微生物实验室微生物数据偏离处理SOP（中英文版）.pdfVIP

Handling of Microbiological Data Deviation in MicrobiologyLaboratory 微生物实验室微生物数据偏离处理 SOP Objective: 目的 To lay down the procedure for Handling of MicrobiologicalData Deviation in Microbiology Laboratory. 制定微生物实验室微生物数据偏离处理程序 。 Scope: 范围 This procedure is applicable to environmental monitoringexcursions (namely Passive air sampling, Active air sampling, Surface sampling,Personnel monitoring, and Compressed gas monitoring)obtained during theEnvironmental monitoring, Sterility testing, Bacte rial Endotoxin Test,Bioburden, Microbial Limit test, Liquid borne particulate matter test,AET, CC-integrity tests and Water Samples. 本程序适用于环境监测（即沉降菌、浮游菌、表面微生物、人员监测和压缩空 气监测）、无菌检测、细菌内毒素检测、生物负载、微生物限度检测、液体颗 粒检测 、AET、CC 完整性测试和水样检测 。 Responsibility: 职责  Microbiologist is responsible for implementation of theprocedure and to report and carry out primary investigation .  微生物检验人员负责执行该程序，并报告和进行初步调查 。  Head Microbiology/Designee – Carryout investigation inmicrobiology section and ensure overall compliance of the SOP.  微生物主任：对微生物部分进行调查，并确保遵 循 SOP。  QA Executive/Designee -To assign the Microbiological datadeviation (MDD) Number as per standard operating procedures.  QA 主管：根据标准操作程序发放微生物数据偏离 （MDD）编号。  IPQA Executive/Designee – To carryout the investigation inmanufacturing area.  现场 QA 主管：对生产领域进行调查 。  Head production/designee -To support the investigation inmanufacturing area.  生产部长：配合生产领域的调查 。  Head Engineering /designee -To carryout the investigationin engineering related area.  工程部长：对工程相关领域进行调查 。 Head Quality assurance -To review the investigation inmicrobiology and manufacturing area. QA 经理：审核微生物和生产领域的调查。 Procedure: 程序 Definition: 定义 Laboratory error: An error that occurs in a Laboratoryassociated with the performance of a