制藥企業(yè)實(shí)驗(yàn)室FDA檢查列表

1、MANAGERIAL SYSTEM管理系統(tǒng)Admi nistrative/Role & Resp on sibilities管理的作用和職責(zé)YESNOCurre nt orga ni zati on charts available and accurate?當(dāng)前可用的、正確的組織構(gòu)造圖Policy/procedure that defines the responsibility and authority of QC unit. 規(guī)定QC部門的權(quán)力和職責(zé)的方針或程序Have the responsibilities of each functional group and supe

2、rvisor been clearly Defined, including testing and operational requirements, SOPs, and all other Critical functions?每一個(gè)分工小組和管理者的職責(zé)應(yīng)有明確的規(guī)定，包括測試和操作要求、SOPS以及其他的關(guān)鍵要求。Is an organizational structure in place and properly staffed to assure all required Testing/monitoring suppo activities are performed?是否有適

3、當(dāng)?shù)慕M織構(gòu)造，使員工保證所有要求檢驗(yàn)、監(jiān)測支持活動(dòng)必須被執(zhí)行。tIs the spa n of con trol adequate? 控制范圍是否適當(dāng)、充分？What is the ratio of supervisi on to an alyst? 分析員監(jiān)視比率是多少？Are the roles and responsibilities for each position clearly defined? 每一個(gè)崗位或職位的作用與職責(zé)是否被明確的規(guī)定？Are job descripti ons available? 是否有職位說明？Are sig nature authority, res

4、p on sibility, and acco un tabilities appropriate and clearly defi ned? 簽名權(quán)力、責(zé)任、適當(dāng)?shù)?問責(zé)制是否有明確地規(guī)疋？Do systems exist to enhance com muni cati on, un dersta nding, and working relati on ships betwee n Laborato and QA pers onn el?在實(shí)驗(yàn)室與QA之間是否有加強(qiáng)信息溝通、理解以及工作關(guān)系的程序？yDoes a pers onnel performa nee evaluati on s

5、ystem exist which tracks Laboratory Pers onnel stre ngths and weak ness and establishes corrective action procedures to Mitigate any weak ness是否有人員業(yè)績?cè)u(píng)估程序，跟蹤實(shí)驗(yàn)室人員的優(yōu)勢(shì)和劣勢(shì)，建立矯正行動(dòng)程序，減輕任何弱點(diǎn)？Does a master testi ng schedule or similar docume nt(s) exit to in sure smooth workflow, and mi ni mize Laboratory p

6、ers onnel over commitme nt?是否有用以保證順利工作流程，最小化實(shí)驗(yàn)室人員上面的的承諾的主要試驗(yàn)大綱或類似的文件(s)？Do curre nt CV's and resumes exist for all pers onnel in clud ing con sulta nts? 是否有所有員工包括參謀的個(gè)人簡歷？Trai ning培訓(xùn)Have the educati on al, training and work experie nee requireme nts for each laboratory positi on bee n clearly def

7、i ned and do they reflect curre nt sta ndards in the in dustry?對(duì)于每一個(gè)實(shí)驗(yàn)室崗位的教育、培訓(xùn)和工作經(jīng)歷強(qiáng)化培訓(xùn)方案需求是否有明確的規(guī)定？對(duì)于行業(yè)中的現(xiàn)行標(biāo)準(zhǔn)，他們是否可以反映？Are training requireme nts clearly docume nted in a SOP. (In cludi ng Man agers, Supervisors, An alysts and Temporary staff)?培訓(xùn)需求在SOP中是否有明確的規(guī)定包括經(jīng)理、管理者、分析員以及臨時(shí)員工？Has a training cur

8、riculum been developed for each position which clearly identifies all required SOPs and Policies, safety, cGMPs as well as all other in ternal and exter nal courses or programs? (Database or har copy?)每個(gè)位置需要的SOPS策略、平安、cGMPs以及所有其他的內(nèi)部和外部的課程或者方案(數(shù)據(jù)庫 或硬拷貝)的培訓(xùn)課程是否被開發(fā)？dIs job-specific training ide ntified

