Quality assurance for you: the EU’s GMP standards
As a pharmaceutical manufacturer, ZytoService is bound by the European Commission’s strict GMP (”Good Manufacturing Practice”) standards for pharmaceutical production. The term GMP refers to a set of guidelines that serves to assure the quality of production processes and environments when manufacturing drugs and active substances. The GMP guidelines define specific criteria according to which pharmaceutical manufacturers are obliged to control all relevant processes from arrivals and production to distribution and quality assurance.
The implementation of these standards engenders a quality management (QM) system of compulsory criteria for all relevant processes in the areas of production, quality control and quality assurance – and we abide by these! Our QM system consequently ensures that only products of consistently high quality are produced and distributed for you.
The core elements of our QM system are:
- To assure the uninterrupted traceability of all the raw materials used
- To use only drugs licensed in Germany and to audit all suppliers for compliance with statutory regulations
- To prepare products in cleanrooms that comply with the criteria for the highest cleanroom class A in B
- To constantly monitor the maintenance of sterile production conditions
- The product-specific definition and validation of all relevant production processes in clear, binding standard operating procedures (SOP)
- Division of responsibilities into production, quality control and quality assurance
Independent officers within the company perform separate checks in order to implement the GMP specifications. The company's responsible officers are the head of production, the head of quality control, the representative for pharmacovigilance, the commissary for information and the qualified person. The qualified person is also personally responsible for the legal conformity of all the company’s production-related processes – and is not subordinate to the management in pharmaceutical questions.
Compliance with GMP standards is also monitored and regularly controlled by the competent supervisory authorities – as is the case with all European drug manufacturers. This means maximum safety for you!