Quality System

All of Katwijk Chemie’s products are manufactured under a qualified Quality Management System (QMS) in our plant in Katwijk in the Netherlands. Our QMS meets the current Good Manufacturing Practices (cGMP) requirements of ICH Q7 and other applicable guidelines for API manufacturing. This includes the manufacturing of products using validated processes. These processes are being monitored and continuously validated and improved, also by rigorous annual product quality reviews. Our plant in Katwijk is regularly inspected by the US (since 1976) and European health authorities (since 2003). Our pharmaceutical customers also carry out some 20 GMP audits each year. GMP auditors are received with confidence and in openness with the final goal to further improve the quality of our products and system.

Our Active Pharmaceutical Ingredients (APIs) meet the specifications of the current Pharmacopeias (USP, EU and JP) and they are compliant with ICH Q7 guidelines. For all our APIs the risks for mutagenic impurities, such as nitrosamines, have been evaluated.

Quality control - then & now

Quality Control – then & now

Quality Culture

Our Quality Management System (QMS) drives continuous improvement in quality throughout our company. Our employees are trained to use the QMS to meet the requirements set for our products.

We believe that quality culture, HSE culture and operational excellence are mutually reinforcing. Our QMS takes this broader perspective into account and implements practical benefits into the daily work of our employees. The benefits of the QMS beyond the requirements for patient safety are widely appreciated among our people.

We appreciate the need for procedures and for documenting any action or decision that is critical for quality. However, we feel that quality culture is even more about our people being capable, motivated and empowered. We believe that quality improvements should flow both top-down and bottom-up. With an average tenure of >15 years our workforce has more than 1500 years of cumulative working experience in our company. The experience and commitment of our people are the foundation for Katwijk Chemie’s strong quality culture.

Regulatory Affairs

Drug Master Files (DMFs) for our products have been registered in many countries worldwide, including the United States, Europe and Japan. Most US DMFs are Available for Reference. European Certificates of Suitability (CEPs) have been issued for our major Active Pharmaceutical Ingredients (APIs) marketed in Europe.

We offer our customers quick and accurate service related to Regulatory Affairs. Because our organization is small and agile, we can generally consult on cross-functional questions at short notice. We have a long-standing reputation for answering regulatory questions from health authorities and pharma customers satisfactorily and on-time.