无菌检查之风险评估及规避_Olivier.pdfVIP

Risk Assessment Risk Mitigation in Sterility testing 无菌检查之风险评估及规避无菌检查之风险评估及规避 无菌检查之风险评估及规避无菌检查之风险评估及规避 Olivier MAZILLE, Global Product Manager - Sterility testing Gilles Aubut, Head of Product Management – Sterility testing 1. Sterility testing introduction无菌检查介绍 2. Risks assessment风险评估 Environmental considerations环境因素 Method considerations方法因素 Device Hardware设备及硬件 Media considerations培养基因素 3. Conclusions结论 Sterility Testing Introduction 无菌检查介绍无菌检查介绍 无菌检查介绍无菌检查介绍 Sterility Testing为何进行无菌检查为何进行无菌检查 为何进行无菌检查为何进行无菌检查 Why to conduct a sterility test ? GMP requirements “For each batch of drug product purporting to be sterile and/or pyrogen free, there shall be appropriate lab testing to determine conformance to such requirements” 21CFR211.167 (a) “对于每一批认为是无菌/无热源的药品，需要通过适当的 实验室检查来确定” 21CFR211.167 (a) EP7/USP33 „The test is applied to substances, preparations or articles which, according to the Pharmacopoeia, are required to be sterile.“ “药品无菌检查系用于检查药典要求无菌的药品、 医疗器具、原料、辅料及 其他品种是否无菌的一种方法” Sterility Testing What is the Test for Sterility ? 什么是无菌检查什么是无菌检查 什么是无菌检查什么是无菌检查 Presence / Absence test存在/不存在检查 Reference test参考性测试 Quality assurance requirement 质量保证要求 Represents one set of data which contributes to the decision of whether or not the product lot meets the stated claims. 代表一组数据，有助于我们判断产品是否达到所要求的那样 Not intended as a sole product release test 并不作为唯一的产品放行检查的标准 Sterility Testing Programs in Pharmaceutical Microbiology 制药微生物中无菌检查程序制药微生物中无菌检查程序 制药微生物中无菌检查程序制药微生物中无菌检查程序 Sterility Testing Microbiology Laboratory Environmental