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近日，瑞士藥監(jiān)局發(fā)布了關(guān)于《產(chǎn)品質(zhì)量回顧的技術(shù)解釋》，其中提及關(guān)于產(chǎn)品質(zhì)量回顧的完成期限——制造商應(yīng)在回顧周期結(jié)束后的6個(gè)月內(nèi)完成，而MAH對(duì)PQR的評(píng)價(jià)和評(píng)估則應(yīng)最遲在回顧周期結(jié)束后12 個(gè)月內(nèi)并在新的回顧周期開始前完成（兩者取其最嚴(yán)）。

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.

制造商應(yīng)及時(shí)進(jìn)行PQR。「及時(shí)」是指在回顧周期結(jié)束后的6 個(gè)月內(nèi)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 對(duì)成品PQR 的評(píng)價(jià)和評(píng)估應(yīng)最遲在回顧周期結(jié)束后12 個(gè)月內(nèi)并在新的回顧周期開始前完成（兩者取其最嚴(yán)）。

此外，文件中還提及對(duì)產(chǎn)品質(zhì)量回顧周期的要求：

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。應(yīng)在 SOP 中建立時(shí)間框架標(biāo)準(zhǔn)。

如果當(dāng)年沒有生產(chǎn)批次或生產(chǎn)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(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。

即使沒有生產(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。

如存在負(fù)面趨勢或監(jiān)管問題，即使沒有生產(chǎn)或很少生產(chǎn)批次，也應(yīng)進(jìn)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 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)年沒有生產(chǎn)批次或生產(chǎn)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(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（包括由確認(rèn)和驗(yàn)證活動(dòng)引起的偏差）或監(jiān)管問題，即使沒有生產(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。