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Validation deviations are just a part of life when you are working through validation protocols and test scripts; it’s highly unlikely that you will ever complete a full validation project without raising the odd validation deviation here and there.

 

執(zhí)行驗(yàn)證方案或測(cè)試文檔的過(guò)程中，驗(yàn)證偏差會(huì)是其中的一部分；在完成一個(gè)完整的驗(yàn)證項(xiàng)目時(shí)，幾乎不可能不產(chǎn)生一些奇怪的驗(yàn)證偏差。

 

Simple Deviations

 

簡(jiǎn)單偏差

 

Simple deviations are usually classified as documentation or protocol errors, these errors are usually found prior to execution or are “obvious” errors or typos. These deviations have no impact on the validation and offer to real risk to the validation process.

 

簡(jiǎn)單偏差通常被歸類為文檔或方案錯(cuò)誤，這些錯(cuò)誤通常在執(zhí)行之前被發(fā)現(xiàn)，或者是“明顯的”錯(cuò)誤或打字錯(cuò)誤。這些偏差對(duì)驗(yàn)證沒有影響，沒有給驗(yàn)證過(guò)程帶來(lái)真正的風(fēng)險(xiǎn)。

 

Examples of simple deviations include:

 

簡(jiǎn)單偏差的示例包括：

 

Incorrect specification for product

 

產(chǎn)品標(biāo)準(zhǔn)不正確

 

Loss of power to the equipment being tested

 

被測(cè)試的設(shè)備斷電

 

Non Critical Deviations

 

非嚴(yán)重偏差

 

Non-critical deviations are errors in the protocol or execution of the validation which have no impact on the validation, there errors are normally found during or after the execution. It is good practice to carry out an assessment to determine if the deviation has any impact.

 

非嚴(yán)重偏差是方案或驗(yàn)證執(zhí)行中的錯(cuò)誤，對(duì)驗(yàn)證沒有影響，通常在執(zhí)行期間或之后發(fā)現(xiàn)錯(cuò)誤。最好的做法是進(jìn)行評(píng)估，以確定偏差是否有任何影響。

 

Examples of non-critical exceptions include:

 

非嚴(yán)重偏差的示例包括：

 

Operator not trained to perform the operation

 

操作人員未接受操作培訓(xùn)

 

Critical Deviations

 

嚴(yán)重偏差

 

Critical deviations are errors which have an impact on the validation, these errors are found during or after execution. It is good practice in this scenario to carry out an assessment to determine the impact if any.

 

嚴(yán)重偏差是對(duì)驗(yàn)證有影響的錯(cuò)誤，這些錯(cuò)誤在執(zhí)行期間或之后發(fā)現(xiàn)。在這種情況下，最好的做法是進(jìn)行評(píng)估，以確定是否有影響。

 

Examples of critical exceptions include:

 

嚴(yán)重偏差的示例包括：

 

Acceptance criterion failure

 

不符合接受標(biāo)準(zhǔn)

 

Deviation Process Flow

 

偏差處理流程

 

SME involvement throughout the deviation process is critical. A CAPA may not be needed for simple events, but consider a CAPA if there are many of them or the same ones repeatedly.

 

SME參與整個(gè)偏差過(guò)程至關(guān)重要。簡(jiǎn)單的事件可能不需要CAPA，但如果有許多事件或重復(fù)的相同事件，則考慮使用CAPA。

 

General Process Considerations

 

一般流程考慮

 

It is advisable to commence with the resolution process as soon as the event is observed. Involve the SME’s/QA throughout the process as appropriate and get agreement on next steps and/or results prior to execution, or after the completion. Immediately notify the relevant SME/QA if there is any potential Product/Material impact. Conduct a risk assessment to determine the impact and actions to be taken.

 

一旦觀察到事件，建議立即開始解決過(guò)程。在適當(dāng)?shù)那闆r下讓SME /QA參與整個(gè)過(guò)程，并在執(zhí)行前或完成后就后續(xù)步驟和/或結(jié)果達(dá)成一致。如果有任何潛在的產(chǎn)品/物料影響，立即通知相關(guān)的SME/QA。進(jìn)行風(fēng)險(xiǎn)評(píng)估，以確定影響和應(yīng)采取的措施。

 

Types of Deviations

 

偏差的類型

 

Typographical errors

 

排字錯(cuò)誤

 

These errors are found prior to execution or are “obvious” errors or typos.

 

這些錯(cuò)誤是在執(zhí)行之前發(fā)現(xiàn)的，或者是“明顯的”錯(cuò)誤或打字錯(cuò)誤。

 

External Issues

 

外部錯(cuò)誤

 

Failures caused by factors external to the process or system under test.

 

由被測(cè)試過(guò)程或系統(tǒng)的外部因素引起的故障。

 

Execution Errors

 

執(zhí)行錯(cuò)誤

 

Failures to follow instructions within the Test Document or referenced procedures.

 

未能遵循測(cè)試文檔或引用程序中的說(shuō)明。

 

Document Generation Errors

 

文件錯(cuò)誤

 

Incorrect detail in procedures, acceptance criteria or referenced documentation.

