Frequently Asked Questions on Deviations

關于偏差的常見問題

April 2, 2021

Susan J. Schniepp , StevenJ. Lynn

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

美國制藥技術雜志，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.

偏差是指沒有按照指導如何執行一項活動以獲得最佳結果的指示執行。簡單地說，偏差是由于人員沒有遵守他們的標準操作規程(SOP)、作業指導書、批記錄指令或其他文件，這些文件解釋了在執行某些功能或任務時需要做什么。偏差與不符合有關，是一個嚴重的問題。雖然不是所有的偏差對產品和質量的影響都是一樣的，但是所有的偏差都應該被調查。

Q. What is a planned deviation?

什么是計劃性偏差？

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，沒有所謂的計劃性偏差。計劃性偏差是用以支持臨時采取的超出SOP的做法的合理性。監管當局目前的想法是，沒有所謂的計劃性偏差。在2018年PDA/FDA聯合監管會議上，FDA的一位代表表示:“這是一個非常奇怪的術語，它有點讓你起雞皮疙瘩。” 如果你需要臨時對程序進行變更，我們建議使用變更控制系統來記錄變更。這似乎有點吹毛求疵，但是如不對變更對工藝驗證需求的影響進行評估并正式記錄在變更控制中，而繼續使用計劃性偏差將出現不合規的情況。

Q. What’s the best process forinvestigating deviations?

偏差調查的最佳過程是什么?

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:

對于偏差調查，沒有單一的最佳過程。偏差調查的最終目標是確定問題發生的原因、什么導致問題發生、以及如何解決問題并防止問題再次發生。為了成功地解決偏差，請記住以下幾點:

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

單一的調查不可能適用于所有情況。簡單的錯誤需要簡單的記錄，而更嚴重的偏差則需要更廣泛的調查。

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。問問你自己，這種偏差會延伸到什么程度。

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

擴大你的視角。尋找方法將相似的問題聯系起來，而不是分離開來。

Human error is rarely a sufficient root cause.

人為錯誤很少是一個充分的根本原因。

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

對信息或直覺進行確認，在沒有適當的數據來支持你的直覺的情況下，永遠不要假設你是正確的。