Working at a High Standard to Meet Your Expectations
As a pharmaceutical company, Nordmark Pharma is aware of its great responsibility to provide products which fulfill the highest level of quality and regulatory requirements. Quality Assurance is an essential part of the manufacturing process and assures the quality of all batches produced at every stage along the way. This assurance is achieved by performing the monitoring functions as laid out in the QA system.
At Nordmark Pharma, we run facilities certified as Good Manufacturing Practice (GMP) compliant. 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 many more.
Through Our Excellently Trained Employees
Our Quality Assurance system is based on written standard operating procedures (SOPs) that describe all our relevant processes. 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 and ourselves. We ensure the efficiency and accuracy of the system with qualified employees and thorough ongoing training. More than 60 staff in several laboratory units and work groups focus their expertise to service Nordmark’s production operations – continuously building an expertise from which our customers and cooperation partners benefit.
Our State-Of-The-Art Analytics
Our analytical techniques allow us to gain detailed insights into the composition and characteristics of our collagenase preparations. Routine analytical tests are carried out to monitor enzymatic activities of collagenases and other proteolytic enzymes in analytical laboratories for natural substances. Bioassays described in the literature as well as SDS-PAGE analysis methods have been established and validated in accordance with international ICH (International Conference on Harmonization) guidelines. High-performance liquid chromatography (HPLC) technology combined with mass spectroscopic methods enable us to assign the activities to the appropriate molecular masses. Especially adapted protocols allow a clear characterization of individual enzymes
Storage stability testing is carried out in climatic chambers in accordance with international ICH guidelines. Long-term storage stability is tested by monitoring enzyme activities, enzyme degradation by SDS-PAGE or HPLC, as well as microbiological contamination. Short-term accelerated stress conditions, including elevated temperatures and humidity, are evaluated to assure product stability under conditions which might occur during transportation.
In summary, from the enzymes used for research and process development to those employed for clinical trials and commercialization, our robust manufacturing process is tightly controlled and focused on producing quality product.
- Stringent quality control
- Reliable lot-to-lot consistency
- Accurate analysis of proteolytic enzyme activities
- In-process controls
- Low contamination levels
- Production according to GMP guidelines