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25 lines
996 B
Markdown
25 lines
996 B
Markdown
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# SOP 标准结构与章节要点
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## 通用结构（合并多来源的常见章节）
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1. **文档控制信息**：标题/编号、版本、修订记录、审批
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2. **目的（Purpose）**
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3. **范围（Scope）**
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4. **术语与定义（Definitions）**
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5. **职责（Responsibilities）**
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6. **程序/步骤（Procedures）**
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7. **记录与表单（Records / Forms）**
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8. **参考资料（References）**
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> 不同行业/机构会有不同细分，但以上内容是高频核心块。
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## 来源摘记
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### Boston University SOP Appendix（结构清单）
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- 包含 Purpose/Scope、References、Definitions、Responsibilities、Procedures、Records/Forms、Additional Considerations
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https://www.bu.edu/tech/files/2020/04/BU-ISCII-SOP-Appendix-2020.pdf
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### U.S. FDA SOP Template（章节目录）
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- 列出 Purpose、Scope、Policy、Responsibility、Procedures、References、Definitions、Exhibit、Revision History、Approval
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https://www.fda.gov/media/111941/download
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