How many batches are required for process validation after the registration of domestic medicinal product is approved?

刊登日期:2019-11-13  |  點閱次數 : 2197 次 

After receiving approval of the drug registration, the manufacturer should conduct validation studies on three consecutive batches of products. Normally batches manufactured for process validation should be the same size as the intended commercial scale batches. If the results of process validation meet all specified criteria, the product can therefore be marketed. Please refer to “Regulations for Registration of Medicinal Products” Article 21 and “PIC/SGuide to Good Manufacturing Practice for Medicinal Products” Part I Annex 15.



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