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1、序号Q7 条款英文容中文容11Introduction介绍21.3Scope围3Has the company designated the point at which the production of the API begins?是否决定了API生产起点?4Can a rationale be provided for this decision?决定的理由？5Has the decision been discussed with the respective authority?是否与有关药政部门讨论过该决定6Are the quality critical steps ident
2、ified?是否确认了关键质量步骤72Quality Management质量管理82.1Principles原则92.11A 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)102.12Is there a quality policy?有无质量政策？11How is it brought to the attention of the employees?如何在员工中贯彻质量政策？1
3、2Is 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？13How does Management review effectiveness of quality system管理层如何了解质量体系的效果142.13Is the Quality Unit (QA/QC) independent of production?QA/QC是否独立于生产部门？152.1
4、4Is 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?16Who is the person(s)?谁是质量授权人？172.16Are all deviations documented and explained?是否所有偏差都有记录和解释?18Are critical deviations investigated in a timely manner?严重偏差是否及时进行调查？19Is there a written procedure for handling investig
5、ations (6.53)?是否有书面的调查程序？20Average days for completion?平均要调查几天？212.17How 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?22If 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？232.18How is managem
6、ent 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？24Average time needed for information?这种通知平均需要多少时间？252.2Responsibilities of the QUQU职责262.21Are there procedures that ensure that QU reviews and approves all quality related document
7、s?是否制定了确保QU审核批准与质量有关的所有文件？272.22Non-transferable responsibilities of QU:QU直接担负的责任：28release/rejection of APIs and IM (to be sold)IM和API的放行/拒绝29establish system to release/reject materials and labels建立物料和标签放行/拒绝的体系30review of critical process steps batch records审核批记录的关键工艺步骤31ensure critical deviation
8、s are investigated确保严重的偏离得到调查32approving specifications and master instructions批准质量标准和工艺规程33approving all quality related documents批准所有的有关质量的文件34ensuring conduction of internal audits确保进行自检35approving contract manufacturers批准合同制造商36approving changes with quality impact批准涉及质量的变更37approving validation
9、 documents批注验证文件38ensure complaints are resolved确保投诉得到处理39ensuring calibration system is functioning according to procedure executed确保校验工作按照既定程序进行40ensuring that stability data is generated and reviewed确保稳定性数据得以记录和审核41performing product quality reviews进行产品质量核查422.3Responsibilities for Production Act
10、ivities生产活动职责43procedure for preparing, reviewing and approving instructions起草，审核批准指令的程序44reviewing batch production records审核批生产记录45ensure all deviations and investigations are handled确保对所有偏差进行调查处理46cleaning of facilities设施得以清洗47calibrations performed校验得以进行48validation documents generated建立验证文件49ev
11、aluation of proposed changes评估变更申请50ensure that facilities and equipment are qualified确保设施仪器得以确认512.4Internal Audits自检52Are regular audits performed?是否定期自检？53Is there an audit schedule?有无自检计划？54Is the schedule followed?自检是否按计划进行？552.41Are audit findings and corrective actions documented?自检和改正行动是否有文件
12、记录？56Procedure to notify management of audit findings?向管理层通报自检结果的程序?57Are corrective actions completed within agreed time (are there significant delays?)是否按期改正（有无明显拖延？）582.5Product Quality Review产品质量审查592.50Are regular Product Quality Reviews conducted for all products?是否对所有产品进行了定期质量审查？60Frequency (
13、dedicated, campaign)?审查频率（常规进行，偶尔?）61Content (at least):审查至少包括下列容：62review of critical IPC and API test results审查关键中间体和API化验结果63review of all batches failed审查所有的不合格批次64review of all critical deviations审查所有的严重偏差65review of process changes and impact on quality审查工艺变更及其对质量的影响66review of changes to anal
14、ytical methods审查分析方法的变更67review of results of ongoing stability programmes审查正在进行的稳定性试验结果68review of returns, complaints, recalls审查退货，投诉，召回69review of adequacy of corrective actions defined in previous review审查过去的改正活动是否恰当702.51Evaluation and assessment for need of additional corrective actions to address recurring issues and/or need for process or cleaning revalidation评估对于反复出现得问题是否需要加大改正力度713Personnel人员723.1Personnel Qualifications人员确认733.10Adequate number of
