LOGFILE Feature  –Batch Designation:Handwritten or Electronic?

批次信息：手寫(xiě)還是打印？

In our company,every step of the production process is documented on the batch processingrecord, which is printed out on paper beforehand. Prior to this, all batchesused were entered in the record by hand. This often resulted in an unclearspelling. In order to improve the documentation, it was suggested that thebatches be written on the computer. From a GMP point of view, is it correctthat the batch designation on the batch processing records iswritten on the computer instead of handwritten?

在我們公司，生產(chǎn)過(guò)程的每一步都記錄在預(yù)先打印的紙質(zhì)批記錄上。在此之前，所有批次信息都為手寫(xiě)。這通常會(huì)導(dǎo)致填寫(xiě)不清。為了改進(jìn)記錄，有建議在計(jì)算機(jī)上填入批次信息。從 GMP 的角度來(lái)看，是否允許在計(jì)算機(jī)上預(yù)先填入批記錄上的批次信息而不是手寫(xiě)？

This question, which at first glance seems simple, turns out to be quitetricky at second glance, because it all depends on the details. We havecompiled three detailed answers to this question - directly from the editorialoffice, from the perspective of a GMP inspector and a QA manager.

這個(gè)問(wèn)題乍一看似乎很簡(jiǎn)單，乍一看就相當(dāng)棘手，因?yàn)檫@完全取決于細(xì)節(jié)。我們從 GMP 檢查員和 QA 經(jīng)理和小編的角度給出三個(gè)詳細(xì)的答案。

According to our editor Doris Borchert the crux ofthe matter is that an approved manufacturing instruction is required beforeproduction can begin. All batch-specific data are usually entered in theseinstructions - including the batch numbers of the starting materials used.

我們的編輯Doris Borchert 表示，問(wèn)題的癥結(jié)在于，在開(kāi)始生產(chǎn)之前，需要有經(jīng)過(guò)批準(zhǔn)的生產(chǎn)指令。所有與此批次相關(guān)的數(shù)據(jù)通常都輸入到該指令中 - 包括使用的起始物料的批號(hào)。

This means that thebatch numbers concerned cannot be "written on the computer" duringpreparation or weighing, because the printed manufacturing instructions arealready available. In other words: the batch numbers would have to be knownalready if the batch-related manufacturing instructions were printed andapproved. If this is the case or can be guaranteed organizationally, there is nothing tobe said against including the batch number as a "default" in thebatch-related manufacturing instruction, so to speak. However, itshould then be possible to verify in some way that the specified batch numberwas actually used, e.g. by means of an additional control or signature field.

這意味著在預(yù)處理或稱量期間，相關(guān)的批號(hào)不能"寫(xiě)在計(jì)算機(jī)上"，因?yàn)榇蛴〉纳a(chǎn)指令已經(jīng)可用。換句話說(shuō)：如果已經(jīng)打印并批準(zhǔn)與批次相關(guān)的生產(chǎn)指令，應(yīng)該已經(jīng)知道了批號(hào)。如果是這種情況，或者如果可以在組織上保證，那么可以說(shuō)，在批處理相關(guān)的生產(chǎn)指令中將批號(hào)作為"默認(rèn)"，也無(wú)可厚非。但是，應(yīng)可以以某種方式確認(rèn)實(shí)際使用了指定的批號(hào)，例如通過(guò)額外的控制或簽名字段。

This answer is in line with the view of the GMPinspector, who writes the following on thesubject:

該答案與GMP檢查員的觀點(diǎn)一致：

Since most companies use appropriate enterprise resource planning systems(ERP systems), the manufacturing instruction usually includes an order-specificbillof material (BOM) created on the basis of the released general BOM.The BOM should contain the quantities of the individual components adapted tothe order size as well as the batch numbers of the components to be used. Thisexists in production, but also in packaging. Usually this document documentsthat the specified batches have been used, e.g. by the employee of the weighingcentre.

由于大多數(shù)公司使用適當(dāng)?shù)钠髽I(yè)資源計(jì)劃系統(tǒng)（ERP系統(tǒng)），因此制造指令通常包括根據(jù)已發(fā)布的總物料清單（BOM）創(chuàng)建的特定于訂單的物料清單（BOM）。BOM應(yīng)該包含適合于訂單大小的各個(gè)組分的量以及要使用的組分的批號(hào)。這不僅在生產(chǎn)過(guò)程中，也存在于包裝中。通常，此文件記錄了已使用（如由稱重中心的員工使用）的指定批次的信息。

The procedure would be as follows:

該程序應(yīng)如下：

Work     preparation creates the orders with all specifications. It is irrelevant     whether these specifications are made in a BOM as described above or     directly in the manufacturing instruction.

工作準(zhǔn)備創(chuàng)建具有所有規(guī)格的指令。這些規(guī)格是如上所述在BOM中產(chǎn)生的，還是直接在生產(chǎn)指令中產(chǎn)生，都無(wú)關(guān)緊要。

The order prepared in     this way must be released and can then be processed in a documented     manner.

以這種方式準(zhǔn)備的訂單應(yīng)在釋放后可以以記錄的方式處理。

Both answers confirm that the batch numbers can be preset (and thusentered on the PC), provided that the conformity of the batch used with thepreset batch number is confirmed again during processing.

兩個(gè)答案都確認(rèn)批號(hào)可以預(yù)先設(shè)置（在 PC 上輸入），前提是在處理過(guò)程中再次確認(rèn)與預(yù)設(shè)批號(hào)的一致性。

The answer of the head of a QA, however, shows a different view of the problem.

但是，QA經(jīng)理的回答卻顯示出對(duì)該問(wèn)題的不同看法。

The batch numbers should not be entered in the "Word" document at file level and thus in the (approved) specification document, as theunchangeability, correctness, completeness, etc. of the batch numbers is notguaranteed. ALCOA would have to be questioned here.

批號(hào)不應(yīng)在文件級(jí)別的“ Word”文檔中輸入，也不能在（批準(zhǔn)的）標(biāo)準(zhǔn)文檔中輸入，因?yàn)椴荒鼙ＷC批號(hào)的不可更改性，正確性，完整性等。ALCOA將不得不在這里受到質(zhì)疑。

So, if the batch numbers are to be entered in the record and this cannotbe solved technically cleanly (here it was not about efficiency but only aboutreadability), I would try to design the template document in such a way that illegibilitiescan be minimized by design.

因此，如果要在記錄中輸入批號(hào)，而這在技術(shù)上無(wú)法徹底解決（此處不關(guān)效率，而僅關(guān)乎可讀性），我將嘗試設(shè)計(jì)模板文檔，以通過(guò)設(shè)計(jì)使出錯(cuò)率最小化。