近日，瑞士药监局发布了关于《产品质量回顾的技术解释》，其中提及关于产品质量回顾的完成期限——制造商应在回顾周期结束后的6个月内完成，而MAH对PQR的评价和评估则应最迟在回顾周期结束后12 个月内并在新的回顾周期开始前完成（两者取其最严）。

 

The PQR should be established in a timely manner by the manufacturer. “Timely” is considered as within 6 months after the end of the review period.

制造商应及时进行PQR。「及时」是指在回顾周期结束后的6 个月内完成。

 

The evaluation and assessment of the FP PQR by the MAH should be completed at the latest 12 months after the end of the reviewed period and before the start of the new review period (whatever occurs before).

MAH 对成品PQR 的评价和评估应最迟在回顾周期结束后12 个月内并在新的回顾周期开始前完成（两者取其最严）。

 

此外，文件中还提及对产品质量回顾周期的要求：

 

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。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。

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。

如存在负面趋势或监管问题，即使没有生产或很少生产批次，也应进行PQR。

 

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。

来源：Internet

关键词： 药品