FDA檢查的注意事項(xiàng)分析

1、FDA 檢查的準(zhǔn)備和注意事項(xiàng)檢查的準(zhǔn)備和注意事項(xiàng)Preparation US FDA Inspection總體上需要考慮的問(wèn)題General considerations提問(wèn)技巧Questioning techniques回答問(wèn)題Answering questions你不應(yīng)該做的事情What you should not do不希望引起審計(jì)官關(guān)注的事項(xiàng)Unwanted attention在車(chē)間和實(shí)驗(yàn)室里的行為Behavior for the shop floor and laboratory每個(gè)員工的行為Behavior for everybodyAgenda綱要審計(jì)期間，對(duì)人際關(guān)系的應(yīng)對(duì)。如

2、果審計(jì)官不喜歡或喜審計(jì)期間，對(duì)人際關(guān)系的應(yīng)對(duì)。如果審計(jì)官不喜歡或喜歡我們團(tuán)隊(duì)中的某一主要人員時(shí)，我們需要做一些內(nèi)部歡我們團(tuán)隊(duì)中的某一主要人員時(shí)，我們需要做一些內(nèi)部調(diào)整。如果審計(jì)官不喜歡你，你也不要生氣或者覺(jué)得是調(diào)整。如果審計(jì)官不喜歡你，你也不要生氣或者覺(jué)得是對(duì)自己的一種冒犯，團(tuán)隊(duì)會(huì)對(duì)人員做適當(dāng)調(diào)整。對(duì)自己的一種冒犯，團(tuán)隊(duì)會(huì)對(duì)人員做適當(dāng)調(diào)整。 React to interpersonal relationships during the inspection. If the inspector dislikes / likes a key player of your team take app

3、ropriate internal actions. Dont be offended if the inspector doesnt like you! General considerations總體考慮總體考慮2. 注意審計(jì)是由檢查官主導(dǎo)的，而不是你。你可以管理協(xié)調(diào)注意審計(jì)是由檢查官主導(dǎo)的，而不是你。你可以管理協(xié)調(diào)檢查工作，但不要嘗試去控制它。檢查工作，但不要嘗試去控制它。Respect that the inspector is in charge and not you! Manage the inspection but do not try to take control of

4、it! General considerations總體考慮總體考慮3. 總是陪同在審計(jì)官身邊！總是陪同在審計(jì)官身邊！ Always escort the inspector!General considerations總體考慮總體考慮An inspector is someone who arrives after the battle and bayonets all the wounded ：4. 有時(shí)檢查官也會(huì)處于特殊情況下。他可能問(wèn)自己這些問(wèn)題有時(shí)檢查官也會(huì)處于特殊情況下。他可能問(wèn)自己這些問(wèn)題Consider that also the inspector is in an exce

5、ptional situation. He might ask himself the questions:l 我能做好嗎？我能做好嗎？l Will I perform well?l 我能達(dá)到我的目標(biāo)嗎？我能達(dá)到我的目標(biāo)嗎？l Will I achieve my objectives?l 如果被檢查的工廠(chǎng)有出人意料的反應(yīng)，我是否能應(yīng)對(duì)？如果被檢查的工廠(chǎng)有出人意料的反應(yīng)，我是否能應(yīng)對(duì)？l Will there be unexpected reactions and will I cope with them?l 我是否能信賴(lài)這個(gè)人所說(shuō)的話(huà)？我是否能信賴(lài)這個(gè)人所說(shuō)的話(huà)？l Can I rely o

6、n what this person is saying? General considerations總體考慮總體考慮1 、封閉式問(wèn)題 Closed Question提問(wèn)技巧提問(wèn)技巧Questioning Techniques一般回答這類(lèi)問(wèn)題的答案數(shù)目很少，經(jīng)常可以推測(cè)出來(lái)一般回答這類(lèi)問(wèn)題的答案數(shù)目很少，經(jīng)?？梢酝茰y(cè)出來(lái)So called because the number of possible answers is very small and often able to predict舉例舉例Example：Q： 變更控制程序是由變更控制程序是由QA批準(zhǔn)的嗎？批準(zhǔn)的嗎？Is the

