微生物实验室超标的调查.docxVIP

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 2.3 Environmental Monitoring investigations are very complex and it may not be possible to investigate the full extent of the excursion through a Laboratory Investigation. However, all excursions shall be investigated to discount an assignable cause of Laboratory Error. 环境监控的调查很复杂，很可能不能实验室调查中调查到超标的所有涉及到的因素。但应调查环境监控的因素以排查实验室的错误。 A site Environmental Monitoring Plan shall provide the guidance for a consistent investigative process related to excursions. The Environmental Monitoring Plan shall: 一个区域环境监控计划应提供与调查一致的指引。环境监控计划应： Provide a clear differentiation between Alert Limits and Action Limits 提供清晰的警戒限度和行动限度的区别。 Require identification of all organisms (genus and species if possible) involved in an Action Limit excursion with full tracking and trending of excursion data 为超标调查提供微生物鉴定以追溯及分析超标数据的趋势。 Provide guidance on notification to production, resampling requirements and timely closure of the investigation. 在向生产部发出的通知中提供指引、重取样要求和几时关闭调查。 3.0 Definitions 定义 Alert Limi