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volador

木虫 (正式写手)

老兔崽子

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虫号: 68668
注册: 2005-05-18
专业: 药物学其他科学问题

[交流] 产品年度审核SOP

Annual Product Review

1. POLICY STATEMENT 方针描述

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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