7、change control procedure approved by Quality Assurance?A： 是是 或或 否否Yes or No.-不要給出其他很多回答或者信息，除非被要求繼續(xù)給出。不要給出其他很多回答或者信息，除非被要求繼續(xù)給出。Unlikely to give much information, therefore least appropriate for obtaining a quantity of information. -像這類(lèi)問(wèn)題，審計(jì)過(guò)程中多多關(guān)注其他人的回答，這樣可以做到前后回答像這類(lèi)問(wèn)題，審計(jì)過(guò)程中多多關(guān)注其他人的回答，這樣可以做到前后回答不矛盾。

8、不矛盾。Good to verify what other person has done, said or thinks危險(xiǎn)級(jí)別危險(xiǎn)級(jí)別Danger level：低：低low2、開(kāi)放式問(wèn)題、開(kāi)放式問(wèn)題Open Question這類(lèi)問(wèn)題常常有很多種答案，回答者可以選擇如何回答這類(lèi)問(wèn)題常常有很多種答案，回答者可以選擇如何回答.So called because the number of possible answers is great and person can choose response, 比如比如e.g. 問(wèn)題：變更控制問(wèn)題：變更控制SOP的批準(zhǔn)過(guò)程是什么？的批準(zhǔn)過(guò)程是什么？Q:

9、What is the approval process for SOPs such as Change Control? -越是開(kāi)放的問(wèn)題，獲得的信息在質(zhì)量和數(shù)量上就越豐富。越是開(kāi)放的問(wèn)題，獲得的信息在質(zhì)量和數(shù)量上就越豐富。The more open questions asked, the greater the quality and quantity of information received. -一般回答開(kāi)放式問(wèn)題，可以從一般回答開(kāi)放式問(wèn)題，可以從 誰(shuí)，做什么，在哪里，為什么，什么時(shí)誰(shuí)，做什么，在哪里，為什么，什么時(shí)候，以及怎么做候，以及怎么做出發(fā)來(lái)回答。出發(fā)來(lái)回答。-Typic

10、ally open questions start with: who, what, were, why, when and how.危險(xiǎn)級(jí)別危險(xiǎn)級(jí)別Danger level：低低/中等中等Low/Medium提問(wèn)技巧提問(wèn)技巧Questioning Techniques3、審計(jì)官為獲得更多信息設(shè)計(jì)的問(wèn)題Question design to get more information對(duì)開(kāi)放式問(wèn)題的追問(wèn)，對(duì)他感興趣的內(nèi)容提問(wèn)，獲得更多信息問(wèn)題：對(duì)開(kāi)放式問(wèn)題的追問(wèn)，對(duì)他感興趣的內(nèi)容提問(wèn)，獲得更多信息問(wèn)題：Follow-up to open questions, focus on area of int

11、erest and gives more information. 問(wèn)題：請(qǐng)告訴我再更改控制程序中一共有哪些不同類(lèi)型？問(wèn)題：請(qǐng)告訴我再更改控制程序中一共有哪些不同類(lèi)型？Q:Tell me more about the different types of change covered by your Change Control procedure?一般回答也可以從一般回答也可以從誰(shuí)，做什么，在哪里，為什么，什么時(shí)候，以及誰(shuí)，做什么，在哪里，為什么，什么時(shí)候，以及怎么做怎么做開(kāi)始。開(kāi)始。More fluent versions again begin with: who, what, wher

12、e, why, when and how.危險(xiǎn)級(jí)別：危險(xiǎn)級(jí)別： 中等中等Danger Level: Medium提問(wèn)技巧提問(wèn)技巧Questioning Techniques4、給我看實(shí)物、給我看實(shí)物 (show me)確認(rèn)問(wèn)題應(yīng)答的真實(shí)性確認(rèn)問(wèn)題應(yīng)答的真實(shí)性Verification of response being ask edquestion.對(duì)提出的對(duì)提出的封閉式問(wèn)題封閉式問(wèn)題的確認(rèn)的確認(rèn)- 有，還是沒(méi)有？有，還是沒(méi)有？Represents a closed questionthe item is either there or not there!使回答的人員感受到壓力使回答的人員感受

