In this example, for clarity, we left some of the validation inside the test method.
在本示例中,为了清晰起见,我们将验证的某些部分放在了测试方法内部。
Responsible for implementing validation work about all kinds of analysis method within Lab, supply the test support on the other validation work such as process, equipment, environment and etc.
负责实验室内部各种检验分析方法的验证工作的实施,对生产工艺、设备、生产环境等验证工作提供检验支持。
Result the method can compatible with the validation test of Chinese Pharmacopoeia 2005 version.
结果本方法满足中国药典2005版验证试验的基本要求。
Result: the method can pass the validation test of Chinese pharmacopoeia 2005 version.
结果:本方法满足中国药典2005年版验证试验的基本要求。
METHOD The validation have been tested by microbial recovery from 164 new drugs and the availability was estimated by the ratio of recovery from the test group to the control group.
方法以对照菌回收为主要内容,进行了16 4个新药产品的验证试验,用样本组和对照组之间的回收率对有效性进行评价。
The validation results showed that the method can be used for microbial limit test of compound paracetamol and amantadine hydrochloride tablets and capsules.
经方法学验证试验得出的检查方法可用于复方氨酚烷胺片剂、胶囊剂和颗粒剂的微生物限度检查。
Conclusion According to the bacteriostasis of products, the appropriate test method can be selected through the methodology validation.
结论根据样品的抑菌性,通过方法学验证选择合适的检验方法。
Conclusion According to the bacteriostasis of products, the appropriate test method can be selected through the methodology validation.
结论根据样品的抑菌性,通过方法学验证选择合适的检验方法。
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