An Annual Product Review must be conducted for each commercial Product. The purpose of this annual review is to verify the consistency of the process, to assess trends, to determine the need for changes in Specifications, Production, Manufacturing, and/or control Procedures and to evaluate the need for revalidation 每一种上市的药品都要做年度审核，年度审核的目的是验证生产工艺的连贯性，评估其趋势，确定在规范、生产、生产过程、和/或控制规程方面变更的必要性，并评估再验证的必要性
2. SCOPE 范畴
This Standard applies to all Company Sites and Affiliates. It includes all commercial Active Pharmaceutical Ingredients, Drug Product and Medical Devices Manufactured by or for Company. 这种标准适用于所有的药品生产企业及相应的附属机构，包括由公司生产或为公司生产的所有上市的原料药、药品以及医疗器械
3. RESPONSIBILITIES 职责
The Senior Site Quality Manager of the Company Site or External Manufacturing Unit that releases the Active Pharmaceutical Ingredient or Drug Product is responsible for ensuring that an Annual Product Review and the report for the Annual Product Review are completed. Where semi-finished product is processed in multiple Sites, all Sites must participate in the Annual Product Review process by supplying information to the Site of release. 负责放行原料药或药品的公司或外部生产工厂的高层质量管理人员，有责任确保完成年度产品审核以及年度产品审核的报告。在多处工厂加工的半成品，所有的工厂必须参与年度产品审核，并提供工厂放行的信息。
Individual departments, such as Industrial Technologies, API Engineering, Operations, Information Solutions, Validation, Quality, Compliance, Pharmacovigilance and Regulatory Affairs are responsible for providing data and participating in the Annual Product Review process. 其他单独的部门，例如工业技术部、原料药工程部、操作、信息处理、验证、质量、认证、药物警戒以及法规事务部有责任提供数据并参与年度产品审核过程。
The report for the Annual Product Review must be approved by the Senior Site Quality Manager at the Company Site or External Manufacturing Unit and distributed to Senior Site Management. 产品年度审核报告必须被公司质量部经理或是外部生产企业的质量部经理批准并分发给工厂高层管理人员。 4. REQUIREMENTS 要求
The Annual Product Review must include all Batches of Product whether they were accepted or rejected. 产品的年度审核必须包括所有批次的产品，无论是被接受还是被拒收的。
The Annual Product Review must cover a one-year period, but does not have to coincide with the calendar year. The review must be completed within sixty (60) business days of the close of the period. A report for the Annual Product Review must address the assessment of data, documents and electronic records reviewed. 产品的年度审核必须是覆盖一年的时间，但不必与日历的一年相一致。年度审核必须在这段时间过去后的60个工作日内完成。产品年度审核报告必须写明对数据，文件，及电子数据的评估。
The following details are important indicators of product quality, safety, purity or efficacy. The review must include, at a minimum: 下面的一些细节是对于产品质量，用药安全，纯度以及功效来说，都是相对重要的因素。这个审核必须且是至少包括这些方面： Review of any recommendations from prior report 以前报告的一些优点回顾。 Number of Batches Manufactured, including partially completed Batches 生产产品批次的数量，包括部分结束的批次 Number and percentage of Batches rejected and related reasons 出现问题的产品批次的数量及百分比，以及相关原因 Number and percentage of Batches reworked or reprocessed and related reasons 返工和再加工的产品批次的数量和百分比，以及相关原因 Deviations, Out of Specification Results and related Failure Investigations 偏差，OOS以及相关失败的调查结果 Environmental monitoring data (i.e. Product related, process related) 环境监测数据（包括与产品或是生产过程相关的） Product Specification/Method Changes 生产规范及方法的改变 Product quality complaints 产品质量投诉 Retained sample review for Drug Products 药品的留样观察 Trend analysis on release data 释放度数据变化趋势的分析 Trend analysis on stability data 稳定性数据变化趋势的分析 Changes effected (Change Control) 变化控制 Validation status 状态验证 Product Recalls or critical regulatory issues 产品的收回及关键的法规问题 Returned and/or salvaged goods 产品退回及补救 Observations/Recommendations from any official inspectorate 政府检查员的观察和建议 New recommendations from this review从这次审查中得出的新的意见
