Switzerland: Update of the Technical Interpretation on the PQR

瑞士：PQR 技术解释更新

 

Swissmedic's Technical Interpretation I-SMI.TI.14e describes the minimum expectations for the preparation and assessment of a Product Quality Review (PQR) that inspectors may have during an inspection of a manufacturer of medicinal products, a manufacturer of active pharmaceutical ingredients (APIs) for medicinal products or a marketing authorisation holder.

 

Swissmedic 的技术解释 I-SMI.TI.14e描述了检查员在对药品生产商、原料药（API） 生产商或上市许可持有人进行检查时，对产品质量回顾（PQR）的最低要求。

 

The importance and requirements for conducting annual Product Quality Reviews are described and defined in the Guide to Good Manufacturing Practice for Medicinal Products, Part I and Part II (Eudralex Vol. 4), and the PIC/S document PE 009. The PQR is a key document for checking the consistency of a manufacturing process.

 

GMP第 I 部分和第 II 部分（Eudralex 第 4 卷）以及PIC/S 文件 PE 009 中描述和定义了进行年度产品质量回顾的重要性和要求。PQR 是检查生产过程一致性的关键文件。

 

The changes are described in chapter 5 of thecurrent version 7.0. Among other things, responsibilities for the preparation and evaluation of the PQR between the manufacturer and the marketing authorisation holder are clarified.

 

该文件的第 5 章中介绍了这些变化。此外，还明确了生产商和上市许可持有人之间准备和评估PQR 的责任。

 

The interval for preparing a PQR if only a few batches have been produced (or no production has taken place) has been reduced from 5 years to 3 years.

 

如果只生产了几个批次（或没有生产），则准备 PQR 的间隔已从 5 年缩短到 3 年。

 

The PQR should be established at least annually. The yearly periods may be set independently from the calendar year, i.e. not necessarily from January to December.

 

PQR 应至少每年一次。每年的周期可以独立于日历年设置，即不一定从 1 月到 12 月。

 

Review timeframes can be appropriately adjusted based upon manufacturing and campaign duration with adequate justification. The timeframe criteria should be established in a SOP. Where no or very few batches were produced during the year, the review period might be longer than 1 year. The chosen review period for such cases should include at least 5 batches. For those products with very few batches produced during a review period, a reasonable grouping with other products might be considered. The trend analysis can include results gathered from the previous period to ensure its robustness.

 

回顾的时间范围可以根据生产持续时间进行适当调整，并充分论证。应在 SOP 中建立时间框架标准。如果当年没有生产批次或生产批次很少，则回顾周期可能超过1 年。为此类情况选择的回顾周期应至少包括 5 个批次。对于在回顾期间生产的批次很少的产品，可以考虑与其他产品进行合理的分组。趋势分析可以包括从上一周期收集的结果，以确保其稳健性。

 

In any case, the PQR should be performed at latest after 3 years even if no production has taken place, or only very few batches have been produced, and should cover the relevant aspects (e. g. review of marketing authorisation variations, results of the stability monitoring programme, quality-related returns, complaints and recalls, adequacy of corrective actions, contractual arrangements).

 

在任何情况下，即使没有生产或只生产了很少的批次，也应最迟在 3 年后进行PQR，并且应涵盖相关方面（例如，回顾上市许可变更、稳定性试验的结果、与质量相关的退货、投诉和召回、纠正措施的充分性，委外活动）。

 

Likewise, if during the quality and regulatory review (e. g. the Management Review) a special situation has been noticed e. g. regarding stability results, returns, recalls, negative trends with respect to complaints and/or deviations (including those arising from qualification and validation activities) or regulatory issues, a PQR should be established even if no or very few batches have been produced. A review of the defined actions of the last PQR should be included.

 

同样，如果在质量和管理回顾（例如管理评审）期间注意到特殊情况，例如关于稳定性结果、退货、召回、投诉和/或偏差的负面趋势（包括由确认和验证活动引起的偏差）或监管问题，即使没有生产或很少生产批次，也应进行PQR。应包括对上一个 PQR 所定义措施进行回顾。

 

Chapter 4.6 (Parallel imported products) is completely new: Even though the marketing authorisation holder of a parallel imported product usually does not have access to the PQR of the manufacturer of the product, he should however verify that the product consistently complies with the requirements laid down in the marketing authorisation and he should have a procedure described in a standard operating procedure to conduct a quality review of specific aspects for parallel imported products (i.e. complaints, recalls, quality deficiencies).

 

第 4.6 章（平行进口产品）是全新的： 尽管平行进口产品的上市许可持有人通常无法获得药品制造商的 PQR，但他应确认产品始终符合上市许可中规定的要求，并且他应具有标准操作程序中描述的程序，以便对平行进口产品的特定方面进行质量回顾（例如，投诉、召回、质量缺陷）。

来源：Internet

关键词： 药品