Quality is important to Bioglan
All manufacturing activities are regulated by the quality system and controlled by the Quality Assurance department. The quality system fulfils the EU and FDA GMP (Good Manufacturing Practices) requirements as well as the ISO 13485 standard for Medical Devices.
Our manufacturing authorisation 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. We can even be your QP release site for other types of products.
- The facilities are regularly inspected for GMP compliance by MPA (last inspection was made in February 2012). <media>GMP certificate</media>
- The facilities are regularly inspected for ISO 13485 compliance by Intertek Semko Certification AB (last inspection was made in August 2012). <media>ISO certificate</media>
- The facilities are regularly inspected for GMP compliance by international customers
- The facility is registered as manufacturer at United States Food and Drug Administration, FDA
- Bioglan has an in house QP
The quality policy at Bioglan is based upon
- Long term relationships and confidence with customers
- Continuous training of personnel
- Follow-ups of established work to gain knowledge in order to develop further
- Close following of new and changed regulations and scientific progress