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 approved by the Swedish Medical Products Agency to import, release and wholesale 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 pharmacovigilance legislation (GVP). GMP is the regulatory regime all pharmaceuticals manufacturers must comply with to ensure that the finished pharmaceutical products possess the requisite identity, strength, quality, and purity and to ensure the safety of the patients. GDP is the regulation ensuring that all pharmaceutical products are distributed within regulated conditions. 


High Quality Production

All manufacturers with whom Bluefish cooperates are carefully inspected by Bluefish Quality Assurance (QA) department at regular intervals to ensure compliance with European requirements for pharmaceutical manufacturing. 

Pharmaceuticals that are imported into the EU are subject to quality controls (analysed) at an approved European laboratory to ensure that the pharmaceutical products fulfil the product specification. The laboratory is inspected and approved by the local competent authority and Bluefish QA department.  


Safety Monitoring

Bluefish Pharmacovigilance department is responsible for monitoring, identifying, analysing and reporting potential safety risks.

As a marketing authorisation 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 pharmaceutical 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 that leaves their plants for traces of pharmaceutical substances and Bluefish scrutinises the way in which manufacturers handle their waste. Bluefish's ambition is to constantly improve the work on environmental issues and Bluefish carefully monitors the areas on the agenda of public agencies.