工艺验证需要多少批次？

繁华洛尽

工艺验证需要多少批次？
来源：GMP办公室




　　How many lots or batches do I have to include in my process validation?


　　工艺验证需要包含多少批?


　　Process validation does not require a specific number of batches or lots. Many people believe they must use three lots to perform a process validation, but this isn't necessarily adequate. Instead, focus on including as many sources of variation as you expect to encounter in commercial production: multiple raw material batches, multiple suppliers, multiple operators, shifts, equipment, etc. Including these sources of variation will determine the number of lots required for your validation.


　　工艺验证并不要求具体数量的批次。许多人认为他们必须使用三批来进行工艺验证，但是这不是必须的。应该着重囊括尽可能多种在商业生产中可能会发生的变异源：如不同原料批次、不同供应商、不同操作人员、班次、设备等。这些变异源将决定你工艺验证的批次。


　　编写验证文件的4点技巧


　　To help you enhance your writing, we present four useful tips based on commonly found errors. You can place the next few points right into practice!


　　为了帮助大家编写方案，我们根据普遍发现的问题向大家推送了4条有用的技巧，供大家参考。


　　1. Have detailed Design Specifications.


　　有具体的设计规范


　　Design Specifications should precisely detail how Requirements will be met. Since they are the most technical of all of the documents, it is critical that material is placed in a logical manner. Using a template will help set the stage for Design Specifications that are functional and streamlined.


　　设计规范应该清晰明确要求是如何被满足的。技术资料是整个文件最技术性的问题，应以合理的方式列出。使用一个模板有助于为满足设计规范创造条件。


　　2. Figure out how many times your protocols will be executed.


　　算出你的方案将被使用多少次


　　The number of times you expect your protocol to be used should dictate how much time you should spend on making it efficient to executive. If the protocols will be executed numerously, take extra time to make them as efficient and effective as possible.


　　你的方案预计被使用的次数将决定你在其生效被执行前需要消耗的时间。如果该方案将会被无限次数的使用，可以花费多点时间以使其尽可能的有效和有用。


　　3. Avoid sloppy errors in test cases and get familiar with who is using your protocol.


　　在测试案例中避免提供错误，并且了解你的方案将是被谁使用的。


　　Who is going to be using your system? If it is someone not as familiar with your system, consider writing better procedures with more instructions. If you find a mistake in your reusable protocol or template, take time to correct it in the template before the text, in case it appears again the next time it is run.


　　谁将使用你的系统?如果是一些不是很熟悉你的系统的人，应考虑写入带有更多指导说明的程序。如果你在你的方案模板中发现一个错误，花点时间去纠正它，以免它在下次使用时再次出现。


　　4. Cut down on excessively long procedures.


　　减少过长的程序


　　Optimally, procedures shouldn’t be more than 5 sentences. If your steps are lengthy, break them up into 2-3 smaller steps.


　　程序最好不要超过5句。如果你的步骤太长，将他们分成2-3个小步骤。

xqliu

很好，谢谢提供分享。