1、FDA Warning Letters, Form 483 Observations, Establishment Inspection ReportsFDA警告信，483缺陷表，檢查報(bào)告Important: Warning letters should be interpreted in the context of full content. Just looking at extracts may be misleading. And sometimes they include good advice from the FDA not mentioned in the extracts

2、.重要的警告信可能會(huì)用完整的上下文內(nèi)容來解釋。只看摘要可能會(huì)導(dǎo)致誤解。有時(shí)候完整的內(nèi)容會(huì)包含摘要中沒有包括的來自FDA的建議。W-194Keywords: GLP, raw data, reason for change, responsibilities of QAU, integrity of study data關(guān)鍵詞：GLP, 原始數(shù)據(jù)，變更理由，質(zhì)保責(zé)任，研究數(shù)據(jù)的完整性 Primary Deviations: Incomplete study records, no reason for change of study records, QAU not fulfilled its

3、responsibilities, raw data, no assurance of the quality and integrity of study report, no final study report, no or inadequate testing and calibration of equipment 主要錯(cuò)誤：研究數(shù)據(jù)不完全，沒有理由地改變研究記錄，質(zhì)保未履行職責(zé)，原始數(shù)據(jù)，研究報(bào)告的質(zhì)量和完整性沒有保證，沒有最終研究報(bào)告，檢測(cè)和儀器檢驗(yàn)沒有或不夠。 Examples: - Failure of the study director to assure that al

4、l experimental data were accurately recorded and verified and document the reason for any change in the entries- For study xxx your study director failed to assure that dosing were accurately recorded to confirm that study animals received protocol-specified doses of the vehicle.- Failure of QAU to

5、assure that reported results in the final study report accurately reflected the raw data- Failure of QAU to maintain written and properly signed records of each periodic inspection- Failure to identify the test and control articles with appropriate characteristics in the final report- Failure to ade

6、quately test, calibrate, and/or standardize all equipment used the generation, measurement and assessment of data 事例：研究主管未能保證所有的實(shí)驗(yàn)數(shù)據(jù)被準(zhǔn)確記錄，也未能確認(rèn)任何條目的變更理由并記錄。為研究xxx，你們的研究主管未能保證準(zhǔn)確記錄劑量以確保試驗(yàn)動(dòng)物接受研究草案中規(guī)定的劑量質(zhì)保未能保證最終研究報(bào)告中的結(jié)果準(zhǔn)確反映原始數(shù)據(jù)質(zhì)保未能在階段性的檢查中持續(xù)填寫記錄并適當(dāng)簽名在最終研究報(bào)告中沒有用合適的特定的格式來鑒別測(cè)試和控制內(nèi)容沒有對(duì)產(chǎn)生，測(cè)量及評(píng)估數(shù)據(jù)的設(shè)備進(jìn)行足夠的測(cè)試，校

7、準(zhǔn)和/或標(biāo)準(zhǔn)化W-193Keywords: Batch records, method validation, cleaning validation, equipment calibration 關(guān)鍵詞：批記錄，方法驗(yàn)證，清潔驗(yàn)證，設(shè)備校準(zhǔn) Primary Deviations: Incomplete batch records, insufficient documentation of method validation, inadequate documentation of laboratory equipment calibration, shipment of APIs to U

8、S from non certified manufacturing site 主要錯(cuò)誤：批記錄不完整，方法驗(yàn)證文件不夠，實(shí)驗(yàn)室設(shè)備校準(zhǔn)文件不充分，從未經(jīng)確認(rèn)的生產(chǎn)地點(diǎn)向美國(guó)出貨 Examples: - Batch production records do not include complete information relating to the production and control of each API batch- Method validation documentation did not include appropriate data to verify that

