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Frequently Asked Questions on Deviations

關(guān)于偏差的常見(jiàn)問(wèn)題

April 2, 2021

Susan J. Schniepp , StevenJ. Lynn

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

美國(guó)制藥技術(shù)雜志，2021-04-02期

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

什么是偏差，所有偏差都需要調(diào)查嗎?

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.

偏差是指沒(méi)有按照指導(dǎo)如何執(zhí)行一項(xiàng)活動(dòng)以獲得最佳結(jié)果的指示執(zhí)行。簡(jiǎn)單地說(shuō)，偏差是由于人員沒(méi)有遵守他們的標(biāo)準(zhǔn)操作規(guī)程(SOP)、作業(yè)指導(dǎo)書、批記錄指令或其他文件，這些文件解釋了在執(zhí)行某些功能或任務(wù)時(shí)需要做什么。偏差與不符合有關(guān)，是一個(gè)嚴(yán)重的問(wèn)題。雖然不是所有的偏差對(duì)產(chǎn)品和質(zhì)量的影響都是一樣的，但是所有的偏差都應(yīng)該被調(diào)查。

Q. What is a planned deviation?

什么是計(jì)劃性偏差？

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.

在我們看來(lái)，沒(méi)有所謂的計(jì)劃性偏差。計(jì)劃性偏差是用以支持臨時(shí)采取的超出SOP的做法的合理性。監(jiān)管當(dāng)局目前的想法是，沒(méi)有所謂的計(jì)劃性偏差。在2018年P(guān)DA/FDA聯(lián)合監(jiān)管會(huì)議上，F(xiàn)DA的一位代表表示:“這是一個(gè)非常奇怪的術(shù)語(yǔ)，它有點(diǎn)讓你起雞皮疙瘩。” 如果你需要臨時(shí)對(duì)程序進(jìn)行變更，我們建議使用變更控制系統(tǒng)來(lái)記錄變更。這似乎有點(diǎn)吹毛求疵，但是如不對(duì)變更對(duì)工藝驗(yàn)證需求的影響進(jìn)行評(píng)估并正式記錄在變更控制中，而繼續(xù)使用計(jì)劃性偏差將出現(xiàn)不合規(guī)的情況。

Q. What’s the best process forinvestigating deviations?

偏差調(diào)查的最佳過(guò)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:

對(duì)于偏差調(diào)查，沒(méi)有單一的最佳過(guò)程。偏差調(diào)查的最終目標(biāo)是確定問(wèn)題發(fā)生的原因、什么導(dǎo)致問(wèn)題發(fā)生、以及如何解決問(wèn)題并防止問(wèn)題再次發(fā)生。為了成功地解決偏差，請(qǐng)記住以下幾點(diǎn):

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

單一的調(diào)查不可能適用于所有情況。簡(jiǎn)單的錯(cuò)誤需要簡(jiǎn)單的記錄，而更嚴(yán)重的偏差則需要更廣泛的調(diào)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。問(wèn)問(wèn)你自己，這種偏差會(huì)延伸到什么程度。

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

擴(kuò)大你的視角。尋找方法將相似的問(wèn)題聯(lián)系起來(lái)，而不是分離開來(lái)。

Human error is rarely a sufficient root cause.

人為錯(cuò)誤很少是一個(gè)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.

對(duì)信息或直覺(jué)進(jìn)行確認(rèn)，在沒(méi)有適當(dāng)?shù)臄?shù)據(jù)來(lái)支持你的直覺(jué)的情況下，永遠(yuǎn)不要假設(shè)你是正確的。