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