>> The process simulation test should imitate as closely as possible the routine aseptic manufacturing process and include all the critical manufacturing steps...>> Annex 1 : Manufacture of Sterile Pr

界定Tc，Tg’确定初次干燥步骤中的最大允许产品温度对冷冻干燥过程至关重要，因为高于该温度会导致冻干饼结构损失。以一个无定形配方为例，对于

Why is Steam Quality Testing considered so important by SRA inspectors? What should a company wishing to be compliant with WHO/PICs/EU/MHRA cGMP be doing and why?Ian Thrussell – GMP Consultant, Park

The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public he

2021 年 6 月 1 日上午 8:30-10:30（北京时间），识林将再次携手 IPEM 教育项目和美国霍金路伟（Hogan Lovells）律所举行线上讲座，介绍 FDA 细胞治疗产品的法

临床研究阶段的药物警戒要求和上市后一样吗？

生产线之前的产品10批一清洁，已经做过验证及清洁效期的确认，现拟增加为11批一清洁（清洁方式、存放方式等都不变，只是批数增加）。问：是否还

现在化药注射剂仿制药注册申报的资料是按哪份文件要求整理的

细胞培养的SOP上如此描述“……培养至18～22天，取出原液XX千克……”这里的下限18天是应该理解成培养至432小时（既完完整整的18天），还是时间跨度

我们需要把采血袋从普通传递窗表面擦拭消毒传递到B级区，需要做哪方面的验证，怎么做合适，传递窗有风淋和紫外

Garth Boehm, Lixin Yao, Liang Han, Qiang ZhengAbstract The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the p

On April 14, the U.S. Food and Drug Administration (FDA) released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities Durin

The U.S. Food and Drug Administration (FDA) on March 31 announced the establishment of a special emergency program to help speed actions on possible COVID-19 therapies. The Coronavirus Treatment Accel

On October 10, thirteen years after China’s Measures for the Administration of Drug Recalls first took effect, China’s National Medical Products Administration (NMPA, formerly “China Food and Dr

The COVID-19 pandemic has resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities on hold due t

On June 4, 2020, the U.S. Food and Drug Administration (FDA) updated the Compliance Program Guidance Manual (CPGM) to include a program for “Inspections of CDER-led or CDRH-led Combination Products.

固体制剂车间D级洁净区，干燥器补集袋、烘箱盘子布、工作服洗涤后是否需要有消毒一步？如何消毒。洗衣机是否需要定期消毒？如何进行

On September 11, the U.S. Food and Drug Administration (FDA) issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,”

Earlier today, FDA published its finalized Data Integrity Guidance.  The Final Guidance is entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” and updates the agency