13、到壓力Puts person under pressure.可能需要時(shí)間來(lái)收集這些實(shí)物數(shù)據(jù)可能需要時(shí)間來(lái)收集這些實(shí)物數(shù)據(jù)Time maybe needed to gather data.太多太多給我看實(shí)物給我看實(shí)物往往是破壞性的，給人一種缺乏信任的感覺(jué)。往往是破壞性的，給人一種缺乏信任的感覺(jué)。Too many “show mes” can be disruptive and might demonstrate lack of trust.危險(xiǎn)級(jí)別：低危險(xiǎn)級(jí)別：低 Danger Level :Low提問(wèn)技巧提問(wèn)技巧Questioning Techniques5審計(jì)官會(huì)說(shuō)審計(jì)官會(huì)說(shuō)我不明白的問(wèn)題我

14、不明白的問(wèn)題“I dont understand ”Question這是為了確認(rèn)我們的回答與實(shí)際操作的一致性這是為了確認(rèn)我們的回答與實(shí)際操作的一致性Questions the consistency of an explanation舉例舉例Example問(wèn)題問(wèn)題1: 我不確定我是否明白，你能再解釋一下嗎？我不確定我是否明白，你能再解釋一下嗎？Q:I am not sure I understand, could you please explain it again?問(wèn)題問(wèn)題2：我不太明白，能給我舉另外一個(gè)例子嗎？：我不太明白，能給我舉另外一個(gè)例子嗎？Q:I am not clear on

15、this matter, could you show me another example? 危險(xiǎn)級(jí)別：危險(xiǎn)級(jí)別： 中等中等Danger Level: Medium提問(wèn)技巧提問(wèn)技巧Questioning Techniques6. 理論性問(wèn)題理論性問(wèn)題Theory Question假設(shè)某一情形，要求給出可能的結(jié)果。假設(shè)某一情形，要求給出可能的結(jié)果。Expects the person to provide possible outcomes to a situation舉例舉例Example問(wèn)題：如果在處理時(shí)突然斷電，會(huì)發(fā)生什么情況？問(wèn)題：如果在處理時(shí)突然斷電，會(huì)發(fā)生什么情況？Q: What

16、would happen if the power failed during this transaction?-考驗(yàn)應(yīng)答者的知識(shí)面考驗(yàn)應(yīng)答者的知識(shí)面-Tests the knowledge of the interviewee.-體現(xiàn)被審計(jì)方的風(fēng)險(xiǎn)分析形式體現(xiàn)被審計(jì)方的風(fēng)險(xiǎn)分析形式-Represents a form of risk analysis.-確認(rèn)該公司已經(jīng)意識(shí)到可能的風(fēng)險(xiǎn)且有適當(dāng)?shù)姆婪洞胧┐_認(rèn)該公司已經(jīng)意識(shí)到可能的風(fēng)險(xiǎn)且有適當(dāng)?shù)姆婪洞胧?Demonstrates the company is aware of possible risks and has made proper

17、 arrangements.-探測(cè)體系的可靠性。探測(cè)體系的可靠性。Probes the robustness of a system. 危險(xiǎn)級(jí)別：危險(xiǎn)級(jí)別： 中等中等/高高Danger Level: Medium/High提問(wèn)技巧提問(wèn)技巧Questioning Techniques7.無(wú)聲提問(wèn) Silent Question。有時(shí)候應(yīng)答者認(rèn)為審計(jì)官會(huì)對(duì)我們的回復(fù)有些反饋有時(shí)候應(yīng)答者認(rèn)為審計(jì)官會(huì)對(duì)我們的回復(fù)有些反饋-事實(shí)上審計(jì)官事實(shí)上審計(jì)官?zèng)]有繼續(xù)提任何問(wèn)題！沒(méi)有繼續(xù)提任何問(wèn)題！The interviewee is led to believe that some response is exp

