A Starch, pregelatinized CEP of the European Pharmacopoeia monograph is often referred to as a Starch, pregelatinized Certificate of Suitability (COS). The purpose of a Starch, pregelatinized CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Starch, pregelatinized EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Starch, pregelatinized to their clients by showing that a Starch, pregelatinized CEP has been issued for it. The manufacturer submits a Starch, pregelatinized CEP (COS) as part of the market authorization procedure, and it takes on the role of a Starch, pregelatinized CEP holder for the record. Additionally, the data presented in the Starch, pregelatinized CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Starch, pregelatinized DMF.
A Starch, pregelatinized CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Starch, pregelatinized 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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