9、? 僅限于工作的培訓(xùn)鑒定了嗎？Does each employee have a training file? 每位員工是否都有培訓(xùn)文件資料？Are the trai ning histories for each in dividual curre nt? (Database or hard copy?) 當(dāng)前的每位員工是否都有培訓(xùn)歷史？數(shù)據(jù)庫或硬拷貝？Have all laboratory pers onnel bee n properly train ed? 所有試驗(yàn)人員是否得到適當(dāng)?shù)呐嘤?xùn)？Is this training docume nted and where do these d

10、ocume nts reside? 是否有培訓(xùn)記錄，并存檔？How is SOP trai ning con ducted? 如何實(shí)施SOP培訓(xùn)？Are metrics used to determ ine acceptability? 是否有可承受的標(biāo)準(zhǔn)？Is there a laboratory certificati on program? 是否有實(shí)驗(yàn)室認(rèn)證程序？Has an in dividual bee n desig nated as the training coordi nator or man ager? 是否有固定的培訓(xùn)協(xié)調(diào)員或經(jīng)理？Is there evide nee o

11、r rma nageme nt support for trai ning and trai ning programs? 是否有培訓(xùn)和管理培訓(xùn)方案的程序文件？Does a formal trai ning budget exist? 是否有一個(gè)正式的培訓(xùn)經(jīng)費(fèi)預(yù)算？Do ven dor-trai ning records exist? 是否有供給商培訓(xùn)記錄？Is there evide nee that n ewly hired employees are evaluated for skill level and compete ncy 是否有證據(jù)說明新聘用的員工是經(jīng)過技術(shù)水平和能力的評(píng)估？

12、Is there a formal training schedule in place and is being executed? 是否有一個(gè)正式的培訓(xùn)方案并正在執(zhí)行？Is there evide nee of employee re-tra ining? 是否有員工再培訓(xùn)的證據(jù)？Is there a positive attitude with respect to trai ning on the part of Man ageme nt and Laboratory pers onn el? 關(guān)于對(duì)實(shí)驗(yàn)室的管理和人員培訓(xùn)這局部是否有一個(gè)積極的態(tài)度？Change Con trol 變更

13、控制Is there a curre nt Change Con trol system and writte n procedure for authorizatio n, docume ntati on and impleme ntatio n of cha nges that may have a regulatory or quality impact?是否有經(jīng)批準(zhǔn)的日常變更控制系統(tǒng)和訴訟的書面程序？是否有變更執(zhí)行后的監(jiān)管或?qū)|(zhì)量的可能影響？Who is resp on sible for adm ini strati on and approval of Change Con tro

14、l system? 誰負(fù)責(zé)管理變更控制系統(tǒng)？誰負(fù)責(zé)審批變更控制系統(tǒng)？Is there a track ing system for cha nges? 是否有變更跟蹤系統(tǒng)？Does the Change Con trol system in clude mecha ni sms for pla nned cha nges to: 變更控制系統(tǒng)是否包括對(duì)方案的變更機(jī)制：Sta ndard Operat ing Procedures? 標(biāo)準(zhǔn)操作規(guī)程SOP？Formulati on? 處方？Manu facturi ng Process生產(chǎn)過程？Major Equipme nt? 主要設(shè)備Batch

15、 Size? 批量？Production Site?生產(chǎn)地點(diǎn)？Raw Material or Packag ing Material Supplier/Process? 原輔料和包裝材料的供給商及生產(chǎn)過程？Testi ng Methods? 測試方法？Product Specificati ons? 產(chǎn)品規(guī)格？Raw and Packag ing Material Specificati on? 原輔料和包裝材料明細(xì)表？Chan ges in Regulatory Requireme nts? 變化的監(jiān)管要求？Defining Major and Minor Chan ges? 定義主要和次要

16、的變化？How are un pla nned cha nges made? 無方案的變更是如何發(fā)生的？Who approves those cha nges? 誰批準(zhǔn)這些變更？Com mun icatio ns/Reports通信/報(bào)告Does the lab con duct statistical quality con trol? 實(shí)驗(yàn)室是否進(jìn)展統(tǒng)計(jì)質(zhì)量控制？How is this in formatio n com muni cated? 此信息是如何傳達(dá)的？Are lab OOS results tren ded?實(shí)驗(yàn)室OOS結(jié)果的趨勢(shì)如何？Is there a system to

