, I don’t go rushing off to the doc’s for the slightest ache and pain (childbirth with no pain relief gives me a pretty high threshold for deciding whats painful and whats not!) but when there are multiple symptoms cropping up then I want to know what’s going on!

I went to my (excellent by the way – I’m very fortunate!) doctor and explained my concerns.  The excessive tiredness alone is what he seemed to be most concerned about.  He booked me in with the nurse to have my blood tested for, well just about everything.  I used to work in Immunology within the Pathology department of NHS hospitals and occasionally spent time in Haematology and Biochemistry too so I was satisfied that this was a thorough list of testing!  However he spotted my expression and asked if there was anything else concerning me.  So I said ‘well, yes. You haven’t mentioned the tingling in my hands’ (which was after all why I was there!).  However he didn’t seem concerned at all and said we’d look into that following my blood test results.  So, fine!  Who am I to argue?  I went away a lot less worried and just got on with work.

Work was turning into a nightmare by the way.  I work as a Laboratory Manager (immunological and genetic analysis – I won’t bore you) but it’s a very hands on role.  Y’know, pipetting and stuff.  My confidence started to ebb away very quickly over a period of about 6 weeks, probably from around the same time as the tingling started.  This was down to a combination of things but mostly:  forgetting simple names or jobs due out, making errors due to inability to concentration (I HATE making mistakes), and clumsiness.  I was desperately trying to hide all of these symptoms, putting it down to tiredness but secretly questioning what on earth was wrong with me? 

So a few days after my blood tests the results are in and, as you may have already seen (in Pernicious Anaemia – part 1… ahem!) I had low B12 and following further tests Autoimmune PA was diagnosed.  This did not explain the tingling however and I was once again sent home to see if it would just disappear.  It didn’t.  It got worse, much worse.

The tingling spread to my upper arms and back and by now was really concerning me, particularly as my back was affected and this was clearly something to do with my nerves.  You don’t spend 4 yrs on a Biomedical Science degree without learning a thing or three about the Central Nervous System!

So I went back to the doctor.  Actually I was sent there by my colleague JT in the middle of the work day as the strange sensation had me in tears and he was very worried.  I made an emergency appointment and went into the surgery (still crying!) telling my doctor something was just not right.  He checked me over with Babinski’s test - which I passed and then….get this….went on Wikipedia (I love Wiki!) to try and work out why I was having this strange symptom which to him could only have been one thing.  There it was in black and white, the Lhermitte’s sign that he thought I was describing was also associated with B12 deficiency!  News to both of us!

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