摘要
目的 对如何建设符合“药品质量控制实验室良好操作规范”(GPCL)质量管理理念的细菌内毒素检测实验室的要素进行总结和分析。方法 从人、机、料、法、环5个方面,将药品质量控制实验室良好操作规范质量管理理念与细菌内毒素检测实验特点相结合,提出具体方法和参考经验。结果与结论 总结了药品质量控制实验室良好操作规范理念在细菌内毒素检测实验室中的应用。
Abstract
OBJECTIVE To summarize and analyze the factors of building the bacterial endotoxin test laboratory. These factors should meet the GPCL quality management concepts. METHODS Give Some specific methods and experience in five aspects were given, which combine the GPCL quality management concepts with the characteristics of bacterial endotoxin test. RESULTS AND CONCLUSION Summarizes The applications of GPCL concept for bacterial endotoxin test laboratory is summarized.
关键词
药品质量控制实验室良好操作规范 /
细菌内毒素检测实验室 /
质量管理 /
认证
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Key words
GPCL /
bacterial endotoxin test laboratory /
quality management /
certification
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蔡彤,裴宇盛,高华.
建设符合世界卫生组织“药品质量控制实验室良好操作规范”要求的细菌内毒素检验实验室要素分析[J]. 中国药学杂志, 2015, 50(14): 1251-1254 https://doi.org/10.11669/cpj.2015.14.017
CAI Tong, PEI Yu-sheng, GAO hua.
Analysis of the Factors of How to Build the Bacterial Endotoxin Test Laboratory with GPCL Quality Management Concepts[J]. Chinese Pharmaceutical Journal, 2015, 50(14): 1251-1254 https://doi.org/10.11669/cpj.2015.14.017
中图分类号：
R915
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参考文献
WHO. Good Practices for Pharmaceutical Quality Control Laboratories World Health Organization WHO Technical Report Series . No.957, 2010. Annex 1.
WHO. Good practices for Pharmaceutical Microbiology Laboratories Working Document .QAS/09.297/Rev.2 July 2010 Restricted.
PEI Y S,CAI T,GAO H,et al. Application of WHO GPCL quality management concept in laboratories for bacerial endotoxin detection . Chin Pharm Aff(中国药事),2013,27(7):693-699.
PA/PH/OMCL (08) 73 2R- OMCL Guideline on Qualification of Equipment- Core document. 2011:1-8.
EDQM OMCL PA/PH/OMCL (09) 64 2R- OMCL Guideline on Qualification of piston pipettes (Annex 6). 2010:1-20.
JPXVI (2011) . 2011:103.
USP36 (2013) Vol I . 2013:90-94.
EP7.0 (2011) Vol I . 2011:171-175.
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