The client aimed to achieve the best GMP standard for spirits production in Europe. Their goal was to differentiate themselves from competitors based on quality assurance, ensuring that customers would choose their products even in the face of slight price differences.
Operating within the European market, our client must adhere to EU regulations while also preparing for inspections from international bodies such as the United States Food and Drug Administration (FDA). Their validation processes lacked comprehensive documentation.
The implementation and maintenance of the GMP system is a highly challenging, time-consuming, often tedious, and demanding task. It is so burdensome that most individuals working within this system would respond negatively to the question of whether to implement even elements of GMP if it is not directly required by law. The topic is very …
Implementation of GMP requirements in industries outside the pharmaceutical sector Read More »
We provide comprehensive and goal-oriented quality services for companies in regulated industries and beyond. We handle everything from step one and deliver more than you expect. On time.
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02-222 Warszawa
Wrocław office:
ul. Piłsudskiego 13
50-048 Wrocław
ecvalidation is a team of experts specializing in validation and qualification services of software, equipment, installations, rooms and processes.