9、 the analytical method produced accurate and reliable data- Production equipment was not adequately cleaned and was not maintained in a good state of repair - Laboratory equipment calibration was not adequately documented. 事例：批生產(chǎn)記錄沒有包括與每個(gè)批次的生產(chǎn)與控制相關(guān)的完整信息方法驗(yàn)證文件沒有包含適當(dāng)?shù)臄?shù)據(jù)以確認(rèn)分析方法能產(chǎn)生準(zhǔn)確和可靠數(shù)據(jù)生產(chǎn)設(shè)備清潔不夠，且在修理狀態(tài)

10、下沒有維修實(shí)驗(yàn)室設(shè)備校準(zhǔn)沒有被完全記錄 W-192Keywords: Data security, raw data, passwords, laboratory software關(guān)鍵詞：數(shù)據(jù)安全性，原始數(shù)據(jù)，密碼，實(shí)驗(yàn)室軟件  Primary deviations: no individual passwords, ability to overwrite raw data.   主要錯(cuò)誤：沒有個(gè)人密碼，可以改寫原始數(shù)據(jù)  Examples: - Validation of the (brand name) laboratory s

11、oftware used to control instruments, generate data, perform calculations, and store data from raw material and finished product testing failed to demonstrate adequate security. Analysts have the ability to overwrite original data, and are not required to utilize the protection of individual password

12、s. - The corresponding EIR further states: During discussions and lab demonstrations, it was determined that neither system prevents analysts from overwriting original raw data. A review of the software validation showed initial failures for modules demonstrating the ability to delete or overwrite d

13、ata. Documentation in the validation report stated that this capability could not be changed. During the laboratory demonstration, I observed the statement, "Data will be overwritten" with the option to ignore this. - In addition to the ability to overwrite original data, the analysts are

14、not required to utilize the protection of passwords since they are considered to have "limited access". I stated that each analyst needs to have their own password to access the system to help ensure data security and to track the usage by individuals.   事例：用來控制設(shè)備，產(chǎn)生數(shù)據(jù)，進(jìn)行校準(zhǔn)， 儲(chǔ)存原料

15、和成品檢驗(yàn)數(shù)據(jù)的實(shí)驗(yàn)室軟件的驗(yàn)證中沒有論證安全性。分析人員能夠改寫原始數(shù)據(jù)。沒有要求對(duì)個(gè)人密碼進(jìn)行保護(hù)相對(duì)應(yīng)的EIR狀態(tài)：在討論和實(shí)驗(yàn)室論證中發(fā)現(xiàn)，系統(tǒng)并不能防止分析人員改寫原始數(shù)據(jù)。軟件驗(yàn)證回顧表明記錄數(shù)據(jù)刪除和數(shù)據(jù)改寫的模塊最初就失靈了。驗(yàn)證報(bào)告文件中表明這種能力不能被改變。在實(shí)驗(yàn)室論證中，我看到不予理會(huì)“數(shù)據(jù)可以被修改”的聲明。除了修改原始數(shù)據(jù)的能力外，分析人員沒有要求保護(hù)密碼，盡管他們也認(rèn)為登陸要受到控制。我建議每個(gè)分析人員都需要用自己的密碼來登陸系統(tǒng)以確保數(shù)據(jù)安全及跟蹤個(gè)人使用情況W-191Keywords: Vendor software, software validation關(guān)

16、鍵詞：供應(yīng)商軟件，軟件驗(yàn)證  Primary deviations: vendor supplied computer software not validated,   主要錯(cuò)誤：供應(yīng)商提供未經(jīng)驗(yàn)證的軟件  Examples:   事例-The performance of the computer software has not been verified. Specifically your firm has not verified your computer software program in al

17、l aspects of their donor referral operations to ensure that electronic records are trustworthy, accurate and reliable. The related EIR further explained: The firm uses a computer software program called (brand name) that is manufactured by (vendor name). 計(jì)算機(jī)軟件性能未經(jīng)確認(rèn)，特別是你公司未確認(rèn)所有捐贈(zèng)轉(zhuǎn)診方面的計(jì)算機(jī)軟件程序以確保電子紀(jì)錄是

