長期停產產品或只生產了幾個批次，需要每年進行產品質量回顧（PQR）嗎？

留在家里 2025-05-08 發布于浙江

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Switzerland: Update of the Technical Interpretation on the PQR

瑞士：PQR 技術解釋更新

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 的技術解釋 I-SMI.TI.14e描述了檢查員在對藥品生產商、原料藥（API）生產商或上市許可持有人進行檢查時，對產品質量回顧（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 中描述和定義了進行年度產品質量回顧的重要性和要求。PQR 是檢查生產過程一致性的關鍵文件。

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.

該文件的第 5 章中介紹了這些變化。此外，還明確了生產商和上市許可持有人之間準備和評估PQR 的責任。

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.

如果只生產了幾個批次（或沒有生產），則準備 PQR 的間隔已從 5 年縮短到 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 應至少每年一次。每年的周期可以獨立于日歷年設置，即不一定從 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.

回顧的時間范圍可以根據生產持續時間進行適當調整，并充分論證。應在 SOP 中建立時間框架標準。如果當年沒有生產批次或生產批次很少，則回顧周期可能超過1 年。為此類情況選擇的回顧周期應至少包括 5 個批次。對于在回顧期間生產的批次很少的產品，可以考慮與其他產品進行合理的分組。趨勢分析可以包括從上一周期收集的結果，以確保其穩健性。

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).

在任何情況下，即使沒有生產或只生產了很少的批次，也應最遲在 3 年后進行PQR，并且應涵蓋相關方面（例如，回顧上市許可變更、穩定性試驗的結果、與質量相關的退貨、投訴和召回、糾正措施的充分性，委外活動）。

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.

同樣，如果在質量和管理回顧（例如管理評審）期間注意到特殊情況，例如關于穩定性結果、退貨、召回、投訴和/或偏差的負面趨勢（包括由確認和驗證活動引起的偏差）或監管問題，即使沒有生產或很少生產批次，也應進行PQR。應包括對上一個 PQR 所定義措施進行回顧。

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（平行進口產品）是全新的：盡管平行進口產品的上市許可持有人通常無法獲得藥品制造商的 PQR，但他應確認產品始終符合上市許可中規定的要求，并且他應具有標準操作程序中描述的程序，以便對平行進口產品的特定方面進行質量回顧（例如，投訴、召回、質量缺陷）。