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Batch Records: who needs to review?

批記錄：誰來審核？

The QualifiedPerson (QP) often reviews the batch documentation personallyprior to certification of a batch. But is the QP obliged to doso? No, because this is not a requirement.

質(zhì)量受權(quán)人 (QP) 通常在批放行之前親自審核批記錄。但 QP 是否有義務(wù)這樣做？不, 因?yàn)檫@不是要求。

Chapter 2 ofthe EU-GMP Guide (Personnel) states that a QP "must ensure that eachbatch has been manufactured and checked in compliance with the laws … and inaccordance with the requirements of the marketing authorisation."(2.6)

歐盟 GMP 指南第2章《人員》規(guī)定, QP“必須確保每批產(chǎn)品的生產(chǎn)和檢驗(yàn)都符合法律規(guī)定和上市許可的要求。”(2.6)

Chapter 4 ofthe EU-GMP Guide (Documentation) adds that "allrecords should be available to the Qualified Person" (4.27). Itdoesn't say that the QP must review them in any case. According to 4.20i abatch processing record must be approved "by the person responsible forthe processing operations".

歐盟GMP指南第四章《文件》規(guī)定 "所有記錄都應(yīng)能提供給質(zhì)量受權(quán)人" (4.27)。但它并沒有說 QP 在任何情況下都必須對它們進(jìn)行審查。根據(jù) 4.20 i, 批記錄必須得到 "對該工藝作業(yè)負(fù)責(zé)的人員" 的批準(zhǔn)。

Who shouldreview the batch documentatoion?

誰應(yīng)該審查批記錄？

The head of theProduction Department needs "to ensure that the production recordsare evaluated and signed by an authorised person" (2.7iii). So thefirst review has to be done by production personnel, a second one might be doneby a quality function that has the competence and is authorised to do so. Ashort review by assistants to the QP based on a checklist could be an option.Annex 16 to the EU-GMP Guidelines states that the QP is responsible forensuring that "all records are complete and endorsed by appropriatepersonnel" (1.7.11).  However, a "system should be inplace to indicate special observations and any changes to critical data"(4.27). So the QP should easily see if there have been any non-conformances orchanges in the manufacturing process before certifying a batch. The QP shouldalso be able to rely on the systems and know what is going on in production andquality control.

生產(chǎn)部門負(fù)責(zé)人需要 "確保生產(chǎn)記錄得到經(jīng)批準(zhǔn)人員的評估和簽署" (2.7iii)。因此, 必須由生產(chǎn)人員進(jìn)行初審, 然后可能由具有能力并獲得批準(zhǔn)的質(zhì)量人員來完成。QP 助理可根據(jù)一份檢查清單進(jìn)行簡短的審查。歐盟GMP附錄16規(guī)定, QP 有責(zé)任確保 "所有記錄完整并得到適當(dāng)人員的簽署" (1.7.11)。但是, "應(yīng)建立一個(gè)系統(tǒng)用于展示特定偏差和對關(guān)鍵數(shù)據(jù)的任何修改" (4.27)。因此, 在批放行之前, QP 必須能很容易地看到生產(chǎn)過程中是否有任何不符合項(xiàng)或變更。QP 還應(yīng)該能夠依靠這些系統(tǒng), 了解生產(chǎn)和質(zhì)量控制方面發(fā)生了什么。

The U.S. Foodand Drug Administration FDA sees the Quality Control Unit (QCU) as beingresponsible to "review records to assure that no errors haveoccurred" (CFR 211.22). The QCU also has the "responsibilityfor approving or rejecting all procedures or specifications." CFR211.192 requires that all drug product production and control records arereviewed and approved by the QCU to determine compliance with writtenprocedures before a batch is released or distributed.

美國FDA認(rèn)為, 質(zhì)量控制單元 (QCU) 負(fù)責(zé) "審查記錄, 以確保沒有發(fā)生錯(cuò)誤" (CFR211.22)。QCU 還 "負(fù)責(zé)批準(zhǔn)或拒絕所有規(guī)程或標(biāo)準(zhǔn)"。CFR 211.192 要求所有藥品生產(chǎn)和控制記錄都經(jīng)過 QCU 的審查和批準(zhǔn), 以確定在批放行或分發(fā)之前是否符合書面規(guī)程。

By the way,according to Chapter 4, batch documentation must be kept at least five yearsafter certification of the batch by the Qualified Person (or for one year afterexpiry of the batch, whichever is longer).

同時(shí), 根據(jù)第4章, 批記錄必須在質(zhì)量受權(quán)人放行之后至少保存五年 (或有效期后一年, 以較長者為準(zhǔn))。