FAQ
Drugs

If a copy of CEP provided by the manufacturer of the drug substance is submitted, can residual solvent testing be waived in the specification of the drug substance issued by the manufacturer of the drug product?

刊登日期:2019-11-22  |  點閱次數 : 1269 次 

CEP usually contains testing items and methods of the residual solvents for the analysis of the drug substance. According to PIC/S: Guide to Good Manufacturing Practice for Medicinal Products, the manufacturer of the drug product should consider whether the controls which are specific to manufacturing process of the drug substance should be listed in the specifications for establishing the principle of drug substance release or rejection.

 

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