摘要
目的:为提高我国无菌药品的质量控制水平提供参考。方法:通过对比传统的无菌检查质量控制方法,参考发达国家的参数放行指南,分析无菌药品参数放行优越性及具体实施方法。结果与结论:对于无菌药品,参数放行能够为最终产品提供更高水平的质量保证,其替代传统的质量控制方法是必然的趋势。
OBJECTIVE： To provide references for the improving of the quality control level for aseptic drug products. METHODS： The advantages of parametric release of aseptic drug products and its enforcement were elucidated by comparing it with the traditional quality control technique and referring to parametric release guideline of developed countries. RESULTS ＆ CONCLUSIONS： Parametric release could provide high- level quality assurance for aseptic drug products. It is inevitable for parametric release to substitute the traditional quality control technique.
出处
《中国药房》
CAS
CSCD
北大核心
2008年第4期248-251,共4页
China Pharmacy
