| 谈大容量注射剂配料系统质量风险及控制方法 |
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| 引用本文： | 陈月菊.谈大容量注射剂配料系统质量风险及控制方法[J].企业科技与发展,2011(8):46-47,51. |
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| 作者姓名： | 陈月菊 |
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| 作者单位： | 广西南宁百会药业集团有限公司,广西南宁530003 |
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| 摘 要： | 文章探讨大容量注射剂配料系统潜在质量风险因素及其控制方法。大容量注射剂配料系统质量风险因素主要存在于6个方面：即工艺用水、原辅物料、生产环境、过滤系统、生产设备、人员方面。对这6个方面进行分析探讨,找出在今后生产中降低配料系统潜在质量风险的方法。
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| 关 键 词： | 大容量注射剂 配料系统 风险因素 控制方法 |
On Quality Risk of Large Volume Injection Batching System and Control Methods |
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| Authors: | CHEN Yue-ju |
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| Institution: | CHEN Yue-ju (Guangxi Nanning Baihui Pharmaceutical Group Co.,Ltd.,Nanning Guangxi 530003) |
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| Abstract: | The paper discusses the quality risk of large volume injection batching system and relevant control methods. The main six quality risks include processes water,raw materials,production environment,filtering system,production equipment and the staff.Based on the elaboration of six factors,the paper puts forward solutions to the quality risks for future production. |
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| Keywords: | large volume injection batching system risk factor control method |
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