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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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