Some reduced tests analyzed periodically have been recorded in the specification of the drug substance issued from the manufacturer of the drug product. Based on the submitted document, is it acceptable that the certificate of analysis of the batch of the drug substance used for the manufacturing of representative product batch includes the reduced tests without full tests?

刊登日期:2019-11-22  |  點閱次數 : 1596 次 

Yes. Please provide the following documents according to Article 9 of Regulations for Registration of Medicinal Products: "Raw materials should be tested against each specification item. Documented operational procedures of items exempted from tests should be submitted, along with the certificates of analysis of the batch subject to full tests."



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