Should all analytical methods listed in a drug substance specification be fully validated?

刊登日期:2020-07-23  |  點閱次數 : 898 次 

No. According to ICH Q2 and Handbook for Validation of Analytical Procedures, there are different validation requirements for identification tests, limit tests and quantitation tests. If analytical methods are based on the pharmacopeia that are approved by 《Regulations for Registration of Medicinal Products》, verifications of the compendial procedures are required to demonstrate suitability of the analytical procedures. Furthermore, according to the guideline 《Chinese Pharmacopeia─General Chapter 3070》, there is no need to verify basic compendial test procedures that are routinely performed. These basic compendial procedures include, but are not limited to, loss on drying, residue on ignition, various wet chemical procedures such as acid value, and simple instrumental determinations such as pH measurements.



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