Additional items may be added to the review as necessary 在审核中需要添加的其他额外条款
The results of the Annual Product Review must be evaluated and an assessment made of whether corrective action or any re-validation is necessary. A conclusion statement must be written to assess if the Product consistently meets its quality attributes, and if not, what actions need to be taken. Rationale for such corrective actions must be documented. 产品年度审核的结果必须被评估，并要做出总结，是需要重新改正还是需要再验证，并要以书面的结论来说明该产品是否满足它的质量要求。如果不满足，需要采取什么新的措施。并且这种新的改正措施需要被证明。
Follow-up actions may include but are not limited to: 下面的部分应包括但不局限于以下几方面： Product process improvement 产品生产过程的改进 Formulation improvement 处方的改进 Analytical Method improvements 分析方法的改进 In-process or final product specification review过程或最终产品规范的审核 Revalidation 再验证 Product Recall or withdrawal. 产品的收回及退回
1 Objective目的 为了确认在现行的生产工艺及控制方法下所生产的产品符合规定的质量标准要求，每年度对所生产的每种产品相关内容与数据进行回顾，作出分析、评价和结论。 2 Scope 范围 本程序适用于所有在本公司内生产上市的产品和合同生产产品。 3 Responsibilities 职责 3.1 The QA is responsible for drafting, revising, reviewing, training, implementing and supervising this SOP. QA部负责本规程的起草、修订、审核、培训、实施和监督。 3.2 Quality Director is responsible for reviewing and approving this SOP. 质量总监负责本规程的审批。 3.3 Departments involved are responsible for reviewing and implementing this SOP. 相关部门负责本规程的审核与执行。 4 Definitions 定义 None 无
稳定性监控结果和任何不良趋势的审核(包括试验原因、含量趋势图、异常点分析、各检验项目趋势总结)。 Review of all batches that failed to meet established specification and their investigation.
所有不合格批次的审核及调查。
所有显著性偏差或不符合事件的审核和调查，及相应的整改和预防性措施的效果 审核（包括内容、原因、措施及结果）。 Statistic and analyze all reprocessed (only repackaged) products (including reasons, amounts and handling results).
返工产品（仅指重新包装）的统计及分析（包括原因、数量及处理结果）。
所有质量相关的退货、投诉和召回，以及当时的调查的审核（包括原因、数量及 处理结果）。
所有工艺或分析方法等变更的审核（包括内容、申请时间及执行情况）。
产品及其原辅料质量标准、内控标准及分析方法变更 Change of production facilities, equipment, batch size and processing parameters related to the product. 产品相关的生产设施、设备、批量及工艺参数的变更 Change of starting materials and packaging materials (including printed packaging material) relevant with the product. 与产品相关的原辅料、包装材料（含印字包材）的变更
产品相关的设备和设施如HVAC、水系统、压缩空气系统等的验证状态的审核。
产品的分析方法验证、工艺验证、清洁验证的验证状态的审核。
Review the adequacy of any other previous product process or equipment corrective actions.
Review technical agreements to ensure they are up to date.
技术协议的审核，以保证是现行的。
Review the effectiveness of results of the corrective & preventive measures in the last year’s review report.
上年度回顾报告中的纠正预防措施执行结果确认。
5.4 Quality Director should organize heads of the OSP, QC, QA, EQ, PQ, TD, and the production director to review the report, which is to be approved by the General Manager after passing the review.
质量总监组织相关人员包括生产部负责人、QC部负责人、QA部负责人、设备部负责人、工程部负责人、技术部负责人、生产总监等对该报告进行审核，审核通过后报总经理审批。 5.5 The QA distributes the reproduction of the approved annual quality review to departments concerned, the original copy are documented into the product archive and stored permanently in the document control center.
QA部将批准的年度产品质量回顾报告的复印件分发至各相关部门，原件归入产品质量档案，并在文件控制中心永久保存。 5.6 Concerned Departments effectively and timely implement reforming and corrective measures or other revalidation measures defined in the annual product quality review report. The QA department should track and collect the enforcing status of the above measures, which are to be presented in the next year’s product quality review report.
