As a pharmaceutical manufacturer for pharmaceuticals, ZytoService is bound by the EU-GMP standards ("Good Manufacturing Practice"). They include guidelines to ensure quality assurance and quality management during pharmaceutical production. This means that the processes and environmental conditions during drug and active ingredient production are standardised and follow clearly defined standards. All processes related to production, including incoming goods, production, final inspection and distribution, are clearly controlled and strictly monitored.
The implementation of these standards creates a quality management system (QM system) that is monitored internally by an independent quality assurance department. This ensures that we only produce and market products of consistently high quality.
In order to implement the strict European Commission GMP guidelines for manufacturing medicinal products in the optimal manner, independent persons in positions of responsibility audit each other. These include production management, quality control management and the Qualified Person. Compliance with these standards is also monitored and regularly checked by the responsible supervisory authority.
Quality management system
Continuous high quality
Seamless traceability
Monitoring and control
Separate responsibilities
These are the key points of the QM system at ZytoService: