Such CEPs are very important for customers to register products where the ingredients are seen by the authorities as active pharmaceuticals. To achieve a CEP, it’s a prerequisite that the product is in compliance with the specifications and tests defined by the European Pharmacopoeia, the manufacturing site operates under full GMP and that all Q7 Pharma standards are implemented.
CEP’s are not only relevant for EP member states because more and more countries outside of Europe (eg Canada acknowledge the CEPs as part of an easier registration process).
With the submission of CEP documentation for Beta-Carotene to EDQM, DSM has responded to specific customer requests to use Beta-Carotene as active pharmaceutical ingredient in existing or future products with a formal Pharma registration status.
Source: DSM
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