 

程序、接受標(biāo)準(zhǔn)或所引用文件中的細(xì)節(jié)不正確。

 

Acceptance Criteria Failures

 

不符合接受標(biāo)準(zhǔn)

 

Pre-defined acceptance criteria have not been achieved.

 

不符合既定的接受標(biāo)準(zhǔn)。

 

Should the Testing Stop?

 

是否應(yīng)該停止驗(yàn)證？

 

This is always a questions that raises a lot of debate within the validation testing world. The decision to stop a validation mid-execution is something that will cost of the company both time and money so a process needs to be in place to make a critical decision like this.

 

這是一個(gè)在驗(yàn)證測(cè)試領(lǐng)域引起很多爭(zhēng)論的問(wèn)題。在執(zhí)行過(guò)程中停止驗(yàn)證的決定將花費(fèi)公司的時(shí)間和金錢，因此需要一個(gè)適當(dāng)?shù)牧鞒虂?lái)做出這樣的關(guān)鍵決策。

 

Initially the Impact Score should be analysed to determine the severity of the deviation (Event severity X Testing Stage = Impact), then a consultation with the SEM’s and QA is required to see if they are willing to live with such a failure. Usually this will open more questions than it solves so be prepared to have your own timelines impacted as a result.

 

最初應(yīng)該分析影響的程度以確定偏差的嚴(yán)重程度（事件嚴(yán)重性X測(cè)試階段=影響），然后需要與SEM和QA商量，看看他們是否愿意忍受這樣的失敗。通常這會(huì)帶來(lái)比它解決的問(wèn)題更多的問(wèn)題，所以準(zhǔn)備好你自己的時(shí)間線會(huì)因此受到影響。

 

Example l

 

案例1

 

Deviation - Product temperatures are recorded during the validation run using 10thermocouples placed in the product, evenly distributed throughout the load and linked toa data logger. At the completion of the cycle, it is discovered that one of thethermocouples has fallen out of the product container it had been placed in.

 

偏差：在驗(yàn)證運(yùn)行期間使用放置在產(chǎn)品中的10個(gè)熱電偶記錄產(chǎn)品溫度，均勻分布在整個(gè)負(fù)載并連接到數(shù)據(jù)記錄器。在循環(huán)完成時(shí)，發(fā)現(xiàn)其中一個(gè)熱電偶從放置它的產(chǎn)品容器中掉了出來(lái)。

 

Investigation & corrective actions - The other 9 thermocouples have provided valid dataThe location of the thermocouple that fell out of the product container is assessed todetermine if this location is a "worst-case’location within the load. If it is a worst-caselocation, then repetition of the study may be warranted. If not, then it may be possible to write a rationale that explains why the missing data point does not negate the validation.

 

調(diào)查和糾正措施：其他9個(gè)熱電偶已提供有效數(shù)據(jù)。評(píng)估從產(chǎn)品容器中掉落的熱電偶的位置，以確定該位置是否為負(fù)載內(nèi)的“最差情況”位置。如果這是一個(gè)最差情況，那么重復(fù)研究可能是必要的。如果不是，那么可以論證解釋為什么丟失的數(shù)據(jù)點(diǎn)不會(huì)否定驗(yàn)證。

 

Example 2

 

案例2

 

Deviation - In the process validation of a solid oral dosage product, 3 samples are to betaken from each shift (beginning, middle and end) during compression. The compressionstep for the proposed batch size takes on average 8 shifts to complete. During validationbatch #2, the samples are forgotten during the night shift.

 

偏差-在固體口服制劑產(chǎn)品的工藝驗(yàn)證中，壓片過(guò)程中每班（開始、中間和結(jié)束）取3個(gè)樣品。驗(yàn)證的批量大小的壓片步驟平均需要8個(gè)班次才能完成。在驗(yàn)證第2批的過(guò)程中，夜班期間忘記取樣。

 

Investigation & corrective actions - A temporary corrective action is put in place toensure that all samples from all shifts are collected for the remainder of validation batch#2 and #3. It is determined that a sufficient amount of data has been obtained to allowextrapolation of the data to cover the 3 missing samples from validation batch #2.particularly since samples were neither the start nor the end of the batch. Had the missingsamples been from a potentially critical stage in the compression the deviation may haverequired a 4th batch to replace the missing samples.

 

調(diào)查和糾正措施-采取臨時(shí)糾正措施，以確保第2批剩余部分和第3批所有班次的樣品都被收集。確定已獲得足夠數(shù)量的數(shù)據(jù)，以允許對(duì)數(shù)據(jù)進(jìn)行外推，以覆蓋驗(yàn)證批#2中的3個(gè)缺失樣本。特別是因?yàn)闃悠芳炔皇桥蔚拈_始也不是結(jié)束。如果丟失的樣品來(lái)自壓片的潛在關(guān)鍵階段，則偏差可能需要第4批來(lái)替換丟失的樣品。