Quality
The Quality at Biosint is an history of achievements that arises in the past challenging the future.
We have a sound Quality Control System in place that is the strategic tool through which we achieve our business goals and prepare for the challenges of the future.
We are committed to maintaining the high quality of our products by continuously improving and updating of processes. To this end, all the activities supporting production processes are documented and reviewed in an organized and systematic manner in order to detect any possible opportunities for system improvement and development.
Our Quality Assurance and Control Systems comply with the principles of Good Manufacturing Practices issued by pharmaceutical authorities across the world.
Our in-house labs perform chemical and microbiological analyses and our specialist staff supervises, in addition to the end products, the raw materials and all in-between processing and production stages as well. Our control measures allow us to achieve real-time process monitoring, which is a guarantee of production quality.
All the analysis methods adopted are validated on the basis of accurate studies and lab tests.
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The manufacturing establishment has been subject to scheduled inspections by AIFA (the Italian drug authority) since 1982. FDA (Food and Drug Administration) inspected and registered Biosint in 2004. Biosint successfully passed the paper inspection by PMDA (Pharmaceuticals and Medical Devices Agency of Japan) in 2012. |
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