All manufacturing activities are regulated by the Bioglan Quality System and controlled by the Quality Assurance department. The quality system fulfills the EU GMP (Good Manufacturing Practices) requirements as well as the ISO 13485 standard for MDD/MDR.
Our manufacturing authorization from the Swedish Medical Products Agency allows us to produce non-sterile semi-solid and liquid products, whether at pilot scale for clinical trials or at full-scale to supply a large commercial market.
The quality policy at Bioglan is based upon:
Quality is brought into the project from the start and QA support is present throughout the entire project process.
The Quality Management System at Bioglan covers:
We meet the quality control requirements that your product needs.
The Quality Control laboratory ensures compliance to specifications, from starting material to the finished product. The laboratory is equipped with equipment appropriate for topical products.
Stability study design and monitoring according to ICH (International Conference on Harmonization) guidelines are also performed.
The quality control system at Bioglan covers:
Bioglan utilizes a broad range of analytical techniques including:
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