Frequently Asked Questions on Deviations

关于偏差的常见问题

April 2, 2021

Susan J. Schniepp , StevenJ. Lynn

Pharmaceutical Technology, Pharmaceutical Technology-04-02-2021, Volume 45, Issue 4

美国制药技术杂志，2021-04-02期

Q. What is a deviation and do all deviations need to be investigated?

什么是偏差，所有偏差都需要调查吗?

A. A deviation is when there is a failure to follow the instructionsguiding the performance of how an activity should be executed for optimalresults. Simply put, deviations result from people not following their standardoperating procedures (SOP), work instructions, batch record instructions, orother documents that explain what needs to be done in performing certainfunctions or tasks. Deviations relate to non-compliance and are a seriousissue. While not all deviations are equal in their impact on product andquality, all should be investigated.

偏差是指没有按照指导如何执行一项活动以获得最佳结果的指示执行。简单地说，偏差是由于人员没有遵守他们的标准操作规程(SOP)、作业指导书、批记录指令或其他文件，这些文件解释了在执行某些功能或任务时需要做什么。偏差与不符合有关，是一个严重的问题。虽然不是所有的偏差对产品和质量的影响都是一样的，但是所有的偏差都应该被调查。

Q. What is a planned deviation?

什么是计划性偏差？

A. In our opinion, there is no suchthing as a planned deviation. Planned deviations were supposed to justifychanges from SOPs that would be utilized to carry out the operation over acertain period of time. The current thinking by regulatory authorities is thereis no such thing as a planned deviation. During a breakfast session at the 2018PDA/FDA Joint Regulatory Conference, a representative from the FDA stated,“it’s a very strange term, and it kind of makes your skin crawl a little bit”(1). If you need to make a change to a procedure for a short period of time, wesuggest you use the change control system to document the change. This may seemlike a picky point, but until the change is evaluated for its impact on theprocess validation requirements and formally documented in a change control,encouraging the deviation’s continued use is supporting a posture ofnon-compliance.

在我们看来，没有所谓的计划性偏差。计划性偏差是用以支持临时采取的超出SOP的做法的合理性。监管当局目前的想法是，没有所谓的计划性偏差。在2018年PDA/FDA联合监管会议上，FDA的一位代表表示:“这是一个非常奇怪的术语，它有点让你起鸡皮疙瘩。” 如果你需要临时对程序进行变更，我们建议使用变更控制系统来记录变更。这似乎有点吹毛求疵，但是如不对变更对工艺验证需求的影响进行评估并正式记录在变更控制中，而继续使用计划性偏差将出现不合规的情况。

Q. What’s the best process forinvestigating deviations?

偏差调查的最佳过程是什么?

A. There is no single best process forinvestigating deviations. The ultimate goal of deviation investigations is todetermine why something went wrong, what caused it to go wrong, and how toaddress the issue and prevent its recurrence. To achieve successful resolutionof deviations, keep the following general considerations in mind:

对于偏差调查，没有单一的最佳过程。偏差调查的最终目标是确定问题发生的原因、什么导致问题发生、以及如何解决问题并防止问题再次发生。为了成功地解决偏差，请记住以下几点:

A one-size investigation doesn’t fit all situations.     Simple errors require simple documentation while more serious deviations     require broader investigations.

单一的调查不可能适用于所有情况。简单的错误需要简单的记录，而更严重的偏差则需要更广泛的调查。

The best tool to have is inquisitiveness. Ask     yourself how far this deviation could extend.

最好的工具就是求知欲。问问你自己，这种偏差会延伸到什么程度。

Widen your perspective. Look for ways to relate, not     separate, similar issues.

扩大你的视角。寻找方法将相似的问题联系起来，而不是分离开来。

Human error is rarely a sufficient root cause.

人为错误很少是一个充分的根本原因。

Always verify information or your instincts and     never assume you are correct without proper data to support your     instincts.

对信息或直觉进行确认，在没有适当的数据来支持你的直觉的情况下，永远不要假设你是正确的。