18、可信，準(zhǔn)確和可靠的。相關(guān)的EIR解釋：公司使用某公司生產(chǎn)的某軟件。- During the inspection, I asked if the computer software has been validation to assure that it performs for it's intended use. I was told that the software was validated by the manufacturer. The managing director provided me a copy of the letter the received

19、 from (the vendor). The letter indicated that the software was validated. She also the gave me a copy of validation information that was obtained from (the vendor) during the inspection.在檢查中，我問計(jì)算機(jī)軟件是否已驗(yàn)證，確保能實(shí)現(xiàn)預(yù)計(jì)的功能。答案是軟件已由生產(chǎn)商驗(yàn)證。管理者提供了一份供應(yīng)商的信件的復(fù)印件。信件表明軟件已驗(yàn)證。在檢查中，她還提供了從供應(yīng)商處獲得的驗(yàn)證信息的拷貝。- I told the mana

20、ging director I still need to see what they have done to validate the system since the computer was making a decision to accept or reject potential donors. The managing director and the Manager of the Communications Center told me that they were unaware they the company had to validate the software

21、because it was validated by (the vendor) and that was their reason for purchasing the version of software instead of the COTS (Commercial Off The Shelf) version of the software that is also manufactured by (the vendor).  我告訴管理者，由于由計(jì)算機(jī)決定接受或拒絕可能的捐贈(zèng)者，所以我需要了解他們?nèi)绾悟?yàn)證系統(tǒng)。管理者和交流中心的經(jīng)理告訴我他們沒有意識(shí)到他們必須對(duì)

22、供應(yīng)商驗(yàn)證過的軟件進(jìn)行驗(yàn)證。他們購(gòu)買這個(gè)版本的軟件而不是商業(yè)現(xiàn)成版，也是因?yàn)檫@個(gè)版本的軟件供應(yīng)商已經(jīng)驗(yàn)證過（商業(yè)現(xiàn)成版也由同一供應(yīng)商生產(chǎn)）。W-190Keywords: IQ, OQ, PQ, retrospective validation, legacy systems, no review of electronic records關(guān)鍵詞：IQ,OQ,PQ, 回顧性驗(yàn)證，遺贈(zèng)系統(tǒng)，沒有電子紀(jì)錄的回顧  Primary deviations: no validation of legacy systems, no formal change control. no de

23、sign control for customized software elements, no review of electronic records 主要錯(cuò)誤：沒有遺贈(zèng)系統(tǒng)的驗(yàn)證，沒有正式的變更控制，沒有對(duì)定制的軟件要素進(jìn)行設(shè)計(jì)控制，沒有電子紀(jì)錄的復(fù)核  Examples: 事例：- No IQ, OQ or PQ has been performed throughout the life of the system. No validation reports have been generated historically. 在系統(tǒng)的整個(gè)使用周期中沒有進(jìn)行IQ

24、,OQ,PQ。沒有驗(yàn)證報(bào)告。- Current efforts to retrospectively validate the system have progressed through the approval of an IQ protocol, however, this protocol has not yet been executed. OQ and PQ efforts have not yet been developed as part of these current validation efforts.現(xiàn)在的努力是對(duì)系統(tǒng)進(jìn)行回顧性驗(yàn)證，已批準(zhǔn)IQ草案，但還未實(shí)施。OQ

25、,PQ還未作為現(xiàn)階段驗(yàn)證的一部分。- The (system) has not been maintained under established procedures for change control. This is true throughout the life of this software application. 系統(tǒng)沒有在已建立的變更程序下進(jìn)行維護(hù)。在整個(gè)軟件使用過程中都是如此。- The firm has failed to generate or maintain design control documentation sufficient to define al