17、 inform QA of n egative tren ds? 這個(gè)系統(tǒng)在通知QA的過程中是否有消極的趨勢(shì)？Is management notified in a timely manner of all laboratory rejections and negative trends? 在拒絕了所有實(shí)驗(yàn)室和消極的趨勢(shì)后，是否及時(shí)的通知了管理人員？Is the information on OOS,lot rejections,etc.supplied in a timely fashion for Annual Product Reviews? 在年度產(chǎn)品回憶中，是否有 OOS的信息，包

18、括供給商？Are laboratory operati ons audited routi nely? 是否有實(shí)驗(yàn)室操作常規(guī)審計(jì)？What is the freque ncy? 頻率是什么？Are the results docume nted? 結(jié)果是否記錄？Are corrective acti ons done in a timely manner? 是否及時(shí)糾正？Who receives copies of the audit reports, resp on ses? 審計(jì)報(bào)告的副本給誰？是否有反響？Is there a self-audit program in place?是否有

19、一個(gè)適當(dāng)?shù)淖詫彸绦?？Docume nted?記錄？Follow-up on Corrective Actions? 對(duì)糾正措施的落實(shí)？Are in ternal audit reports reviews with an alyst? 是否有內(nèi)審報(bào)告回憶與分析？Are there systems for periodic review of test ing programs and QA systems to rema in curre nt with in dustry sta ndards?這個(gè)系統(tǒng)是否有定期審查的測試程序，QA系統(tǒng)是否是現(xiàn)行的行業(yè)標(biāo)準(zhǔn)？Has this process

20、been mapped, does it identify timelines, corresponding SOP and is the map visible to others?這個(gè)過程是否被映射，有確定的時(shí)間表，對(duì)應(yīng)的SOP以及被其他人看見？What laboratory committees are in place? 實(shí)驗(yàn)室委員會(huì)全體委員是否到位？How are the laboratory committee(s) meet ing mi nu tes and acti ons proposed and take n com muni cated with the departm

21、e nt?實(shí)驗(yàn)室委員會(huì)如何實(shí)施會(huì)議紀(jì)要，并在提出和采取行動(dòng)的部門內(nèi)部實(shí)施溝通？inAre data reported in all types of reports easily traceable to raw data? 報(bào)告中的數(shù)據(jù)是否容易追蹤到所有類型的原始數(shù)據(jù)？Tre ndin g-Statistical Quality Con trol 趨勢(shì)統(tǒng)計(jì)質(zhì)量控制Is con trol chart ing of data performed? 數(shù)據(jù)控制圖表是否被執(zhí)行？Points to con sider:考慮的要點(diǎn)Fini shed product 成品Raw material 原輔料Co

22、vered by an SOP 覆蓋的SOPFreque ncy of evaluati on of con trol chart 頻率控制圖的評(píng)價(jià)Appropriate ness of resp onse to evaluatio ns 適當(dāng)?shù)幕貞?yīng)評(píng)價(jià)Stability Data 穩(wěn)定的數(shù)據(jù)Complai nts投訴Is there a formal product compla int han dli ng system in place, in clud ing some system of compla int monitoring, and statistical review?是否

23、有適當(dāng)?shù)漠a(chǎn)品投訴系統(tǒng)，包括一些投訴監(jiān)控系統(tǒng)，以及統(tǒng)計(jì)回憶？Points to con sider: 考慮的要點(diǎn)：Defined by SOPSOP的定義Con siste nt with regulatory and in dustry practice 符合法規(guī)和行業(yè)慣例Laboratory Purchas ing 實(shí)驗(yàn)室采購Are levels of approval defi ned and appropriate 是否規(guī)定適當(dāng)?shù)募?jí)別？Are items purchased from qualified ven dors (e.g. raw materials, rege nts, st

