Quality
Quality Management System
The QualityManagement System (QMS) focusonto meet customers’ needs and requirements. Ourworkprocedures and documentation follows current guidelines cGMPfor medicinal products and ISO/IEC 17025standard -“General requirements for the competence of testing and calibration laboratories” for Medical Devices.
- Complies to cGMP and ISO/IEC 17025
- Complies to current international pharmacopoeia specifications, such asEur. Ph., USP, and JP
- Quality Risk Management system based on ICH Q9 and Q10.
- All methods and equipment are validated
- Regularly audited by customersand authorities.
GMP Certificate & ISO 17025 accreditation
Certificate of GMP compliance issued by Medical Product Agency (MPA) in Sweden. Accreditation for analytical laboratories issued by SWEDAC.
All methods and equipment used are validated according to Standard Operating Procedures including the outcome of annual periodic reviews.
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If you need support or scientific advice, don’t hesitate to contact us!
