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Quality from heart
24/04/2019
Site Introduction

We believe that space conditions are of primary importance for the quality of the Cephalosporin product. Our pharmaceutical facilities are closely supervised by the World Health Organisation (WHO), European Medicines Ageney (EMA) and U.S. Food and Drug Administration (FDA), which requires us to conform to cGMP (current Good Manufacturing Practices). These regulations, which have the force of law, tell us to take proactive steps to ensure that our products are safe, pure, and effective. Aware of the quality approach of the cGMP we wisely planned and executed our measurements starting with the selection of building materials and finishes, the water system, the flow of equipment, personnel and products, determination of key parameters like temperature, humidity, pressures, filtration, airflow parameters, cleanroom compliance.

It also governs the level of control of various parameters for quality assurance, regulating the acceptance criteria, validation of the facility, and documentation for operation and maintenance.

Both our cGMP consultant as well as our equipment are of European origin. We strongly believe in the strength and heritage of the European machinery industry.