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Switzerland: Update of the Technical Interpretation on the PQR

瑞士：PQR 技術(shù)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(shù)解釋 I-SMI.TI.14e描述了檢查員在對(duì)藥品生產(chǎn)商、原料藥（API） 生產(chǎn)商或上市許可持有人進(jìn)行檢查時(shí)，對(duì)產(chǎn)品質(zhì)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(jìn)行年度產(chǎn)品質(zhì)量回顧的重要性和要求。PQR 是檢查生產(chǎn)過(guò)程一致性的關(guān)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(chǎn)商和上市許可持有人之間準(zhǔn)備和評(píng)估PQR 的責(zé)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(chǎn)了幾個(gè)批次（或沒(méi)有生產(chǎn)），則準(zhǔn)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(yīng)至少每年一次。每年的周期可以獨(dú)立于日歷年設(shè)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(shí)間范圍可以根據(jù)生產(chǎn)持續(xù)時(shí)間進(jìn)行適當(dāng)調(diào)整，并充分論證。應(yīng)在 SOP 中建立時(shí)間框架標(biāo)準(zhǔn)。如果當(dāng)年沒(méi)有生產(chǎn)批次或生產(chǎn)批次很少，則回顧周期可能超過(guò)1 年。為此類情況選擇的回顧周期應(yīng)至少包括 5 個(gè)批次。對(duì)于在回顧期間生產(chǎn)的批次很少的產(chǎn)品，可以考慮與其他產(chǎn)品進(jìn)行合理的分組。趨勢(shì)分析可以包括從上一周期收集的結(jié)果，以確保其穩(wěn)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(méi)有生產(chǎn)或只生產(chǎn)了很少的批次，也應(yīng)最遲在 3 年后進(jìn)行PQR，并且應(yīng)涵蓋相關(guān)方面（例如，回顧上市許可變更、穩(wěn)定性試驗(yàn)的結(jié)果、與質(zhì)量相關(guān)的退貨、投訴和召回、糾正措施的充分性，委外活動(dòng)）。

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(zhì)量和管理回顧（例如管理評(píng)審）期間注意到特殊情況，例如關(guān)于穩(wěn)定性結(jié)果、退貨、召回、投訴和/或偏差的負(fù)面趨勢(shì)（包括由確認(rèn)和驗(yàn)證活動(dòng)引起的偏差）或監(jiān)管問(wèn)題，即使沒(méi)有生產(chǎn)或很少生產(chǎn)批次，也應(yīng)進(jìn)行PQR。應(yīng)包括對(duì)上一個(gè) PQR 所定義措施進(jìn)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(jìn)口產(chǎn)品）是全新的： 盡管平行進(jìn)口產(chǎn)品的上市許可持有人通常無(wú)法獲得藥品制造商的 PQR，但他應(yīng)確認(rèn)產(chǎn)品始終符合上市許可中規(guī)定的要求，并且他應(yīng)具有標(biāo)準(zhǔn)操作程序中描述的程序，以便對(duì)平行進(jìn)口產(chǎn)品的特定方面進(jìn)行質(zhì)量回顧（例如，投訴、召回、質(zhì)量缺陷）。