An Annual Product Review must be conducted for each commercial Product. The purpose of this annual review is to verify the consistency of the process, to assess trends, to determine the need for changes in Specifications, Production, Manufacturing, and/or control Procedures and to evaluate the need for revalidation 每一种上市的药品都要做年度审核，年度审核的目的是验证生产工艺的连贯性，评估其趋势，确定在规范、生产、生产过程、和/或控制规程方面变更的必要性，并评估再验证的必要性
2. SCOPE 范畴
This Standard applies to all Company Sites and Affiliates. It includes all commercial Active Pharmaceutical Ingredients, Drug Product and Medical Devices Manufactured by or for Company. 这种标准适用于所有的药品生产企业及相应的附属机构，包括由公司生产或为公司生产的所有上市的原料药、药品以及医疗器械
3. RESPONSIBILITIES 职责
The Senior Site Quality Manager of the Company Site or External Manufacturing Unit that releases the Active Pharmaceutical Ingredient or Drug Product is responsible for ensuring that an Annual Product Review and the report for the Annual Product Review are completed. Where semi-finished product is processed in multiple Sites, all Sites must participate in the Annual Product Review process by supplying information to the Site of release. 负责放行原料药或药品的公司或外部生产工厂的高层质量管理人员，有责任确保完成年度产品审核以及年度产品审核的报告。在多处工厂加工的半成品，所有的工厂必须参与年度产品审核，并提供工厂放行的信息。
Individual departments, such as Industrial Technologies, API Engineering, Operations, Information Solutions, Validation, Quality, Compliance, Pharmacovigilance and Regulatory Affairs are responsible for providing data and participating in the Annual Product Review process. 其他单独的部门，例如工业技术部、原料药工程部、操作、信息处理、验证、质量、认证、药物警戒以及法规事务部有责任提供数据并参与年度产品审核过程。
The report for the Annual Product Review must be approved by the Senior Site Quality Manager at the Company Site or External Manufacturing Unit and distributed to Senior Site Management. 产品年度审核报告必须被公司质量部经理或是外部生产企业的质量部经理批准并分发给工厂高层管理人员。 4. REQUIREMENTS 要求
The Annual Product Review must include all Batches of Product whether they were accepted or rejected. 产品的年度审核必须包括所有批次的产品，无论是被接受还是被拒收的。
The Annual Product Review must cover a one-year period, but does not have to coincide with the calendar year. The review must be completed within sixty (60) business days of the close of the period. A report for the Annual Product Review must address the assessment of data, documents and electronic records reviewed. 产品的年度审核必须是覆盖一年的时间，但不必与日历的一年相一致。年度审核必须在这段时间过去后的60个工作日内完成。产品年度审核报告必须写明对数据，文件，及电子数据的评估。
The following details are important indicators of product quality, safety, purity or efficacy. The review must include, at a minimum: 下面的一些细节是对于产品质量，用药安全，纯度以及功效来说，都是相对重要的因素。这个审核必须且是至少包括这些方面： Review of any recommendations from prior report 以前报告的一些优点回顾。 Number of Batches Manufactured, including partially completed Batches 生产产品批次的数量，包括部分结束的批次 Number and percentage of Batches rejected and related reasons 出现问题的产品批次的数量及百分比，以及相关原因 Number and percentage of Batches reworked or reprocessed and related reasons 返工和再加工的产品批次的数量和百分比，以及相关原因 Deviations, Out of Specification Results and related Failure Investigations 偏差，OOS以及相关失败的调查结果 Environmental monitoring data (i.e. Product related, process related) 环境监测数据（包括与产品或是生产过程相关的） Product Specification/Method Changes 生产规范及方法的改变 Product quality complaints 产品质量投诉 Retained sample review for Drug Products 药品的留样观察 Trend analysis on release data 释放度数据变化趋势的分析 Trend analysis on stability data 稳定性数据变化趋势的分析 Changes effected (Change Control) 变化控制 Validation status 状态验证 Product Recalls or critical regulatory issues 产品的收回及关键的法规问题 Returned and/or salvaged goods 产品退回及补救 Observations/Recommendations from any official inspectorate 政府检查员的观察和建议 New recommendations from this review从这次审查中得出的新的意见
Additional items may be added to the review as necessary 在审核中需要添加的其他额外条款
The results of the Annual Product Review must be evaluated and an assessment made of whether corrective action or any re-validation is necessary. A conclusion statement must be written to assess if the Product consistently meets its quality attributes, and if not, what actions need to be taken. Rationale for such corrective actions must be documented. 产品年度审核的结果必须被评估，并要做出总结，是需要重新改正还是需要再验证，并要以书面的结论来说明该产品是否满足它的质量要求。如果不满足，需要采取什么新的措施。并且这种新的改正措施需要被证明。
Follow-up actions may include but are not limited to: 下面的部分应包括但不局限于以下几方面： Product process improvement 产品生产过程的改进 Formulation improvement 处方的改进 Analytical Method improvements 分析方法的改进 In-process or final product specification review过程或最终产品规范的审核 Revalidation 再验证 Product Recall or withdrawal. 产品的收回及退回
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