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