Documents & Quality
Quality is the core of our Pharmacosmos DNA, and we offer
an array of documentation to certify our quality and facilitate
the approval process of your innovations using our dextrans.
Unparalled Pharmacosmos quality
Controlled and covered by a very efficient Quality Management System, Pharmacosmos manufactures dextran fractions of high quality and unique product purity to customers worldwide. Our facility and systems are regularly inspected by national and international health authorities including the Danish Medicines Agency (Lægemiddelstyrelsen) and the United States Food & Drug Administration (US FDA).
Pharmacosmos continuously strives to fulfil our customers’ expectations and demands when it comes to the quality, safety, and efficacy of the products we manufacture. We regularly update and improve our production, documentation, control and quality across all relevant processes, and we employ and train passionate professionals who are keen to strengthen their knowledge of best practice operations.
In all departments, the validation and qualification of processes, equipment and methods of analysis are of critical importance for our ability to provide products at a constant quality, purity, safety, and efficacy with minimum batch variation.
Documentation on Pharmacosmos Dextran comes in 3 categories:
· Freely available:
This includes the (non-authorized) EDQM documents for Pharmacopeia Dextran 1, 40, 60 and 70, the Material Safety Data Sheet and Pharmacosmos’ GMP certificate, which can be found on this homepage under the relevant products.
· Available to customers:
All dextrans delivered from Pharmacosmos are delivered with a BRC (Batch Release Certificate) equivalent to COA (Certificate of Analysis). Additional statements on non-animal origin, Latex, GMO-free etc. are available to Pharmacosmos’ customers upon request.
· Available under combined Sales and Supply Agreement (SSA) and Quality Service Agreement (QSA):
Please read more about it here.
A uniquely qualified supplier
Pharmacosmos is the only dextran manufacturer that has been granted certificates of suitability to the monographs of the European Pharmacopoeia (EP) from the European Directorate for the Quality of Medicines (EDQM) for specific pharmaceutical quality dextran fractions, and Pharmacosmos is the only dextran manufacturer holding certificates from the US FDA and European Directorate for the Quality of Medicines (EDQM).
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