Quality Assurance

Quality Assurance

S Ahlén Medical Nordic AB (SAM Nordic) works in accordance to the European Commission’s Guidelines on Good Distribution Practice (GDP) of medicinal products for human use and is authorized by the Swedish Medical Products Agency to conduct wholesale activities with radiopharmaceuticals. SAM Nordic also holds a license granted by the Swedish Radiation Safety Authority to handle and trade with radioactive sources.

Our partners and suppliers hold GMP certificate and manufacturing license from the local Competent Authorities in each country. They are ISO certified and are working according to GDP. Quality related certificates are available upon request.

Briefly about the Quality Management System

The document control of the Quality Manual is carried out in the Quality Management System (QMS) in accordance to GDP. All internal processes and documentation used in the daily work of business are described in our Standard Operating Procedures (SOPs) and work instructions. These are available in an electronic format as part of the QMS. Internal audits are performed annually. It is crucial for us to know that we are up to standard and we continually strive to improve our quality management system.