24、a ndards, in strume nts, etc.)? 是否有資質(zhì)的供給商目錄原材料、試劑、標(biāo)準(zhǔn)品、儀器等等？OPERATING PROCEDURES操作規(guī)程SOPs-Ge neralSOPs-通那么Is there a comprehe nsive and curre nt laboratory Sta ndard Operati ng Procedure system? 是否有一個(gè)綜合的和目前實(shí)驗(yàn)室的標(biāo)準(zhǔn)操作規(guī)程程序？Is there a list of all approved SOPs? 是否有所有批準(zhǔn)的SOP目錄？Are the SOPs curre nt, clearly

25、writte n and accessible to all appropriate pers onn el? 現(xiàn)行的SOPs,對(duì)與所有相關(guān)人員是否都是書面明確的和可理解的？Is there a system for periodic review of all SOPs to assure that they are consistent with current Company and in dustry practices?是否有所有SOP的定期審核制度，以確保它們與當(dāng)前公司和行業(yè)慣例一致？Is there an SOP gover ning the SOP program? 是否有一個(gè)

26、SOP管理程序來管理SOP？Is there a system for con troll ing the issua nce and revisio n of all SOPs? 是否有控制發(fā)放和修訂所有SOP的系統(tǒng)？Are policies and manu als used that suppleme nt the un its SOPs? 是否有政策和手冊(cè)中使用的SOPs的單位補(bǔ)充？How easily accessible are they? 他們?nèi)绾稳菀椎某惺?？Are all SOPs reviewed and updated at least every 3 years? 所有的

27、SOP回憶和更新至少每3年1次Are There Specific Stan dard Operat ing Procedures Coveri ng: 是否有具體的SOP覆蓋？Cha nge Con trol? 變更控制Record review and release requireme nts? 記錄審核與放行的要求？Descriptio n of the requireme nts for perform ing data review? 數(shù)據(jù)審核要求的描述？Laboratory records (are raw data recorded in bound no tebooks or

28、 con trolled worksheets?) 實(shí)驗(yàn)室記錄受控的原輔料數(shù)據(jù)記錄本或者工作表Dissoluti on testi ng? 溶解測試？Sample receipt, docume ntati on, han dli ng, storage, and con trol? 樣品承受、登記、處理、存儲(chǔ)和控制？Laboratory inv estigatio n/OOS results? 實(shí)驗(yàn)室調(diào)查/OOS結(jié)果？Validati on of An alytical methods? 分析方法驗(yàn)證？Impurity policy for new impurities an d/or hi

29、gher levels of previously knows impurities? 新的雜質(zhì)，和/或高含量的雜質(zhì)的驗(yàn)證？Laboratory computer validati on? 實(shí)驗(yàn)室計(jì)算機(jī)驗(yàn)證？Preparation, labeling, identification, expiration-dating, and storage of chemicals, Reagents and solutions? 制備、標(biāo)簽、標(biāo)識(shí)、產(chǎn)品有效期和化學(xué)品儲(chǔ)存，試劑和溶液？Equipme nt/ln strume nt use, PM, calibratio n and qualificati

30、 on? 設(shè)備/儀器的使用，管理、校準(zhǔn)和確認(rèn)Appropriate labeli ng of out of use lab equipme nt? 不再被使用的實(shí)驗(yàn)室設(shè)備的標(biāo)志？Glassware wash ing? 玻璃器皿清洗？Lockers for an alysts, uni forms?分析員是否有衣帽柜，是否有工作服？Practices regard ing housekeep ing, safety glasses, eat ing in labs, smok ing, etc.? 實(shí)驗(yàn)室日常操作中關(guān)于家務(wù)活、平安眼鏡、吃飯、抽煙等是否存在？Waste disposal?廢物處理

31、？Laboratory Sample?實(shí)驗(yàn)室樣品處理？Is there an SOP for defining appropriate sampling plans for all QA testing? 是否有規(guī)疋所有QA測試的適當(dāng)?shù)娜臃桨?？Are samples ran domly chose n and are they represe ntative of all porti ons of the lot? 抽樣是否是隨機(jī)選擇的樣本，是否具有帶表性？Is there an SOP for receipt, documentation, handling, storage and di

