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重磅发布——强生合资公司生测室OOSOOT调查中英对照
Purpose目的
To provide a standard procedure for the investigation of microbiological results that are Out-of-Specification (OOS), Out-of-Trend (OOT) and questionable, and disposition procedure for finished products Out-of-Specification occurred.
提供微生物实验室发生测试结果超标、超趋势和对测试结果有疑问的实验室调查,以及成品发生微生物超标时的处理程序。
Scope 范围
2.1 This sop apples the microbiology laboratory of.
本标准操作规程适用于。
2.2 This sop applies when suspect or aberrant results are generated during the following activities(but not limited to):
本操作规程适用于在以下(但不限于)实验或操作中出现可以或异常的结果:
Raw/auxiliary material testing 原辅料测试
In-process material testing 中间产品测试
Final product release testing 成品放行测试
Stability testing 稳定性测试
Process validation testing 工艺验证测试
Transfer of validated test methods into, within or between quality laboratories 质量实验室之间或内部已验证的实验方法的传递或引入
Microbial limit testing 微生物限度测试
Growth promotion testing 培养基生长支持测试
Environmental monitoring 环境监控
Water testing 水样测试
Microbial identification 微生物鉴定
Biological indicator testing 生物指示剂测试 |
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