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Objective:

 

目的

 

To lay down the procedure for Handling of MicrobiologicalData Deviation in Microbiology Laboratory.

 

制定微生物實(shí)驗(yàn)室微生物數(shù)據(jù)偏離處理程序。

 

Scope:

 

范圍

 

This procedure is applicable to environmental monitoringexcursions (namely Passive air sampling, Active air sampling, Surface sampling,Personnel monitoring, and Compressed gas monitoring)obtained during theEnvironmental monitoring, Sterility testing, Bacterial Endotoxin Test,Bioburden, Microbial Limit test, Liquid borne particulate matter test,AET, CC-integrity tests and Water Samples.

 

本程序適用于環(huán)境監(jiān)測（即沉降菌、浮游菌、表面微生物、人員監(jiān)測和壓縮空氣監(jiān)測）、無菌檢測、細(xì)菌內(nèi)毒素檢測、生物負(fù)載、微生物限度檢測、液體顆粒檢測、AET、CC完整性測試和水樣檢測。

 

Responsibility:

 

職責(zé)

 

Microbiologist is responsible for implementation of theprocedure and to report and carry out primary investigation.

 

微生物檢驗(yàn)人員負(fù)責(zé)執(zhí)行該程序，并報告和進(jìn)行初步調(diào)查。

 

Head Microbiology/Designee – Carryout investigation inmicrobiology section and ensure overall compliance of the SOP.

 

微生物主任：對微生物部分進(jìn)行調(diào)查，并確保遵循SOP。

 

QA Executive/Designee -To assign the Microbiological datadeviation (MDD) Number as per standard operating procedures.

 

QA主管：根據(jù)標(biāo)準(zhǔn)操作程序發(fā)放微生物數(shù)據(jù)偏離（MDD）編號。

 

IPQA Executive/Designee – To carryout the investigation inmanufacturing area.

 

現(xiàn)場QA主管：對生產(chǎn)領(lǐng)域進(jìn)行調(diào)查。

 

Head production/designee -To support the investigation inmanufacturing area.

 

生產(chǎn)部長：配合生產(chǎn)領(lǐng)域的調(diào)查。

 

Head Engineering /designee -To carryout the investigationin engineering related area.

 

工程部長：對工程相關(guān)領(lǐng)域進(jìn)行調(diào)查。

 

Head Quality assurance -To review the investigation inmicrobiology and manufacturing area.

 

QA經(jīng)理：審核微生物和生產(chǎn)領(lǐng)域的調(diào)查。

 

Procedure:

 

程序

 

Definition: 

 

定義

 

Laboratory error: An error that occurs in a Laboratoryassociated with the performance of a test procedure, calculation error anddilution error or due to laboratory equipment malfunction or failure.

 

實(shí)驗(yàn)室錯誤：實(shí)驗(yàn)室發(fā)生的與測試程序的性能、計算錯誤和稀釋錯誤或?qū)嶒?yàn)室設(shè)備故障或失效相關(guān)的錯誤。

 

Assignable cause: A scientifically justified explanationof the reason for an out-of specification or questionable test value uncoveredand documented during the investigation.

 

可歸屬的原因：在調(diào)查期間發(fā)現(xiàn)并記錄的OOS或可疑測試值的原因的科學(xué)合理解釋。

 

Alert Limit: Alert limits are intended to provide warningsof situations which merit investigation but not necessarily warrant correctiveaction. A series of excursions (3 alerts in a week in a particularmanufacturing area either by same monitoring technique or from any of themonitoring techniques) beyond Alert Limits should constitute an excursionbeyond an Action Limit.