32、stributen of laboratory samples? 實(shí)驗(yàn)室是否有樣品承受、登記、處理、存儲(chǔ)和分發(fā)的SOP?Is a sample log-book maintain ed? 是否有連續(xù)的樣品登記簿？Are samples tracked? 樣品是否有跟蹤？Is sample dispositi on in cluded in track ing? 樣品是否有處理，包括跟蹤？Are areas available for sample dispositi on( rete nti on, destructio n) 是否有樣品處理的地方保存、銷毀？Is there an autho

33、rized sig nature list, in cludi ng pers ons n ames, in itials, and resp on sibilities? 是否有批準(zhǔn)的清單，包括姓名英文名的人名、字母、責(zé)任？Are records available and are samples labeled appropriately to in clude: Sample descripti on, source, qua ntity, date sampled, date sample received for test ing?記錄是否適用，樣品應(yīng)該貼簽，包括：樣品種類、來源、數(shù)

34、量、取樣時(shí)間、測試收到樣品的時(shí)間？Are sample storage areas properly ide ntified and maintain ed? 是否能正確識(shí)別樣品的保存和維護(hù)區(qū)域？Is there a sample backlog? 是否有樣品積壓？Laboratory Chemicals, Soluti ons and Reage nts: 實(shí)驗(yàn)室化學(xué)品、溶液和試劑Is there a writte n procedure for receipt/storage of chemicals and reage nts? 化學(xué)品和試劑的承受和存儲(chǔ)是否有書面的規(guī)程？Are they

35、 properly labeled with date of receipt, date ope ned and expirati on and retest dates? 瓶子上是否有承受日期、開瓶日期、有效期或者失效期和復(fù)驗(yàn)期等？Are lab prepared reage nts and soluti ons properly ide ntified? (chemical n ame or symbol, concen trati on, dat of preparati on, in itials of the an alysts who prepared it, expirati o

36、n date)實(shí)驗(yàn)室配制的試劑和試液是否有適當(dāng)?shù)臉?biāo)識(shí)？化學(xué)名稱或符號(hào)、濃度、配置日期、配置人、有效 期eAre records available to docume nt preparatio n and sta ndardizati on of volumetric soluti ons? 試劑和試液是否有配制記錄，滴定液是否有標(biāo)化記錄？Is the freque ncy of sta ndardizati on of various reage nts described? 各種試劑的標(biāo)化頻率是否規(guī)定？Is it consistent with USP?是否符合美國藥典？Are sta

37、ndardized reage nts stored to assure in tegrity? 標(biāo)準(zhǔn)化試劑的存儲(chǔ)，以保證完整性？Are procedures for preparati on of laboratory reage nts and cultures described? 實(shí)驗(yàn)室試劑和培養(yǎng)基的配制過程是否有規(guī)定？Are procedures for maintenan ces of laboratory reage nts/cultures described? 實(shí)驗(yàn)室試劑和培養(yǎng)基 維護(hù)是否有規(guī)定？Laboratory Refere nee Stan dards: 頭驗(yàn)至參考標(biāo)

38、準(zhǔn)Is there a writte n procedure for orderi ng and receipt of compe ndial sta ndards and non-compe ndial refere n( sta ndards?是否有訂購和承受藥典標(biāo)準(zhǔn)和非藥典參考標(biāo)準(zhǔn)的書面規(guī)程？:eAre the primary standards the current lot listed in the USP? 一級(jí)標(biāo)準(zhǔn)是否是美國藥典中列出的？Is their receipt logged?承受是否有記錄？Are all sta ndards labeled with n ame,

39、source, lot nu mber and expirati on date? 所有的標(biāo)準(zhǔn)標(biāo)識(shí)是否包括：名稱、來源、批號(hào)和有效期？Do writte n procedures in clude provisi ons for preve nti on of con tam in ati on of Primary sta ndards? 對(duì)污染預(yù)防的根本標(biāo)準(zhǔn)是否有書面的規(guī)程？Are sta ndards stored in a secured area un der en viro nmen tally Con trolled and moni tored con diti ons? 標(biāo)準(zhǔn)