26、l customized elements making up the (system) configuration (i.e., functional or structural design documentation defining all program making up (the system)該公司未能產(chǎn)生或維護(hù)足夠的設(shè)計(jì)控制文件以定義所有構(gòu)成系統(tǒng)的定制的要素（比如：定義構(gòu)成系統(tǒng)的所有程序的功能性或結(jié)構(gòu)性設(shè)計(jì)）- Electronic records generated during manufacture of APIs were not reviewed prior to

27、release of validation lots or for any lots manufactured thereafter to include the most recently released API lot. 在驗(yàn)證批或之后生產(chǎn)的任何批次放行前沒有復(fù)核在生產(chǎn)APIs過程中產(chǎn)生的電子記錄。最近放行的批次也是如此。W-189Keywords: Microsoft Excel, Microsoft Word, Off-the-shelf software, Validation關(guān)鍵詞：微軟Excel, 微軟 Word, 現(xiàn)成軟件  Primary deviati

28、ons: Off-the shelf software not validated 主要錯(cuò)誤: 現(xiàn)成軟件沒有驗(yàn)證  Examples: 事例：Failure to assure that when computers or automated data processing are used as part of the production or quality system the manufacturer shall validate computer software for its intended use according to an established

29、protocol, as required by 21 CFR 820.70(i). 沒有按照21 CFR 820.70(i)要求制定草案來確保作為生產(chǎn)或質(zhì)量系統(tǒng)的一部分的計(jì)算機(jī)或自動(dòng)數(shù)據(jù)處理會(huì)被驗(yàn)證，以滿足計(jì)劃的使用目的。- Electronic records are used but there was no software validation. 使用電子記錄但軟件未經(jīng)驗(yàn)證。- No procedures are established to validate for its intended purpose the Microsoft Word or Microsoft Excel

30、 software used in creating and maintaining nonconformance records, product return records, internal audit corrective records, or corrective action records. 沒有制定程序來驗(yàn)證微軟Excel和微軟 Word 軟件，這些軟件計(jì)劃用在產(chǎn)生或維持不符合記錄，產(chǎn)品退回記錄，內(nèi)部審計(jì)糾正記錄或整改記錄。W-188Keywords: Laboratory, Electronic Audit Trail, Chromatographic integrati

31、on關(guān)鍵詞：實(shí)驗(yàn)室，電子審計(jì)追蹤，色譜綜合性能  Primary deviations: No or inadequate electronic audit trail, no audit trail for chromatographic reintegration 主要錯(cuò)誤：沒有或電子審計(jì)追蹤不夠，沒有色譜完整性能審計(jì)追蹤  Examples: 事例：- Operations that could affect the integrity of chromatographic data files are not controlled by elec

32、tronic audit trails that maintain who, why and what was changed to any given sample record能夠影響色譜數(shù)據(jù)文件的操作沒有被電子審計(jì)追蹤控制，這種跟蹤是顯示任何樣品紀(jì)錄為什么以及怎樣被改變的。- There are no records of user transactions when data is deleted, copied, renamed or purged當(dāng)數(shù)據(jù)被刪除，復(fù)制，重命名或者清除時(shí)沒有使用者操作記錄。- The firm can not determine if reintegra

33、tion of a sample occurred once or several times。公司沒有決定樣品重組是進(jìn)行一次還是幾次。W-187Keywords: Stability Testing, Quality Control Unit, Laboratory investigations, electronic audit trail, automated computer time-out, method validation, method transfer 關(guān)鍵詞：穩(wěn)定性測(cè)試, 質(zhì)控，實(shí)驗(yàn)室調(diào)查。電子審計(jì)追蹤，計(jì)算機(jī)自動(dòng)暫停，方法驗(yàn)證，方法轉(zhuǎn)移  Prima

34、ry deviations: Electronic audit trail not reviewed, electronic audit trail does not identify the the person who made the change, no automated computer time-out, operators and supervisors can delete raw data, raw data from contract testing labs not reviewed, proper functioning of established methods