 

警戒限：警戒限用于提供應(yīng)予以調(diào)查但不一定需要糾正措施的警報。頻繁超出警戒限（在特定生產(chǎn)區(qū)域一周 3 次超警戒）應(yīng)視為超行動限。

 

Action Limit: A limits that, when exceeded, indicates aprocess may have drifted from its normal operating condition. Excursions beyondAction limits require a documented investigation and corrective actions toprocesses. Excursions beyond Action limits do not normally requireconsideration of action on products except when those excursions occur in GradeA areas

 

行動限：一個限度，當(dāng)超出時，表示工藝可能偏離其正常狀態(tài)。超出行動限需要對工藝進(jìn)行書面的調(diào)查和糾正措施。超行動限通常不需要考慮對產(chǎn)品采取措施，除非發(fā)生在 A 級區(qū)域。

 

Negative controls: Negative controls that to be used toidentify a “false positive’’ test Result.

 

陰性對照：用于識別"假陽性"測試結(jié)果。

 

Whenever Microbiological data deviation results areobtained in below mentioned   test, analyst involved in testing, willimmediately inform the results to Head Microbiology/ Designee andMicrobiological data deviation will be logged as per bellow:

 

一旦在下述測試中得到微生物數(shù)據(jù)偏離結(jié)果，參與測試的分析師應(yīng)立即將結(jié)果通知微生物主任，微生物數(shù)據(jù)偏離應(yīng)按照以下管記錄：

 

Microbiological Data deviation Numbering procedure: QA Executive/Designeeto assign the Microbiological Data Deviation (MDD) Number as below

 

微生物數(shù)據(jù)偏離編號程序：QA人員分配微生物數(shù)據(jù)偏離（MDD）編號如下：

 

MDD/YY/XX

 

Where MDD Stands for Microbiological Data Deviation

 

MDD 代表微生物數(shù)據(jù)偏離

 

YY stands for year

 

YY表示年份

 

XX stands for Serial Number

 

XX表示序列號

 

A log book for all Microbiological Data Deviation (MDD)shall be maintained.

 

應(yīng)維護(hù)所有微生物數(shù)據(jù)偏離（MDD）的臺賬。

 

Once the Microbiological Data Deviation results have beenidentified Head Microbiology/Designee should timely investigate (Laboratoryinvestigation). There should be no preconceived assumptions as to the cause offailure. 

 

一旦確定微生物數(shù)據(jù)偏離結(jié)果，微生物主任應(yīng)及時調(diào)查（實(shí)驗(yàn)室調(diào)查）。對失敗的原因不應(yīng)有先入為主的假設(shè)。

 

Mention the results obtained and details of the findingslike the date of testing and date of observation, etc.

 

描述獲得的結(jié)果和結(jié)果的詳細(xì)信息，如測試日期和觀察日期等。

 

Head Microbiology/Designee will discuss the methodfollowed with the analyst; Review the analyst’s knowledge/ training andqualification for performing the test correctly. Investigate whether anyabnormal incidence was documented during the period when the test was carriedout e.g. certain obvious errors like spilling of the sample, error in transferof the sample, power failure of equipment (incubator, LAF etc).

 

微生物主任將討論檢驗(yàn)所采用的方法；審查檢驗(yàn)人員正確執(zhí)行測試的知識/培訓(xùn)和確認(rèn)。調(diào)查在進(jìn)行測試期間是否記錄了任何異常情況，例如樣品溢出、樣品轉(zhuǎn)移錯誤、設(shè)備電源故障（培養(yǎng)箱、LAF等）等明顯錯誤。

 

Procedure for Environmental monitoring excursions:

 

環(huán)境監(jiān)測偏離調(diào)查程序：

 

Action to be taken in case of Alert Limit Excursions

 

超警戒情況下需要執(zhí)行的操作

 

If the microbial counts are found to be more than or equalto the alert limit, log Microbiological Data Deviation (MDD) .

 

當(dāng)微生物計數(shù)大于或等于警戒限，應(yīng)記錄微生物數(shù)據(jù)偏離（MDD）。

 

Notify Head -Production and Head -QA through Notification.

 

通知生產(chǎn)負(fù)責(zé)人和QA經(jīng)理。

 

Notify the environmental monitoring excursions in oneworking day from the observation of the excursion.

 

應(yīng)在發(fā)現(xiàn)偏離情況的一個工作日內(nèi)通知。

 

Carry out the investigation .

