非最终灭菌的无菌原料药无菌阶段生产设备流程研究

【摘要】 《药品生产管理规范(2010年)修订》自2011年3月1日正式实施,介绍了在新版GMP规范下,无菌原料药溶媒法生产工艺中,其溶配、过滤、结晶、分离、干燥、分装的不同生产设备流程。针对不同产品特性,可以选择不同的生产设备,保证药品质量。更多还原

【Abstract】 Manufacturing and Practice Guideline for Medicine(2010) revision> has been in force since March 1st,2011.this text present some contents of the process for manufacturing the aseptic pharmaceutical ingredient using menstruum under backdrop of new GMP edition,and also the different facility flow of preparation,filtration,crystallization,centrifugation,drying,and filling process.Choose different equipments considering characteristic of the product for quality assurance of the product.更多还原