18、ected even though no question is actually posed!危險(xiǎn)級(jí)別：危險(xiǎn)級(jí)別： 高高Danger Level: High提問(wèn)技巧提問(wèn)技巧Questioning Techniques8.“我是專(zhuān)家我是專(zhuān)家”型問(wèn)題型問(wèn)題 “Iamtheexpert”Question審計(jì)官總是誘導(dǎo)人員暴露出弱點(diǎn)或缺陷審計(jì)官總是誘導(dǎo)人員暴露出弱點(diǎn)或缺陷- 釣魚(yú)釣魚(yú)。Inspector goes “fishing” where the person is encouraged to show his or her weakness or deficiencies.舉例舉例Examp

19、le問(wèn)題：這是一個(gè)看起來(lái)計(jì)劃的非常好，很詳細(xì)的變更控制體系。但在讓問(wèn)題：這是一個(gè)看起來(lái)計(jì)劃的非常好，很詳細(xì)的變更控制體系。但在讓人員執(zhí)行的過(guò)程中不會(huì)有困難嗎？人員執(zhí)行的過(guò)程中不會(huì)有困難嗎？Q:This looks like a very well planned out and detailed change control system. Dont you have difficulty in getting people to follow this? 危險(xiǎn)級(jí)別：危險(xiǎn)級(jí)別： 非常高非常高Danger Level:VeryHigh提問(wèn)技巧提問(wèn)技巧Questioning Techniques問(wèn)

20、題類(lèi)型問(wèn)題類(lèi)型Question Type典型問(wèn)題典型問(wèn)題Typical Question提問(wèn)目的提問(wèn)目的Purpose of question危險(xiǎn)程度危險(xiǎn)程度Level of danger封閉型Closed你負(fù)責(zé)本部門(mén)的變更控制程序的管理嗎？ “You are responsible for managing the Change Control procedure in this department”檢察官確定提問(wèn)的范圍Defines boundaries for the inspector determines the playing field低 Low開(kāi)放型Open變更控制程序是如何

21、運(yùn)行的？ “How does the Change Control procedure work”打開(kāi)話(huà)題Open up the topic低/中等Low/Medium提問(wèn)型Questioning變更請(qǐng)求時(shí)申請(qǐng)人必須提供哪些信息“What information must the applicant provide in the Change Control request”檢查官對(duì)感興趣的部分進(jìn)一步挖掘Explore particular areas of interest中等Medium提問(wèn)技巧提問(wèn)技巧Questioning Techniques問(wèn)題類(lèi)型問(wèn)題類(lèi)型Question Type典

22、型問(wèn)題典型問(wèn)題Typical Question提問(wèn)目的提問(wèn)目的Purpose of question危險(xiǎn)程度危險(xiǎn)程度Level of danger我不明白型I dont understand關(guān)于這一點(diǎn)，我不是很清楚，能給我看一個(gè)例子嗎？“I am not clear about this, could you show me another example”對(duì)應(yīng)答的真實(shí)性和同實(shí)際的一致性進(jìn)行確認(rèn)。Verification of answers and check on consistency中等Medium 理論型Theory如果變更申請(qǐng)?zhí)峁┑男畔⒉蛔銜?huì)怎么樣？ “What would hap

23、pen if the Change Control request did not contain sufficient information針對(duì)缺陷或弱點(diǎn)提問(wèn)，測(cè)試體系的可靠性Propose weaknesses or deficiencies to test system中等/高M(jìn)edium/High無(wú)聲提問(wèn)型Silent?？纯磿?huì)發(fā)生什么See what happens!高High我是專(zhuān)家型I am the expert對(duì)你來(lái)說(shuō)定期收集到所有信息肯定很困難“It must be difficult for you to get all the information you need o

24、n a regular basis”誘導(dǎo)對(duì)方暴露出已知缺陷Give an opportunity for known deficiencies to emerge非常高Very high提問(wèn)技巧提問(wèn)技巧Questioning Techniques回答問(wèn)題回答問(wèn)題Answering questions仔細(xì)聽(tīng)檢察官的問(wèn)題和評(píng)論Do listen very carefully to the inspectors questions and comments.2. 想清楚了再回答Think before you talk!3. 回答問(wèn)題時(shí)慢慢來(lái)，要從容。準(zhǔn)確地回答問(wèn)題，盡可能真實(shí)。確保第一次回答的答案