40、是否在有環(huán)境控制和監(jiān)測條件的環(huán)境中儲(chǔ)存？Are procedures for assuri ng sta ndard in tegrity available? 是否有規(guī)程保證標(biāo)準(zhǔn)完整可用？Are work ing or "house" sta ndards checked aga inst primary sta ndards at least every Two years? 工作標(biāo)準(zhǔn)或企業(yè)標(biāo)準(zhǔn)是否至少每 2年跟一級(jí)標(biāo)準(zhǔn)核對(duì)一次？Are stock soluti ons appropriately ide ntified, and are their re-use ba

41、sed on their stability? 儲(chǔ)臧溶液是否有適當(dāng)?shù)囊?guī)疋，重新使用是否建立在它們的穩(wěn)疋性根底上的？Do procedures exist for the certificati on and use of non-commercially available Refere nee sta ndards? 是否有認(rèn)證的程序和非商業(yè)化運(yùn)作方面存在的參考標(biāo)準(zhǔn)？Do certificates of an alysis exist for all refere nee sta ndards and are these certificates stored as con trolled

42、docume nts?所有參考標(biāo)準(zhǔn)是否有COA，并作為受控文件存儲(chǔ)？Have provisi ons bee n made for han dli ng con trolled substa nee refere nee sta ndards? 是否規(guī)定了處理受控物質(zhì)的參考標(biāo)準(zhǔn)？Does the refere nee Stan dard SOP address proper han dli ng of con trolled substa nee Refere nee sta ndards? 參考標(biāo)準(zhǔn)SOP解決受控物質(zhì)的參考標(biāo)準(zhǔn)，是否妥善處理？Laboratory Test Procedure

43、s 實(shí)驗(yàn)室測試過程Is there an index listing the testing documents/specifications? 是否有索引列表的測試文件/明細(xì)單？How is this list updated and con trolled? 列表如何更新和控制？Do the test procedures in elude sufficie nt in structi ons to con duct the testi ng and operate the specific lab in strume nts?測試過程包括足夠的管理測試的操作指南和操作具體的試驗(yàn)儀器？Is

44、 there a system for con troll ing the issua nee and revisio n of all test ing related records? 是否有一個(gè)系統(tǒng)控制發(fā)放和修訂所有的與測試相關(guān)的記錄？Are laboratory test procedures and specificati ons approved by the QA un it? 實(shí)驗(yàn)室的測試程序和說明是否是經(jīng)QA部門批準(zhǔn)的？Is there a writte n Change Control procedure coveri ng maki ng methods cha nges

45、? 是否有書面的變更控制程序，包括改良方法的變更？Are specificatio ns for compe ndial products meeti ng compe ndial requireme nts? 是否有滿足藥典要求的產(chǎn)品說明？How are "in-house" or tighter release specificatio ns determ in ed? 內(nèi)控或更嚴(yán)格的版本的規(guī)定是如何確定的？Covered by SOP?SOP的覆蓋？Are raw materials released by using validated an alytical me

46、thods? 原輔料的放行，使用的是否是經(jīng)歷證過的分析方法檢測的？What methods are used to release raw materials? 用什么方法來放行原輔料What methods are used to release contain er/closures? 用什么方法來放行容器/貼封？包裝材料Laboratory Data and Results 實(shí)驗(yàn)室數(shù)據(jù)和結(jié)果Is data docume nted in bound pre-nu mbered logbook, no tebook, or other data acquisiti on system? 有在

47、預(yù)先編號(hào)的日志，筆記簿，或者其他數(shù)據(jù)采集系統(tǒng)記錄的數(shù)據(jù)？Is the use of scrap paper, "post its", or similar uncon trollable paper specifically prohibited in the laboratory? 實(shí)驗(yàn)室明確制止使用便條紙、貼紙、或者類似不受控的紙張Are corrective to data entry errors covered in an SOP? 是否有SOP規(guī)定數(shù)據(jù)輸入錯(cuò)誤的糾正？Are all docume nts/data writte n in perma nent i

