Tag Archives: GMP

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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