| 新的GMP形势下生产粉针制剂用纯化水制备系统及管路系统改造 |
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| 引用本文： | 许永红,张彦慧,王强,侯亚林,柏艳柳,姚伟伟.新的GMP形势下生产粉针制剂用纯化水制备系统及管路系统改造[J].医药工程设计,2009,30(5):8-10. |
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| 作者姓名： | 许永红 张彦慧 王强 侯亚林 柏艳柳 姚伟伟 |
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| 作者单位： | 1. 华北制药股份公司天翔分公司,河北石家庄,050035
2. 河北以岭医药研究院,河北石家庄,050035 |
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| 摘 要： | 用于药品生产的纯化水的质量直接影响到药物产品的质量和整个水系统中注射用水的质量,所以纯化水的制备是药品生产过程中很关键的一环。在与欧盟GMP相接轨的新版中国药品生产GMP实施之前,根据欧盟GMP的相关要求,在本次改造过程中对纯化水制备系统和管路系统进行分析和改进,从而保证粉针制剂生产用水系统能够达到新版中国药品生产GMP的要求。
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| 关 键 词： | 纯化水 反渗透技术 纯化水制备系统 管路系统 粉针制剂 |
Reform of Purified Water Preparation System and Its Pipeline System for Powder Formulation Production under New GMP Requirements |
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| Affiliation: | Xu Yonghong, Zhang Yanhui, Wang Qiang, Hou Yalin, Bo Yanliu, Yao Weiwei (1. Tianxiang Company ofNCPC Shijiazhuang, 050035; 2. Hebei Yiling Academy of Medicine Shijiazhuang, 050035) |
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| Abstract: | The quality of purified water used in pharmaceutical production will directly affect the quality of the produced drug and the quality of injection used water. Thus, the preparation of purified water is the key step in drug production. Before the execution of new version of Chinese pharmaceutical production GMP, which is conform to EU GMP, the purified water preparation system and pipeline system were analyzed and improved, based on the requirements in EU GMP, in the reform process, so that, the powder formulation production used water system can be guaranteed to reach the requirement of new Chinese pharmaceutical production GME |
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| Keywords: | purified water reverse omosis technique purified water preparation system pipeline system powder formulation |
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