25、正確無(wú)誤。不需要趕時(shí)間，但必須回答正確！Take your time to answer the questions. Answer them as accurately and as true as possible. Make every effort to get your answer right the first time. Not fast but correct !4. 讓審計(jì)官先問(wèn)完問(wèn)題！Let the inspector complete the question !5. 讓你的回答聽(tīng)起來(lái)是非?？隙ǖ摹r(shí)刻準(zhǔn)備著使用良好的邏輯和事實(shí)來(lái)答辯。Respond to questi

26、ons in a positive way. Be prepared to defend your company position using good logic and facts. 6. 沒(méi)有提出的問(wèn)題就不要回答。不要自己給自己出題！Do not answer questions not asked. Dont make up your own questions ! 7. 明知答案存在疑問(wèn)，但我會(huì)讓它聽(tīng)起來(lái)是令人信服的這種態(tài)度是完全錯(cuò)誤的！The attitude “In case of doubt, I will make it sound convincing”is totall

27、y wrong!回答問(wèn)題回答問(wèn)題Answering questions8.避免回答是用到以下詞語(yǔ)！Avoid making guesses like:usually we do it.“normally “as far as I know.“I think“通常我們是這么做的。usually we do it.“一般。 normally “據(jù)我所知。as far as I know.我認(rèn)為。 “I think“回答問(wèn)題回答問(wèn)題Answering questions你不應(yīng)該做的事情你不應(yīng)該做的事情What you should NOT do1. 不要對(duì)法規(guī)提出質(zhì)疑不要對(duì)法規(guī)提出質(zhì)疑Dont ch

28、allenge regulations.2. 不要批判官方的方針不要批判官方的方針Dont criticize the agencys policies.3. 不要說(shuō)不要說(shuō)官方官方XXX告訴我們這樣做是可以的，但是你現(xiàn)在跑過(guò)來(lái)告訴告訴我們這樣做是可以的，但是你現(xiàn)在跑過(guò)來(lái)告訴我們要那樣做。我們要那樣做。Dont say “but the agency xyz told us this is okay and now you come and tell us.”4. 不要做過(guò)多的承諾不要做過(guò)多的承諾Do not make over-promises.5. 不要在審計(jì)官面前批評(píng)員工或指責(zé)其他部門(mén)。不

29、要在審計(jì)官面前批評(píng)員工或指責(zé)其他部門(mén)。Never criticize people or blame other departments in front of the inspector!你不應(yīng)該做的事情6. 不要有不耐煩或害怕的表現(xiàn)。 不要說(shuō)“我不負(fù)責(zé)這個(gè)。的， 你為什么想從我這邊了解這個(gè)呢？”。可以這么回答“我現(xiàn)在不能回答這個(gè)問(wèn)題，我需要問(wèn)在這方面知識(shí)豐富的其他專(zhuān)業(yè)人員”。Dont use annoying or scare manners. Do not say, “Im not responsible. why do you want to know this from me ?”.

30、 Rather say “I cannot answer this question right now, we need to ask other experts knowledgeable in this subject area”.7. 保持距離。審計(jì)官坐著，那么就不要站在他面前。Keep the distance. Dont stand in front of a sitting inspector!8. 不要白費(fèi)力氣。一旦某個(gè)缺陷已經(jīng)確定，就不要試圖通過(guò)和審計(jì)官爭(zhēng)論來(lái)挽回局面。You can not ride a dead horse! Whenever an observation

31、 is correct .dont try to save the situation by arguing against it with inspector. 你不應(yīng)該做的事情Unwanted attention一個(gè)人正在開(kāi)車(chē)的人被警察攔下。警察：你在限速55的地方至少開(kāi)了100丈夫：不，先生，我開(kāi)的是60妻子：不，親愛(ài)的，你開(kāi)到75拉警察：我要給你開(kāi)單子，因?yàn)槟銢](méi)系安全帶丈夫：哦，你朝我這走過(guò)來(lái)時(shí)，我剛剛?cè)∠聛?lái)妻子：哦，親愛(ài)的，你老忘記系安全帶丈夫轉(zhuǎn)向他妻子嚷道：安靜點(diǎn)！警察問(wèn)妻子, 你老公總和你這樣說(shuō)話(huà)？妻子：不，只是在他喝醉時(shí)才會(huì)這樣。這個(gè)例子給您什么啟示呢？你不應(yīng)該做的事情1. 不

