Dextran Documentation

Documentation on Pharmacosmos Dextran comes in 3 Categories

1. Freely available:
   This includes the (non-authorized) EDQM documents for Pharmacopeia Dextran 1, 40, 60 and 70, the Material Safety Data Sheet and the GMP certificate of Pharmacosmos which can be found on this homepage under the relevant products.
2. Available to clients:
   All Dextran delivered from Pharmacosmos include the BRC (Batch Release Certificate) (also known as CoA (Certificate of Analysis)). Additional statements on non-animal origin, Latex, GMO-free etc. are available to Pharmacosmos client upon request. Furthermore authorized, specified Certificate of Suitability (CEP) can be requested against a fee from Pharmacosmos.
3. Available under Quality Service Agreement:
   Please see below.

Pharmacosmos Quality Service Agreement
Pharmacosmos’ core business focuses on delivering high-quality Dextrans for clinical use to the market. Our Dextrans are as standard provided with a Batch Release Certificate (BRC) describing analytical results and specification limits.

When services to support a client’s application of Pharmacosmos Dextran are needed, Pharmacosmos offers the Pharmacosmos Quality Service Agreement (QSA). The QSA is an annual subscription granting the client access to the following services and assistance from Pharmacosmos:

Quality Service Agreement:
• Certificate of Suitability (CEP) (for Dextran 1, 40, 60 and 70 EP)
• Letter of Access to US Drug Master File (DMF) (for USP / Pharmaceutical Quality Dextrans)
• Documentation of stability
• Letter of change notification
• Quality declarations / statements (BSE, ICH Q3D, etc.)
• Quality and Supplier Questionnaire
• Regulatory assistance (e.g. answers to regulatory authorities)
• On-site visit
• Quality System Review* (QSR) or right to access to 3^rd party audit report

* The Quality System Review (QSR) is a one-day on-site meeting enabling a client to obtain assurance that Pharmacosmos Quality System is adequate and that the manufacturing process is carried out according to GMP.

Please note all services are not available for all Dextrans.

During the last couple of years the demand from our clients to provide assistance beyond supplying high-quality clinical product has intensified. We try to meet our client’s needs via this standardized Quality Service Agreements