48、nk? 記錄和數(shù)據(jù)是否是用永久墨水書寫的？If bound no tebooks are used, is there a system for con trol, issua nee and use? 如果使用筆記簿，是否有控制、簽發(fā)和使用的程序？Is each page dated and sig ned by the an alyst and sec ond review ing authorized in dividual in a timely manner?每一頁是否有分析員簽名、并簽署日期？及時(shí)由經(jīng)批準(zhǔn)的第二人復(fù)核？Are all en tries checked and app

49、roved for complete ness of sample ide ntity, reage nts, sta ndards, experimen con diti ons and purpose?所有工程檢查和核準(zhǔn)，包括樣品身份、標(biāo)準(zhǔn)、試驗(yàn)條件和目的？talAre chromatograms, spectra, etc. appropriately ide ntified, stored, refere need to no tebooks and readily retrievable色譜、光譜等是否有適當(dāng)?shù)淖R(shí)別標(biāo)志、存儲(chǔ)、參考的筆記簿和容易獲得的？Are the date, ca

50、lculati ons and results verified by sec ond compete nt in dividual for accuracy, complete ness and compliance with specifications?數(shù)據(jù)、計(jì)算和第二人結(jié)果復(fù)核，要求準(zhǔn)確的、完整的和符合標(biāo)準(zhǔn)要求Are the qualificati ons of pers on con duct ing the review acceptable? 對(duì)人的資格審查，是否可以承受？Is the review docume nted by full sig nature and date?

51、 檢查是否用全簽名和日期？Are levels of approval described? 是否有批準(zhǔn)的水平描述？Are data review and approval activities captured in LIMS?在LIMS實(shí)驗(yàn)室信息管理系統(tǒng)系統(tǒng)獲得的數(shù)據(jù)，是否經(jīng)審查和批準(zhǔn)？Are results approved before distributi on? 在放行前，結(jié)果是否經(jīng)過批準(zhǔn)？If so, by whom?如果是這樣，那是誰？How do you assure that the method being used in the laboratory is the cu

52、rre nt approved vers ion method fc testi ng this product?如何保證實(shí)驗(yàn)室采用的方法是目前經(jīng)批準(zhǔn)的版本，用于測試該產(chǎn)品的的方法？，rDo you record the method used on to the laboratory test ing results sheet? 實(shí)驗(yàn)室檢測結(jié)果中使用的方法是否記錄？Is the laboratory method recorded into LIMS?實(shí)驗(yàn)室方法是否是用LIMS實(shí)驗(yàn)室信息管理系統(tǒng)？Is there a written SOP for handling of reintegr

53、ation of HPLC/GC data? 是否有HPLC/GC數(shù)據(jù)處理的書面的SOP？If a computer software package is used to calculate results, is there an example calculatio n in cluded with t reported results verify ing proper algorithm executi on?如果用計(jì)算機(jī)軟件來計(jì)算的結(jié)果，與一個(gè)實(shí)例計(jì)算與文獻(xiàn)報(bào)道的結(jié)果驗(yàn)證算法，是否在一個(gè)適當(dāng)?shù)姆秶鷥?nèi)？heAre all correcti on factors used in cal

54、culati ons expressed with proper un its? 在適當(dāng)?shù)膯挝挥?jì)算中，所用數(shù)據(jù)的修約？Are raw data defi ned in an SOP?SOP中是否有原始數(shù)據(jù)的定義？Security of Data 數(shù)據(jù)保密Is access stored data limited?存儲(chǔ)數(shù)據(jù)的訪問是被限制的？Are data protected from fire, water, and other en vir onmen tal hazards? 火災(zāi)、水災(zāi)和其他的環(huán)境危害中數(shù)據(jù)的保護(hù)？Is readily retrievable? 可隨時(shí)檢閱？How is

55、it con trolled?如何控制？How long are data kept and how is docume ntati on rete ntio n times determ in ed? 數(shù)據(jù)可保存多久，記錄保存時(shí)間是如何確定的？Are backup copies of data stored at an off-site locati on? 備份數(shù)據(jù)是在原位置以外的地方？Is there a disaster recovery pla n, and has it bee n rehearsed? 是否有一個(gè)災(zāi)難恢復(fù)方案，并且它已經(jīng)被演練？Distribution of Results 結(jié)果放行Are results en tered in to a LIMS or other electro nic man ageme nt sy