Quality & Safety

Maintaining the highest standards

At Bluefish, we accept nothing but the highest attainable quality and safety standards and demand the same high standards of our suppliers and distributors.

Our standards are maintained through strict policies and procedures. These procedures are carefully implemented and are applicable throughout the lifecycle of the product, from development to commercialization.

Bluefish is licensed by the Swedish Medical Products Agency to import, release and sell pharmaceuticals manufactured within the EU or imported into the EU.

The company is inspected regularly by the Swedish Medical Products Agency to ensure that Bluefish complies with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and pharmacovigilence legislation. GMP is the regulatory regime all pharmaceuticals manufacturers must comply with to ensure that the finished products possess the requisite identity, strength, quality, and purity and to ensure the safety of the patients. GDP is the regulation ensuring that all pharmaceuticals are distributed within regulated conditions and safety. 

High Quality Production

All manufacturers with whom Bluefish cooperates are carefully inspected by Bluefish quality assurance division at regular intervals to ensure compliance with European requirements for pharmaceuticals manufacturing. The company's manufacturers must be licensed by the European Medicines Agency and are inspected by that agency regularly.

Pharmaceuticals that are imported into the EU are subject to quality controls (analysed) at an approved European laboratory to ensure that the pharmaceutical fulfills the product specification. The laboratory is inspected and approved by the European Medicines Agency and Bluefish QP. The inspection is carried out to ensure that the laboratory is run in accordance with Good Laboratory Practice (GLP).

Finally, the company's QP releases the pharmaceutical product for sale. The release is conditional on all analysis results meeting specifications and on the pharmaceutical having been manufactured, packaged, tested and distributed in accordance with GMP/GDP requirements, as defined in accordance with EU directives and the approved marketing authorisation.

Safety Monitoring

Bluefish Pharmacovigilance team is responsible for monitoring, identifying, analyzing and reporting potential safety risks. The team actively reviews patient safety experiences, and uses an advanced database that allows for effective collection, assessment and prevention of adverse events.

We are continuously monitored by regulatory authorities. As a marketing licence holder within the EU, the company must meet the requirement of monitoring the safety of the products approved for use on the European market.

Pharmaceuticals and the Environment

Bluefish complies with all environmental legislation and requirements currently governing pharmaceuticals manufacturing. Consequently, the company verifies that manufacturers hold environmental permits and ensures that the results of analyses from test samples meet the requirements stipulated in environmental permits. In addition, Bluefish verifies that the manufacturers analyse the water which leaves their plants for traces of pharmaceutical substances and Bluefish scrutinises the way in which manufacturers handle their waste. Bluefish ambition is to constantly improve its work on environmental issues and Bluefish carefully monitors the areas on the agenda of public agencies.