35、not verified after modifications, no follow-up on unknown chromatographic peaks, failing impurity results not reported, no or inadequate training, responsibilities of quality control unit not in writing, inadequate cleaning and maintenance of equipment, no or inadequate failure investigation 主要錯(cuò)誤：電子

36、審計(jì)追蹤未復(fù)核，電子審計(jì)追蹤不能識(shí)別誰作了修改。沒有計(jì)算機(jī)自動(dòng)暫停，操作員和主管可以刪除原始數(shù)據(jù)，沒有復(fù)核合同實(shí)驗(yàn)室過來的數(shù)據(jù)，已建立方法的適當(dāng)?shù)墓δ茉诜椒ㄐ薷暮笪唇?jīng)確認(rèn)，沒有繼續(xù)跟進(jìn)未知色譜峰，沒有報(bào)告不合格的雜質(zhì)結(jié)果，沒有培訓(xùn)或培訓(xùn)不夠，沒有寫明質(zhì)控的職責(zé)，設(shè)備清潔和維護(hù)不夠，沒有故障調(diào)查或調(diào)查不夠  Examples: 事例：- Appropriate controls are not exercised over computers or related systems to assure that changes in master production and

37、control records are instituted only by authorized personnel沒有對(duì)計(jì)算機(jī)系統(tǒng)或相關(guān)系統(tǒng)進(jìn)行適當(dāng)控制以確保只有經(jīng)過授權(quán)的人才能制定主生產(chǎn)記錄- The audit trail generated within xxx does not truly reflect the identity of the responsible individuals. Individuals have been able to log on to the system under an other individuals account and make

38、changes which then show up on the audit trail to the first individual. 在xxx產(chǎn)生的電子審計(jì)追蹤不能真實(shí)反應(yīng)責(zé)任人的身份。個(gè)人可以用其他人的賬號(hào)登陸系統(tǒng)并作修改，電子審計(jì)追蹤顯示的是其他人作了修改。- Changes made by PERSON 1 are attributed to PERSON 2 on the (electronic) audit trail.第一個(gè)人作的修改在審計(jì)追蹤上歸于第二個(gè)人- The firm's review of laboratory data does not inc

39、lude the audit trail/revision history to determine if unapproved changes have been made. 公司實(shí)驗(yàn)室數(shù)據(jù)的復(fù)核沒有包括用來決定是否有未經(jīng)批準(zhǔn)的變更的審計(jì)追蹤/版本歷史。- The xxx system computers in the lab do not time-out. If an employee fails to log off a computer and walks away other individuals can easily access the computer under the

40、first employees account.實(shí)驗(yàn)室中的Xxx 系統(tǒng)計(jì)算機(jī)不能自動(dòng)暫停，如果一個(gè)員工沒有退出計(jì)算機(jī)就走開的話，其他員工可以很容易地用第一個(gè)員工的賬戶進(jìn)入計(jì)算機(jī)。-  The firm routinely assigned method validation chemists, lead chemist, and laboratory supervisors system administrator status with the ability to modify and delete raw data files in the HPLC data acq

41、uisition system 在HPLC數(shù)據(jù)獲取系統(tǒng)中，公司已經(jīng)驗(yàn)證的方法，分析人員，主分析師，實(shí)驗(yàn)室主管和系統(tǒng)管理員能夠修改和刪除原始數(shù)據(jù)文件。- Records maintained of any modifications of an established method employed in testing do not include the data to verify that the modification produced results that are at least as accurate and reliable for the material being

42、tested as the established method 在測(cè)試中使用的修改后方法的記錄沒有包括用來確認(rèn)修改方法至少能產(chǎn)生和原有方法同樣精確和可靠結(jié)果的數(shù)據(jù)。- The firm does not receive and review all raw data from contract testing laboratories 公司沒有收到和復(fù)核來自合同實(shí)驗(yàn)室的所有數(shù)據(jù)。- The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and

