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药品年度报告

最全合集!【质量回顾】法规解读、资料、课程内容合集

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1. 概述

质量回顾(Product quality review):是指企业针对一系列的生产和质量相关数据的回顾分析,以评价产品生产工艺的一致性,及相关物料和产品质量标准的适用性,以对其趋势进行识别并对不良趋势进行控制,从而确保产品工艺稳定可靠,符合质量标准的要求,并为持续改进产品质量提供依据。

2. 法规要求

第十章 质量控制与质量保证
第八节 产品质量回顾分析
第二百六十六条 应当按照操作规程,每年对所有生产的药品按品种进行产品质量回顾分析,以确认工艺稳定可靠,以及原辅料、成品现行质量标准的适用性,及时发现不良趋势,确定产品及工艺改进的方向。应当考虑以往回顾分析的历史数据,还应当对产品质量回顾分析的有效性进行自检。
当有合理的科学依据时,可按照产品的剂型分类进行质量回顾,如固体制剂、液体制剂和无菌制剂等。回顾分析应当有报告。
企业至少应当对下列情形进行回顾分析:
(一)产品所用原辅料的所有变更,尤其是来自新供应商的原辅料;
(二)关键中间控制点及成品的检验结果;
(三)所有不符合质量标准的批次及其调查;
(四)所有重大偏差及相关的调查、所采取的整改措施和预防措施的有效性;
(五)生产工艺或检验方法等的所有变更;
(六)已批准或备案的药品注册所有变更;
(七)稳定性考察的结果及任何不良趋势;
(八)所有因质量原因造成的退货、投诉、召回及调查;
(九)与产品工艺或设备相关的纠正措施的执行情况和效果;
(十)新获批准和有变更的药品,按照注册要求上市后应当完成的工作情况;
(十一)相关设备和设施,如空调净化系统、水系统、压缩空气等的确认状态;
(十二)委托生产或检验的技术合同履行情况。 第二百六十七条 应当对回顾分析的结果进行评估,提出是否需要采取纠正和预防措施或进行再确认或再验证的评估意见及理由,并及时、有效地完成整改。
第二百六十八条 药品委托生产时,委托方和受托方之间应当有书面的技术协议,规定产品质量回顾分析中各方的责任,确保产品质量回顾分析按时进行并符合要求。
(e) Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations and shall include provisions for:
(1) A review of a representative number of batches, whether approved or rejected, and, where applicable, records associated with the batch.
(2) A review of complaints, recalls, returned or salvaged drug products, and investigations conducted under 211.192 for each drug product.
Product Quality Review
1.10 Regular periodic or rolling quality reviews of all authorised medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to identify product and process improvements. Such reviews should normally be conducted and documented annually, taking into account previous reviews, and should include at least:
(i) A review of starting materials including packaging materials used in the product, especially those from new sources and in particular the review of supply chain traceability of active substances.
(ii) A review of critical in-process controls and finished product results.
(iii) A review of all batches that failed to meet established specification(s) and their investigation.
(iv) A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventive actions taken.
(v) A review of all changes carried out to the processes or analytical methods.
(vi) A review of Marketing Authorisation variations submitted, granted or refused, including those for third country (export only) dossiers.
(vii) A review of the results of the stability monitoring programme and any adverse trends.
(viii) A review of all quality-related returns, complaints and recalls and the investigations performed at the time.
(ix) A review of adequacy of any other previous product process or equipment corrective actions.
(x) For new marketing authorisations and variations to marketing authorisations, a review of post-marketing commitments.
(xi) The qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc.
(xii) A review of any contractual arrangements as defined in Chapter 7 to ensure that they are up to date.

2.4 WHO GMP

1.10 Regular, periodic or rolling quality reviews of all pharmaceutical products, including export-only products, should be conducted with the objective of verifying the consistency of the existing process and the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to identify product and process improvements.

3. 资源推荐

3.1 优质资源

年度产品质量回顾所需法规、资料及案例整理
https://zhiku.bopuyun.com/zhuanti/81609638895
年度质量回顾思维导图
https://zhiku.bopuyun.com/pc/resource/304744
产品年度质量回顾分析制度
https://zhiku.bopuyun.com/pc/resource/312423

3.2 优质文章

如何起草产品年度质量回顾
https://zhiku.bopuyun.com/pc/article/3758
质量回顾QA谈产品质量回顾分析
https://zhiku.bopuyun.com/pc/article/6554
持续工艺确认和产品年度质量回顾分析
https://zhiku.bopuyun.com/pc/article/5040

3.3 优质课程

四个统计学分析技巧,解决年度质量回顾分析难题
https://zhiku.bopuyun.com/pc/college/280
年度质量回顾-统计学干货-从基础概念到案例实操全面剖析
https://zhiku.bopuyun.com/pc/college/145

发布于 2022-08-08 15:14:12 © 著作权归作者所有