 

進(jìn)行調(diào)查

 

Check for the working discipline and adherence to thestandard operating procedures.

 

檢查工作方法和標(biāo)準(zhǔn)操作程序的符合情況。

 

Impart training to the operators / technicians, ifrequired.

 

如果需要，對操作人員/技術(shù)人員進(jìn)行培訓(xùn)。

 

Observe the plate(s) of the next day for any evidence ofhigher count.

 

在第二天繼續(xù)觀察平皿，以確認(rèn)計數(shù)是否更多。

 

Check the HVAC system for differential positive pressure,power failure, tripping of HVAC system, any deviation made by the operatorworking in the respective area and Entry log register for any new entrant.Record the details.

 

檢查 HVAC 系統(tǒng)是否出現(xiàn)負(fù)壓、電源故障、HVAC 系統(tǒng)的跳閘、在該區(qū)域內(nèi)工作的操作員是否出現(xiàn)任何偏離以及是否有任何新的人員進(jìn)入。記錄詳細(xì)信息。

 

If the counts above the alert limits are observed i.e., 3alerts in a week in a particular manufacturing area either by same monitoringtechnique or from any of the monitoring techniques, consider it as action limitand proceed for investigation as per the instructions given under Action LimitExcursions.

 

如頻繁超警戒，在特定生產(chǎn)區(qū)域一周 3 次超出警戒限，應(yīng)視為超行動限，并按照超行動限進(jìn)行調(diào)查。

 

If out of alert limit results are observed in the criticaloperational area, then the sterility tubes/canisters shall be observed forevidence of any growth for the batch(s) manufactured on the day of the out ofalert limit observation. Sterility tubes/canisters of batches manufactured onthe previous days shall also be observed for any growth.

 

如果在關(guān)鍵操作區(qū)域發(fā)現(xiàn)超警戒結(jié)果，則應(yīng)觀察無菌檢查的試管/容器，以確認(rèn)超警戒當(dāng)天生產(chǎn)的批次是否有菌檢出。超警戒前幾天生產(chǎn)的產(chǎn)品無菌檢查試管/容器，也應(yīng)觀察是否有菌檢出。

 

Action to be taken in case of Action Limit Excursions.

 

超行動限情況下需要采取的措施：

 

If the microbial counts are found to be more than or equalto the action limit, log Microbiological Data Deviation (MDD).

 

如微生物計數(shù)大于或等于行動限，應(yīng)記錄微生物數(shù)據(jù)偏離（MDD）。

 

Notify Head -Production and Head -QA through Notification.

 

應(yīng)通知生產(chǎn)負(fù)責(zé)人和QA經(jīng)理。

 

Notify the environmental monitoring excursions in oneworking day from the observation of the excursion.

 

應(yīng)在發(fā)現(xiàn)偏離情況的一個工作日內(nèi)通知。

 

Stop production and hold the release of batchesmanufactured during this period (from the date of monitoring and till the dateof availability of investigation results)

 

停止生產(chǎn)并暫停在此期間生產(chǎn)的批次放行（從監(jiān)測之日起至調(diào)查結(jié)果出來）

 

Subject the area for disinfection and fumigation.

 

對該區(qū)域進(jìn)行消毒和熏蒸。

 

Carry out microbiological monitoring of the area forconsecutive three days after completion of fumigation.

 

熏蒸完成后對該地區(qū)進(jìn)行連續(xù)3天的微生物監(jiān)測。

 

The area shall be released for processing only afteravailability of satisfactory environment monitoring data for 3 consecutive daysafter the fumigation.

 

只有在熏蒸后連續(xù)3天獲得令人滿意的環(huán)境監(jiān)測數(shù)據(jù)后，才能使用該地區(qū)進(jìn)行生產(chǎn)。

 

All the batches manufactured during the period shall besubjected to the additional sampling and microbial analysis.