32、要當(dāng)著審計(jì)官的面，內(nèi)部發(fā)生爭(zhēng)論。2. 不要猜測(cè)，撒謊或給出錯(cuò)誤的信息3. 不要向自己人或向?qū)徲?jì)官發(fā)脾氣。不要提高嗓門(mén)。4. 不要有抵制情緒或受傷的感覺(jué)。5. 如果某個(gè)問(wèn)題不是你專(zhuān)長(zhǎng)的或工作職責(zé)內(nèi)的，需要向?qū)徲?jì)官說(shuō)明。如果你不知道答案，就直說(shuō)。不要害怕說(shuō)“我不知道”。6. 時(shí)刻確保你完全明白問(wèn)題的意思。如果沒(méi)聽(tīng)明白，那么請(qǐng)審計(jì)官再解釋一下。7. 不要一會(huì)兒說(shuō)這個(gè)，一會(huì)兒又說(shuō)其他的（問(wèn)題要一個(gè)個(gè)解決）。檢查官意外的關(guān)注Unwanted attention有一些陳述會(huì)引起審計(jì)官意外的關(guān)注，比如There are some statements which trigger the unwanted a

33、ttention of the inspector:我們是這么做的，但我們沒(méi)有任何記錄We did that but we do not have any documentation“.2. 這個(gè)體系WHO檢查過(guò)的，沒(méi)有發(fā)現(xiàn)缺陷，所以我們認(rèn)為沒(méi)有問(wèn)題That system was inspected by WHO and no observations were made therefore we consider it to be okay.“3. 在會(huì)議上，說(shuō)過(guò)可以這么做，因此我們就這么做了。At conference it is stated that it is okay to do

34、it this way therefore we do it that way“4. 我們不需要做驗(yàn)證，因?yàn)榇蠹叶际褂眠@個(gè)體系/軟件來(lái)做這個(gè)工作的。We do not have to validate because everybody is using this system / software to perform this work“在車(chē)間和實(shí)驗(yàn)室里應(yīng)該做什么Dos for the Shop Floor and Laboratory1. 繼續(xù)工作繼續(xù)工作Continue working. 2. 注意服裝和環(huán)境整潔注意服裝和環(huán)境整潔Mind clothing and clean proc

35、edures. 3. 穿剛清洗過(guò)的衣服穿剛清洗過(guò)的衣服Wear freshly washed clothes4. 門(mén)要關(guān)好門(mén)要關(guān)好Keep doors closed.5. 不要用便簽條不要用便簽條Dont use sticky notes (post-its)6. 當(dāng)不在電腦前時(shí)，關(guān)機(jī)或者關(guān)閉顯示器當(dāng)不在電腦前時(shí)，關(guān)機(jī)或者關(guān)閉顯示器Shut down or “l(fā)ock” monitors when leaving PC/close windows7. 電腦要用密碼保護(hù)電腦要用密碼保護(hù)Protect the PCs with passwords/automatic locking8. 確保你遵守

36、了公司守則確保你遵守了公司守則Make sure you follow a clear company policy.實(shí)驗(yàn)室里需要做什么Dos for the Laboratory1. 及時(shí)記錄Record your work in a timely manner2. 清潔天平，包括天平底下Clean the balance areas, also under the balances!3. 使用檢測(cè)規(guī)程，不只是拿著記錄本做實(shí)驗(yàn)Use the testing instructions, not just the record templates4. 當(dāng)被要求解釋或討論某儀器的確認(rèn)文件時(shí)，讓專(zhuān)業(yè)

37、人員來(lái)回答。When asked to explain or discuss any instrument qualification documentation, ask for the expert實(shí)驗(yàn)室里需要做什么Dos for the Laboratory5. 專(zhuān)業(yè)人員或儀器負(fù)責(zé)人應(yīng)該十分熟悉儀器確認(rèn)程序和過(guò)程（事先仔細(xì)閱讀）The expert/instrument responsible should be familiar with the qualification binders and process - read it before6. 不要做一些危險(xiǎn)實(shí)驗(yàn)，或氣味難聞的實(shí)

