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.

Good Manufacturing Practice

Quality assurance

Quality control

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.

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Quality management system

Continuous high quality

Seamless traceability

Monitoring and control

Separate responsibilities

These are the key points of the QM system at ZytoService:

  • Ensuring complete traceability of all raw materials used in Germany
  • Exclusive use of authorised medicinal products
  • Auditing suppliers for compliance with legal requirements
  • Production in clean rooms of the highest clean room class A in B
  • Monitoring compliance with aseptic production conditions
  • Product-specific definition of all production processes in clear and binding procedural instructions (SOPs)
  • Validation of critical processes (e.g. cleaning validation, transport validation, computer and software validation)
  • Qualification of all production-critical premises, plants and equipment
  • Separation of responsibilities (production, quality control, quality assurance) and expert (Qualified Person)