 

在此期間生產(chǎn)的所有批次均需進(jìn)行額外的取樣和微生物分析。

 

Check for the working discipline and adherence tothe standard operating procedures.

 

檢查工作情況和SOP遵守情況。

 

Impart training to the operators / technicians, ifrequired. 

 

如有需要，對操作人員/技術(shù)人員進(jìn)行培訓(xùn)。

 

Check the trends and observe the next day’s results.Review the testing conditions.

 

檢查趨勢并觀察第二天的結(jié)果。審核測試條件。

 

Review of physical Environment condition of the room

 

審查該房間物理環(huán)境狀況

 

Temperature

 

溫度

 

Relative humidity

 

相對濕度

 

Differential Pressure.

 

壓差

 

Non-Viable particle counts. 

 

懸浮粒子

 

The observed microorganisms to be subjected foridentification and shall be reviewed for the following:

 

所檢出的微生物應(yīng)進(jìn)行鑒定，并應(yīng)審查以下：

 

Type of isolate-bacteria, yeast, molds (genus, species ifrequired),

 

細(xì)菌、酵母、霉菌的種類（屬，必要時到種），

 

Is it a common environmental isolate?

 

是常見的環(huán)境分離菌嗎？

 

Probable source of isolate (air, operators, extraneous),

 

可能的來源（空氣、操作人員、外來的），

 

Was this isolate observed before?

 

以前有檢出過這種菌嗎？

 

Is it a laboratory contamination?

 

是實(shí)驗(yàn)室污染嗎？

 

Type of isolate observed whether the isolate is sporeformer or non sporulating organism.

 

檢出菌的類型是產(chǎn)芽孢微生物的還是不產(chǎn)芽孢微生物。

 

Whether the contaminant is observed in critical site (Areawhere the product, product contact surface or containers & closures areexposed) or non-critical site.

 

污染是在關(guān)鍵部位（產(chǎn)品接觸面或容器暴露的區(qū)域）還是非關(guān)鍵部位檢出。

 

Whether the contaminant is incidental (Excursion at onlyone location at a given time of exposure). 

 

污染是否是偶然的（一定時間內(nèi)只有一個偏離）。

 

Whether the contaminant is observed as airborne orresidual population over the surface of equipment/ floor/ wall.

 

是空氣中？還是設(shè)備表面/地板/墻壁？

 

Whether the excursion is gradually increased fromexceeding alert level to action level.

 

是否逐漸從超警戒限增長為超行動限。

 

Whether the excursion is repeatedly observed above alertlimit in a particular location or facility.

 

該偏離是否為在在特定位置或設(shè)施中反復(fù)超警戒限。

 

The investigation team shall recommend corrective andpreventive actions.

 

調(diào)查小組應(yīng)建議糾正和預(yù)防措施。

 

Any extra sampling if required, to evaluate the course ofaction, shall be discussed among the team and can be implemented.

 

小組應(yīng)討論并實(shí)施任何必要的額外取樣以評估需要采取的措施。

 

Manufacturing and investigation team to ensure appropriatecorrective actions recommended by QA.

 

生產(chǎn)和調(diào)查小組，確保 QA 建議采取適當(dāng)?shù)募m正措施。

 

Depending upon the identified probable cause take suitablecorrective measures to eliminate the cause.

 

根據(jù)確定的可能原因采取適當(dāng)?shù)募m正措施來消除原因。

 

If reasons found for the exceeding count are related toactivities in the area, cleaning, disinfection, spraying of disinfectant orfogging and fumigation shall be carried out.

 

如果偏離的原因與該區(qū)域內(nèi)的活動有關(guān)，應(yīng)當(dāng)進(jìn)行清潔、消毒、噴灑消毒劑或霧化及熏蒸。

 

Review HVAC System – air velocity, air changes and filterintegrity record of LAF and HEPA filters.

 

查看 HVAC 系統(tǒng)– LAF 和 HEPA 過濾器的風(fēng)速、換氣次數(shù)和過濾器完整性記錄。

 

Review of trend of the environmental monitoring data.

