A Roche, Biotine CEP of the European Pharmacopoeia monograph is often referred to as a Roche, Biotine Certificate of Suitability (COS). The purpose of a Roche, Biotine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Roche, Biotine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Roche, Biotine to their clients by showing that a Roche, Biotine CEP has been issued for it. The manufacturer submits a Roche, Biotine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Roche, Biotine CEP holder for the record. Additionally, the data presented in the Roche, Biotine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Roche, Biotine DMF.
A Roche, Biotine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Roche, Biotine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Roche, Biotine suppliers with CEP (COS) on PharmaCompass.