38、驗(yàn)。Do not work on any dangerous or experiments that may not smell good7. 檢查所有檢測(cè)規(guī)程，把上面的提示訣竅，便簽紙，鉛筆印等等通通去掉。Go through your testing instructions and remove the tips and tricks and post-its or pencil writing8. 當(dāng)審計(jì)官只查看某個(gè)文件時(shí)，不要抱過(guò)來(lái)整個(gè)文件夾（里面還放著其他文件）。Do not bring a big folder with other documents when only 1 d

39、ocument was asked by inspector實(shí)驗(yàn)室里需要做什么Dos for the Laboratory9. 在審計(jì)過(guò)程中始終戴著安全防護(hù)鏡Always wear the safety glasses during the inspection10. 抽屜上標(biāo)識(shí)“私人用品”，會(huì)相對(duì)安全一點(diǎn)Drawers that are marked private“ are relatively safe11. 不要使用“私人”或未受控的SOPDo not use private“ or uncontrolled copies of SOPs12. 不要驚慌或跑來(lái)跑去，安全地走動(dòng)。Do n

40、ot panic or run around, use safe transportation practice審計(jì)管理團(tuán)隊(duì)要做些什么Dos for the Inspection Mgmt Team1. 確保所有出席的人員都能承受壓力。在檢察官來(lái)之前，所有關(guān)鍵人員都已在會(huì)議室等候。Make sure that people who do present can cope with the stress. Let the key presenters present before the agency comes in. 2.保護(hù)我們的人員！如果回答問(wèn)題的人太緊張了，那么找個(gè)借口幫他/她撤離出來(lái)

41、。Protect your people! If an interviewee is too nervous, excuse him/her and get him/her out of the situation.3. 控制形勢(shì)。如果出現(xiàn)劍拔弩張的情形，可以建議休息一下，降降溫。Control the situation. If tension is building up and somebody starts to become aggressive call for a break and try to cool him/her down.4. 表?yè)P(yáng)我們的人員！一個(gè)良好的團(tuán)隊(duì)精神大大有

42、助于順利通過(guò)檢查。Praise your people ! A good team spirit helps greatly to get through the inspection. 每個(gè)人要做的事情Dos for everybody大家花很多時(shí)間來(lái)討論問(wèn)題和弱點(diǎn)，卻忘了有很多做得好的地方！People spend so much time discussing problems and weaknesses that they forget how many things they do well!把自己工作好的方面呈現(xiàn)給審計(jì)官DO PRESENT THE GOOD ASPECTS OF

43、 YOUR WORK TO THE INSPECTOR.你在公司里是專(zhuān)業(yè)人員! YOU ARE THE EXPERT IN YOUR COMPANY. 這是你的地盤(pán)！利用這個(gè)優(yōu)勢(shì)！THIS IS YOUR SITER! TAKE THE ADVANTAGE! API車(chē)間里每個(gè)人要做些什么Dos for everybody in all API plants由API QA專(zhuān)業(yè)人員進(jìn)行高水平的GMP內(nèi)審Internal goodlevelGMP auditsfromQA API Experts每天由車(chē)間QA和工程人員檢查Daily walk down QA Experts with Plant M

44、anagers and with Production Director2. 數(shù)據(jù)完整性和批記錄檢查，不要出現(xiàn)小本子之類(lèi)的無(wú)關(guān)東西Data Integrity, Batch records and no small booklets3. 確保所有車(chē)間和共用房間是干凈整潔有序的。All plants, utilities roomsarecleaned, andwell organized4. 所有的設(shè)備，管道，閥門(mén)，房間都要標(biāo)識(shí)好All equipments, pipes, valves,roomsarewell labelled5. 沒(méi)有敞開(kāi)的屋頂，窗戶(hù)，門(mén)。No open roof, noopen windows, doors,6. 沒(méi)有滲漏No uncontrolled air inside API plants，No leakages API車(chē)間里每個(gè)人要做些什么Dos for everybody in all API plantsPLANTS, FACILITIES7. 確保確認(rèn)文件齊備all qua