 

審查環(huán)境監(jiān)測數(shù)據(jù)的趨勢。

 

Perform additional cleaning, disinfections and fogging ifhigh counts are observed next day.

 

如果第二天觀察到高的數(shù)據(jù)，進(jìn)行額外的清潔、消毒和霧化。

 

Observe the sterility tubes for the evidence of anygrowth.

 

觀察產(chǎn)品無菌檢查試管以確認(rèn)是否有菌檢出。

 

The investigation reports shall be submitted to the HeadQA/Designee.

 

調(diào)查報告應(yīng)提交給QA經(jīng)理。

 

Quality Assurance Head shall review the investigationreport and, if required, he can call for the re-qualification of the area.

 

QA經(jīng)理應(yīng)審查調(diào)查報告，必要時，可以要求對該區(qū)域進(jìn)行再確認(rèn)。

 

These batches shall be released for dispatch only afterthe investigation is complete and it is confirmed that the batchesmanufacturing during this period are not affected.

 

這些批次只有在調(diào)查完成后才能放行，并應(yīng)確認(rèn)在此期間的批次生產(chǎn)不受影響。

 

All the investigations carried out shall be recorded inthe format. The copy of this investigation report shall be maintained withrespective batch manufacturing records.

 

所有進(jìn)行的調(diào)查應(yīng)進(jìn)行記錄。應(yīng)復(fù)印調(diào)查報告并與相應(yīng)的批記錄一同保存。

 

If the routine personnel monitoring results are foundexceeding the alert/action limits, the concerned person shall be re-trained,re-sampled at the earliest as part of the corrective action.

 

如果發(fā)現(xiàn)日常人員監(jiān)測結(jié)果超出警戒限/行動限，應(yīng)盡早對相關(guān)人員進(jìn)行再培訓(xùn)，重新取樣，作為糾正措施的一部分。

 

If a trend of over alert/action limits (routine personnelmonitoring) occurs, the person shall be completely re-certified or re-assignedto new duties outside the aseptic area as part of the corrective action.

 

如果出現(xiàn)頻繁超警戒/行動限（日常人員監(jiān)測）的趨勢，作為糾正措施的一部分，該人員應(yīng)完全重新確認(rèn)或重新分配到無菌區(qū)以外工作。

 

If any laboratory error is found in laboratoryinvestigation manager microbiology shall take appropriate corrective action& evaluate the impact on the out of limit results (OOL) obtained, ensuresthe CAPA & send the report to QA.

 

如果在實(shí)驗(yàn)室調(diào)查中發(fā)現(xiàn)了任何實(shí)驗(yàn)室錯誤，微生物主任應(yīng)采取適當(dāng)?shù)募m正措施并評估所獲得的超限結(jié)果（OOL）的影響，確保CAPA并將報告發(fā)至 QA。

 

If there is no laboratory error observed, for furtherinvestigation to be done in manufacturing by QA and Head production.

 

如果沒有觀察到實(shí)驗(yàn)室錯誤，QA 和生產(chǎn)經(jīng)理應(yīng)對生產(chǎn)過程進(jìn)行進(jìn)一步調(diào)查。

 

Note: If the excursions occur in the product contactsurfaces during batch manufacturing, consider the batch rejection.

 

注意：如果在批生產(chǎn)期間產(chǎn)品接觸面發(fā)生偏離，請考慮拒絕該批次。

 

As part of the investigation, if exhaustive monitoring isplanned in the areas, perform the monitoring as per an approved protocol. Theprotocol as a minimum shall contain the details like type of monitoring, theareas to be monitored, acceptance criteria, and the reporting formats

 

作為調(diào)查的一部分，如果計劃在該地區(qū)進(jìn)行詳盡的監(jiān)測，則根據(jù)批準(zhǔn)的方案進(jìn)行。該方案至少應(yīng)包含監(jiān)測類型、需要監(jiān)測的區(qū)域、接受標(biāo)準(zhǔn)和報告格式等詳細(xì)信息。