Jenny about … Compliance – for whom and to what end?
Recall one specific GxP compliance inspection at a pharmaceutical manufacturer. The old ventilation system in the production area definitely failed to meet the requirements for the manufacturing of a newly introduced type of product. But the quality manager’s response was quite astounding: “What do you want us to change about the ventilation system?”
Their specific properties and particularities must be identified and described — especially weak points and difficulties. Once this has all been cleared up, creative and tailored – but also effective and efficient solutions – can be found and the infrastructure and processes established and maintained accordingly. This is the correct application of GxP as a scalable Q system.
But companies must really want and practice this culture. There isn’t simply an instant solution. I remember a young production manager who formulated his department goals when starting his new job: “I want us to organize and perform our work so that we only turn out products that fully satisfy GMP requirements. It doesn’t matter to us whether someone from outside the company checks in on
us our not.” With this understanding of quality assurance, he met his goal and managed to maximize efficiency and to reduce risks to a minimum for his company. That’s what compliance is all about!
■ Dr. Hans‐Beat Jenny
Dr. Hans‐Beat Jenny is an expert on GxP matters and has decades of industry experience. For a long time, the chemist with a doctorate degree had been involved in the research and quality assurance of a Basel pharmaceutical company, before taking over management of the Drug Inspection Agency of Northwestern Switzerland and later the Sector Licensing of Swissmedic. The former Deputy Director of Swissmedic has been working as a consultant since his retirement in 2016.