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【连续制造】上海药监局公开征求《上海市药品连续制造检查指南（征求意见稿）》意见（附全文）

发布时间：2026-11-06 00:00:00

作者：上海市药品监督管理局

阅读次数：50

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连续制造是药品生产模式的重大变革，对检查理念、检查方法和检查能力提出了全新要求。为贯彻《中华人民共和国药品管理法》《上海市药品和医疗器械管理条例》《药品生产监督管理办法》《药品检查管理办法（试行）》，衔接国家药监局《关于适用〈Q13：原料药和制剂的连续制造〉国际人用药品注册技术协调会指导原则的公告》（2023年第158号）要求，指导本市药品生产检查员科学、规范开展连续制造工艺现场检查，我局组织起草了《上海市药品连续制造检查指南（征求意见稿）》。为提高指南的科学性、适用性和可操作性，现向社会公开征求意见，欢迎社会各界提出意见和建议。

公开征集意见时间：2026年11月4日至2026年12月3日。请重点就以下方面提出意见：指南的适用范围与检查策略设计是否符合本市连续制造技术应用实际；12类风险的识别是否充分，风险分级与控制要求是否便于现场判断；检查要点与现行法律法规、药品生产质量管理规范及ICH Q13等指导原则的衔接是否准确；四类剂型的差异化要求是否契合各自工艺特点；以及其他需要修改完善的内容。

意见反馈渠道如下：

电子邮箱：ypaj@yjj.shanghai.gov.cn（邮件名称请注明：《上海市药品连续制造检查指南》反馈意见）；传真号码：021-63112359。

附件：

1.上海市药品连续制造检查指南（征求意见稿）.docx

2.反馈意见汇总表.docx


  上海市药品监督管理局

  2026年11月4日




基本 文件 流程 错误 SQL 调试
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