Our quality management system guarantees high performance standards
Quality is the fulfilment of requirements and expectations leading to sustainable customer satisfaction. This quality is the foundation of our relationship with our customers, who we supply with pharmaceutical drug products, active pharmaceutical ingredients, biochemicals and services. Quality is also key to our proprietary marketed products, such as Pankreatan®, Enzynorm® f and Thrombophob®.
We work according to international standards
All our facilities are current Good Manufacturing Practice (cGMP) certified. This certification is based on national requirements such as the German Medicines Act [Arzneimittelgesetz (AMG)] and the Ordinance on Manufacturing of Medicinal Products and Active Ingredients [Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV)]. Additionally, we adhere to the European Guidelines for Good Manufacturing Practices and other national and international regulatory frameworks such as the Pharmacopoeias, DIN EN ISO Standards and guidelines of the US Food and Drug Administration (FDA), CFR and so forth. Quality levels are agreed by the parties involved in the project and stipulated in a specification document. Frequently this specification is based on local approval for a drug product, i.e. the medicine must be produced in a manner that complies with the marketing authorisation. There is little room for changes, these are controlled by the Quality Assurance system and if applicable also monitored by the relevant regulatory authorities.
Our quality systems come to life through our excellently trained employees
Our Quality Assurance system is based on written standard operating procedures (SOPs) that describe all our relevant processes. All SOPs are compiled in a manual and cover different degrees of detail. They range from general, cross-facility guidelines to specific facility related work instructions. All instructions are regularly reviewed for relevance, adapted if necessary and communicated to our employees through training sessions. This ensures consistent quality and the further development of processes and methods to keep pace with the state of the art in matters of science and technology. The system, as well as the related manufacturing and control facilities, are regularly audited by the authorities, our customers or ourselves. We ensure the efficiency and accuracy of the system with qualified employees and thorough ongoing training.