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Quality Management System
We have developed and implemented Pharmaceutical Quality System concerning the production of medicinal products. Its aim is to ensure that the manufactured medicinal products are suitable for their intended use, meet the requirements of authorization for trade, have the quality and efficacy, and are safe for patients.
The Pharmaceutical Quality System includes Good Manufacturing Practice and Quality Risk Management to ensure the management of knowledge about the product and process according to ICH Q10 throughout the product’s life cycle.
The Quality Control Department is an integral part of Good Manufacturing Practice and includes the following laboratories:
- analytical chemical laboratory, including stability tests,
- microbiological laboratory,
- packaging materials control laboratory.
Pharmaceutical Quality System is continuously improved and adjusted to the current GMP Regulations in force in Poland and the European Union, in order to maintain the high quality of products. Its effectiveness is periodically monitored during Pharmaceutical Quality System management review, to define improvement actions.