43、documented檢測(cè)方法的精確性，靈敏度，專屬性和重復(fù)性未經(jīng)驗(yàn)證并記錄- The firm failed to perform finished product test method transfers for 34 products34個(gè)產(chǎn)品的成品檢測(cè)方法轉(zhuǎn)移沒有進(jìn)行- The firm has failed to perform method validations, method verifications, or method transfers for any of the laboratory test methods used to test active pharmace

44、utical ingredients 公司沒有對(duì)用來檢測(cè)APIs的所有實(shí)驗(yàn)室方法進(jìn)行方法驗(yàn)證，確認(rèn)或轉(zhuǎn)移。W-186Keywords: Method validation, method transfer, process control procedure, sampling plans, test procedures關(guān)鍵詞：方法驗(yàn)證，方法轉(zhuǎn)移，過程控制程序，取樣計(jì)劃，檢測(cè)程序  Primary deviations: Analytical methods transferred without method transfer or revalidation proto

45、col, no or inadequate product specifications, no or inadequate sampling plans. 主要錯(cuò)誤：分析方法轉(zhuǎn)移時(shí)無轉(zhuǎn)移或再驗(yàn)證草案。沒有產(chǎn)品規(guī)格或不全，沒有取樣計(jì)劃或不合適  Examples: 事例：- Failure to establish production and process control procedures designed to assure your drug products have the required identity, strength, quality and p

46、urity. For example, the validation protocols for xxx and xxx do not provide assurance that the manufacturing process quality throughout the production process沒有建立生產(chǎn)和過程控制程序以保證藥品符合同一性，強(qiáng)度，質(zhì)量和純度方面的要求。例如：xxx 和 xxx的驗(yàn)證草案不能保證整個(gè)生產(chǎn)過程的生產(chǎn)質(zhì)量- failure to establish scientifically sound and appropriate specificatio

47、ns, standards, sampling plans, and test procedure designed to assure products conform to appropriate standards of identity, strength, quality, and purity. For example, there is no scientific justification for testing 30 capsules for content uniformity during process validation. 沒有建立聽起來很科學(xué)很合適的規(guī)格，標(biāo)準(zhǔn)，取

48、樣計(jì)劃和測(cè)試程序以保證藥品符合同一性，強(qiáng)度，質(zhì)量和純度方面的要求。例如：在驗(yàn)證過程中檢測(cè)30個(gè)膠囊的裝量差異沒有科學(xué)依據(jù)。Failure to establish and document the accuracy, sensitivity and reproducibility of test methods employed. for example, methods that were validated at one facility and transferred to xxx site are being used without method transfer or revali

49、dation protocol,. 沒有記錄所采用方法的精確度，靈敏度和重復(fù)性。例如：在一個(gè)地點(diǎn)驗(yàn)證的方法轉(zhuǎn)移到另一個(gè)地點(diǎn)時(shí)，沒有進(jìn)行方法轉(zhuǎn)移或者再驗(yàn)證方案。W-185Keywords: Software and computer system validation, back-up, limited access, audit trail, data encryption, accurate copies關(guān)鍵詞：軟件和計(jì)算機(jī)系統(tǒng)驗(yàn)證，備份，限制登陸，審計(jì)追蹤，數(shù)據(jù)加密，精確拷貝  Primary deviations: Inadequate storage and bac

50、k-up, missing ability to discern invalid or altered electronic records, access to computer records without unique user ID and password, no or inadequate validation, inaccurate copies of electronic records. 主要錯(cuò)誤：不適當(dāng)?shù)拇鎯?chǔ)和備份，不能辨別無效或改編的電子記錄，沒有個(gè)人專用的用戶名和密碼來訪問計(jì)算機(jī)記錄。電子記錄拷貝不準(zhǔn)確  Examples:事例 -Failure

