LOGFILE Feature 16/2020 –Batch Designation:Handwritten or Electronic?
批次信息：手写还是打印？
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?
在我们公司，生产过程的每一步都记录在预先打印的纸质批记录上。在此之前，所有批次信息都为手写。这通常会导致填写不清。为了改进记录，有建议在计算机上填入批次信息。从 GMP 的角度来看，是否允许在计算机上预先填入批记录上的批次信息而不是手写？
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.
这个问题乍一看似乎很简单，乍一看就相当棘手，因为这完全取决于细节。我们从 GMP 检查员和 QA 经理和小编的角度给出三个详细的答案。
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.
我们的编辑Doris Borchert 表示，问题的症结在于，在开始生产之前，需要有经过批准的生产指令。所有与此批次相关的数据通常都输入到该指令中 - 包括使用的起始物料的批号。
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.
这意味着在预处理或称量期间，相关的批号不能"写在计算机上"，因为打印的生产指令已经可用。换句话说：如果已经打印并批准与批次相关的生产指令，应该已经知道了批号。如果是这种情况，或者如果可以在组织上保证，那么可以说，在批处理相关的生产指令中将批号作为"默认"，也无可厚非。但是，应可以以某种方式确认实际使用了指定的批号，例如通过额外的控制或签名字段。
This answer is in line with the view of the GMPinspector, who writes the following on thesubject:
该答案与GMP检查员的观点一致：
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.
由于大多数公司使用适当的企业资源计划系统（ERP系统），因此制造指令通常包括根据已发布的总物料清单（BOM）创建的特定于订单的物料清单（BOM）。BOM应该包含适合于订单大小的各个组分的量以及要使用的组分的批号。这不仅在生产过程中，也存在于包装中。通常，此文件记录了已使用（如由称重中心的员工使用）的指定批次的信息。
The procedure would be as follows:
该程序应如下：
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.
工作准备创建具有所有规格的指令。这些规格是如上所述在BOM中产生的，还是直接在生产指令中产生，都无关紧要。
The order prepared in this way must be released and can then be processed in a documented manner.
以这种方式准备的订单应在释放后可以以记录的方式处理。
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.
两个答案都确认批号可以预先设置（在 PC 上输入），前提是在处理过程中再次确认与预设批号的一致性。
The answer of the head of a QA, however, shows a different view of the problem.
但是，QA经理的回答却显示出对该问题的不同看法。
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.
批号不应在文件级别的“ Word”文档中输入，也不能在（批准的）标准文档中输入，因为不能保证批号的不可更改性，正确性，完整性等。ALCOA将不得不在这里受到质疑。
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，如果要在记录中输入批号，而这在技术上无法彻底解决（此处不关效率，而仅关乎可读性），我将尝试设计模板文档，以通过设计使出错率最小化。
