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

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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

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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

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The pharmaceutical supply chain is extremely complex and relies on manufacturing sites located throughout the world. The COVID-19 pandemic has placed significant strain on this complex system.  It ha

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今年四月份公司生产的三批工艺验证批胶囊其中一批成品溶出度结果偏低（该批溶出度结果单值未超下限但普遍偏低，且均值相比同工艺验证另外两批

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葡萄糖注射液考察过程中5羟甲基糠醛升高的原理

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在细胞培养过程中，如何追溯整个生命周期？不同的细胞是由同一个细胞分化而来，如何溯源并做到区分？