中英文版APIC原料药厂GMP审计表.docVIP

序号 Q7 条款 英文内容 中文内容 1 1 Introduction 介绍 2 1.3 Scope 范围 3 　 Has the company designated the point at which the production of the API begins? 是否决定了API生产起点? 4 　 Can a rationale be provided for this decision? 决定的理由？ 5 　 Has the decision been discussed with the respective authority? 是否与有关药政部门讨论过该决定 6 　 Are the quality critical steps identified? 是否确认了关键质量步骤 7 2 Quality Management 质量管理 8 2.1 Principles 原则 9 2.11 A Certified Quality Management System (e.g. ISO 9001) is implemented? (if yes, see chapter 20) 质量管理系统是否通过认证（例如ISO9001）? (已通过者参见第20章) 10 2.12 Is there a quality policy? 有无质量政策？ 11 　 How is it brought to the attention of the employees? 如何在员工中贯彻质量政策？ 12 　 Is there a Quality Manual or equivalent documentation that describes in detail how the Quality System is implemented? 是否有质量手册一类的文件来详细说明如何贯彻运作质量体系？ 13 　 How does Management review effectiveness of quality system 管理层如何了解质量体系的效果 14 2.13 Is the Quality Unit (QA/QC) independent of production? QA/QC是否独立于生产部门？ 15 2.14 Is there an authorized person(s) for the release of IM and APIs? 是否由质量授权人放行IM和API? 16 　 Who is the person(s)? 谁是质量授权人？ 17 2.16 Are all deviations documented and explained? 是否所有偏差都有记录和解释? 18 　 Are critical deviations investigated in a timely manner? 严重偏差是否及时进行调查？ 19 　 Is there a written procedure for handling investigations (6.53)? 是否有书面的调查程序？ 20 　 Average days for completion? 平均要调查几天？ 21 2.17 How is it ensured that materials are not released or used before completion of evaluation by the QU? 如何保障未经质量部门（QU）完成评估的物料不会放行或使用? 22 　 If not done by QU: Is an appropriate system in place? 如何不是由质量部门（QU）负责此事。有否其它相应机构？ 23 2.18 How is management notified of serious GMP deficiencies, quality related complaints and/or product defects? 出现GMP偏离，质量投诉和产品缺陷，如何通知管理层？ 24 　 Average time needed for information? 这种通知平均需要多少时间？ 25 2.2 Responsibilities of the QU QU职责 26 2.21 Are there procedures that ensure that QU reviews and approves all quality related documents? 是否制定了确保QU审核批准与质量有关的所有文件？ 27 2.22 Non-transferabl