51、to store records so as to minimize deterioration, prevent loss and back up of automated data processing systems 沒有存儲(chǔ)記錄來最小化毀壞風(fēng)險(xiǎn)，預(yù)防丟失和數(shù)據(jù)自動(dòng)處理系統(tǒng)的備份。-  The electronic data did not correlate with the paper records; you had not established an electronic data back-up procedure; and finally, data w

52、as copied onto the server from one system to the next via floppy: therefore, no limited access or data protection had been established電子數(shù)據(jù)與紙面記錄不相關(guān)聯(lián)，你們沒有建立電子數(shù)據(jù)備份程序，數(shù)據(jù)從一個(gè)系統(tǒng)到另一系統(tǒng)的拷貝非常松散,所以沒有限制登陸和保護(hù)數(shù)據(jù)。Failed to encrypt and/ or physically secure your data back-up system to comply with the requirements to

53、 prevent deterioration or deletion of the analyzer data沒有給數(shù)據(jù)備份系統(tǒng)加密或物理保護(hù)以符合預(yù)防分析數(shù)據(jù)被毀壞和刪除的要求。- Failure to adequately validate the intended use of this PC and its software沒有充分驗(yàn)證計(jì)算機(jī)和軟件的計(jì)劃用途- The dedicated PC redacted attached to the redacted was not secure in that access to the data on redacted was not g

54、ranted by a unique username and password or equivalent method計(jì)算機(jī)上用于編寫的功能在訪問數(shù)據(jù)方面不安全，不是通過個(gè)人專用的用戶名和密碼或同等的方法。- there as no documentation associated with the electronic data for whom was responsible for collection of the analytical results as several quality control personnel have access to the redacted

55、no software changes in the study data could be detected as there was no audit trail capability; and finally, the electronic data did not correlate with the paper records.沒有與電子記錄相關(guān)聯(lián)的誰負(fù)責(zé)收集分析結(jié)果和幾個(gè)質(zhì)量控制人員能夠編輯的文件。在研究數(shù)據(jù)中沒有軟件變化可以被檢測(cè)出，即沒有審計(jì)追蹤能力，最后電子數(shù)據(jù)與紙面記錄不相關(guān)聯(lián)。- your response and have concluded that it is in

56、adequate because no system validation was conducted to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records 你們已經(jīng)做出系統(tǒng)驗(yàn)證不充分的結(jié)論，因?yàn)橄到y(tǒng)驗(yàn)證沒有確保精確性，可靠性，持續(xù)使用能力和識(shí)別無效及更改記錄的能力W-184Keywords: IRB, clinical investigations, review procedures關(guān)鍵詞：IRB，臨床研究

57、，復(fù)核程序  Primary deviations: Failure to follow required written procedures, failure to use expedited review procedures. 主要錯(cuò)誤：沒有遵循已定規(guī)程，沒有采用官方的復(fù)核程序  Examples: 事例：- Review of the inspection report indicates that the IRB failed to follow written procedures for conducting initial and co

58、ntinuing review of research檢查報(bào)告復(fù)核顯示IRB沒有遵循已定規(guī)程對(duì)研究進(jìn)行起始復(fù)核和持續(xù)復(fù)核。- The IRB's written procedures state that "the IRB shall consist of thirteen (13) members." Since October 12, 2005, the IRB membership roster has listed only 12 members.IRB已定規(guī)程聲明：IRB有十三個(gè)成員，但自從2005年10月12號(hào)開始，IRB成員表上只列了12個(gè)成員

59、。- The IRB's written procedures state that "meetings will be held on an as-needed basis, but no less than quarterly." However, the IRB records indicate that the IRB has met at intervals greater than three months on four occasions since August 2004.IRB已定規(guī)程聲明：會(huì)議按需召開，但不少于每季度一次，IRB記錄表明IRB從2004年8月以來有四次會(huì)議間隔在三個(gè)月以上。- Failure to use expedited review procedures only for certain kinds of research involving no more than minimal risk or for minor changes in approved resear