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PS《流程工业》 | 14 Apr 03:18 2015
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PS《流程工业》制药E-newsletter 2015年4月期

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2015年4月

 
本月重点推荐
【独家】专业团队致力于高品质注射用药
自2006年12月投建和运营以来,赛进制药始终高度关注药品安全性--率先引入美国食品和药品管理局(U.S.FDA)提倡的质量源于设计理念,严格按照美国FDA cGMP标准兴建与运营,第一个在亚洲采用全封闭隔离联动技术,整合全球最先进制药工艺...[详细]
【策略】《生物类似药指导原则》下的候选药物开发策略
  本月3日,CFDA发布了《生物类似药研发与评价技术指导原则(试行)》(以下简称《指导原则》),该文首次对明确了我国药品监管部门对生物类似药(biosimilar)定义,注册分类,以及其药学、非临床,临床研究与评价中应遵循的基本原则...[详细]
【监管】药品电子监管码飘在「云」上,公平竞争从何谈起?
2015年春节前,一个营销人员拜访广东众生药业股份有限公司总经理陈永红,希望利用数据为这家上市药企设计一个市场解决方案。「这是我们公司的数据啊?」看到方案,陈永红觉得不可思议,因为方案所用的数据,包括各类药品的批次、流向和数量都来自众生,但陈永红却从未看过...[详细]
 

主题:质量管理

把风险降低到最小程度
  提高无菌生产线的可用性也就意味着提高了因产品输送管道和原材料供应管道安装错误而带来的风险。局部的无菌设计错误和卫生清洁不足,在日常生产过程中几乎看不到有什么影响和作用,但在较长的生产周期中却可以因局部污染导致灾难性的后果。典型的原因..[详细]
制药企业应用一次性技术风险控制分析
一次性技术与一次性理念近些年在国内制药领域被接受的程度不断提高,然而其发展进程相对于欧美发达国家仍然存在一定差距--本文以一次性生物工艺袋为例,从制药企业角度概括地分析使用一次性产品应如何进行风险控制,主要内容涉及一次性技术筛选,有效性及安...[详细]
最大限度防控微生物污染
在实际工作中,由于洁净服洗涤设备本身是可能对洁净区造成巨大的污染威胁,洁净服的清洗效果方法及程序必须有效可靠,不能留下任何残余物(包括颗粒物、纤维、微生物、洗涤剂和水渍等)。洗涤设备在洁净区必须高度密封,每次使用的洁净服得到彻底清洁....[详细]
更好地提升片剂生产质量
本文结合目前片剂生产中存在的问题,对普通压片机和高速压片机工业化生产及技术等方面进行了较详细的对比研究。通过普通压片机和高速压片机 各项技术指标对比,探讨了二者对片剂大批量生产的影响。高速旋转压片机各项技术指标均优于普通压片机,但...[详细]

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有利网 | 30 Mar 14:42 2015

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Kennedy F Sanchez | 29 Mar 19:29 2015

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有利网 | 28 Mar 13:12 2015

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