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华R九X污染控制策略（CCS）风险评估报告-微生物.pdf

华R九X污染控制策略（CCS）风险评估报告-微生物.pdf

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    XXXXX药业有限公司

    XX车间污染控制策略（CCS）-微生物

    文件参与人员：

    页码：第1页/共66页

    项目

    姓名/职位签名/日期职责

    人员

    起草人起草

    审核人审核

    审核人审核

    审核人审核

    审核人审核

    审核人审核

    审核人审核

    批准人批准

    页码：第2页/共66页

    目录

    1目的·····································································································4

    2范围·····································································································4

    3职责······································································································4

    4参考文件································································································5

    5基本信息······························································································5

    6风险评估································································································9

    7新评估风险点汇总及改进计划····································································9

    页码：第3页/共66页

    1.目的

    根据现有无菌粉针剂生产工艺，对本公司XX车间厂房设施、公用系统、人员、物料等方面进行污染源分析，

    根据识别出来的污染源，评估现有控制和监测措施的有效性，确认措施是否足够或者需要重新制定措施，进一步完

    善现有无菌保障体系。

    EUGMP附录1无菌产品的生产-2020年第二次征求意见稿2.4项下描述：污染控制策略和用于降低来

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