FDA認(rèn)證483條款缺陷項(xiàng)中英對(duì)照

1、FDA Warni ng Letters, Form 483 Observati ons andEstablishme nt In specti on Reports PreviewFDA警告文字，來(lái)自483觀測(cè)資料和預(yù)先檢查報(bào)告Importa nt: Warni ng letters and other FDA in spect ion docume ntatio nshould be in terpreted in the con text of full content. Just looki ng atextracts may be misleadi ng. And sometimes

2、 they in clude good advicefrom the FDA not men ti oned in the extracts.重要性：警告文字和其他的FDA檢查文件必須說(shuō)明，根據(jù)上下文包括全部?jī)?nèi)容。 僅是看摘錄可能被誤解。并且有時(shí)要包括從FDA那里征求好的建議，而不是只提到摘錄。FDA 483 In spectio nal Observatio ns, EIRs & Warni ng Letters -Preview keywords and excerptsTypeContent&deviati onsKeywords, selected examples (not comp

3、lete).Click on D to view, print and/or download the files with full text. (In this Preview Mode the click will li nk you to the order form) Tell your frie nds about this page !FDA檢查報(bào)告，EIRS和警告文字-預(yù)覽關(guān)鍵詞和摘錄。類(lèi)型內(nèi)容和目錄關(guān)鍵詞，選擇事例(不用完整) 盡力畫(huà)出“ D”來(lái)觀察、印刷和/或下載所有文件的全部?jī)?nèi)容 。(在這部分預(yù)覽方式中，CLICK將使你形成定貨表格。)48385 itemsW-156DK

4、eywords: Water systems, diagrams, process validati on, clea ning validati on, batch record review, trai nin g, i nstrume nt calibrati on, reserve samples, testing, product specification, distribution records, analytical method, USP sta ndard, failure in vestigati on, labeli ng, SOPs* 483關(guān)鍵詞：水系統(tǒng)，圖表，過(guò)

5、程確認(rèn)，清潔確認(rèn)，一批記 錄：有回顧，培訓(xùn)，儀表校正，儲(chǔ)備樣本，檢測(cè)，制品技術(shù) 規(guī)格，分析方法，USP標(biāo)準(zhǔn)，故障調(diào)查，標(biāo)簽，SOPS* Primary deviati ons:miss ing diagrams, no in stallati on qualificati on,no operati on qualificati on, no batch record review, in adequate GMP training, in adequate equipme nt calibrati on, in adequate storage of reserve samples, SOP

6、s not approved, in adequate procedures for sampli ng and testi ng* Examples:-There was no diagram of the water system-Batch records not reviewed by QC,-Routine calibration not performed according to a written program-Con ductivity meters not calibrated to an NIST traceable device-Batch records lack

7、a descripti on of n ame of the equipme nt-No refere nee in an alytical method to recog ni zed sta ndard method.-Curre nt SOPs not reviewed and approved by QCUW156 。主要錯(cuò)誤：缺少圖表，無(wú)安裝資格，無(wú)操作資格，無(wú)回 顧記錄，GMP培訓(xùn)不充分，設(shè)備刻度不清楚，儲(chǔ)備事例不充分， SOP沒(méi)被證明，取樣和檢測(cè)程序不充分。事例：-水系統(tǒng)沒(méi)有圖表-大批記錄沒(méi)有被質(zhì)控回顧-常規(guī)表格沒(méi)有根據(jù)書(shū)面程序執(zhí)行-電導(dǎo)計(jì)沒(méi)有根據(jù)NIST可追蹤裝置校準(zhǔn)-大批記錄

8、缺少設(shè)備描述名字-沒(méi)有根據(jù)分析方法涉及可識(shí)別的標(biāo)準(zhǔn)方法-當(dāng)前SOPS沒(méi)有被QCU回顧和驗(yàn)證483 Keywords: Electr onic records, electro nic sig natures,Part 11 , Equipme ntcalibration, equipment qualification, certificate of analysis, review ofW-155records關(guān)鍵詞：電子記錄，電子信號(hào)，設(shè)備刻度，分析證書(shū)，回顧記錄Primary deviati ons:missi ng Certificate of An alysis, i nadequa

9、teequipment calibration, failure to review production and control records by QA, no recalibration after equipment move.W-155。主要錯(cuò)誤：缺少分析證書(shū)，設(shè)備刻度不適當(dāng)，缺少質(zhì)保的產(chǎn)品回顧和控制記錄。當(dāng)設(shè)備移動(dòng)后沒(méi)有校準(zhǔn)。 Examples:-Failure to establish laboratory con trols which in elude the calibrati on of in strume nts, apparatus, gauges and reco

10、rd ing devices at suitable in tervals in accorda nee with an established writte n program containing specific directi ons, schedules, limits for accuracy and precisi on and remedial acti on in the eve nt the accuracy an d/or precisi on limits are not met 21 CFR 211.160(b)(4).-Specifically, your firm

11、 does not have a Certificate of Analysis (COA) for .-The procedure is un clear and is incon siste nt with the man ufacturers recomme ndati on which advises to calibrate the redactedOxyge nAn alyzer each time the an alyzer is moved.-Failure to rout in ely calibrate, in spect, or check automatic, mech

12、a ni cal, or electr onic equipme nt accord ing to a writte n program desig ned to assure proper performa nee 21 CFR 211.68(a).Specifically, your firm has not performed any equipment qualification on the mobile cryogenic pumping system. 事例：* -缺少建立實(shí)驗(yàn)控制，包括器械刻度、規(guī)格、記錄裝置在適 當(dāng)?shù)木嚯x，根據(jù)建立的書(shū)面表格：有特殊方向、時(shí)間表、限 制的精確度

13、、當(dāng)重大事件發(fā)生時(shí)的矯正措施和/或精確度，所 有這些都要滿(mǎn)足。21CFR211。160( b)( 4)-特殊性，你的公司沒(méi)有分析證明書(shū)(COA)為了.-程序不清晰和沒(méi)包括制造商推薦信，氧分析器的每次移動(dòng) 沒(méi)有校準(zhǔn)。-缺乏常規(guī)校準(zhǔn)、檢查、或自動(dòng)核對(duì)、機(jī)械核對(duì)，或根據(jù)書(shū) 面程序設(shè)計(jì)電子設(shè)備來(lái)確保正確的執(zhí)行。21CFR211.68(a)*特殊性，你的公司還沒(méi)有執(zhí)行設(shè)備資格在可移動(dòng)的低抽吸泵 系統(tǒng)中。Warning Keywords: Equipment calibration, equipment qualification, certificate ofDLetteran alysis, revi

14、ew of recordsgjgjft 警告關(guān)鍵詞：設(shè)備刻度，設(shè)備規(guī)格，分析證書(shū)，記錄回顧 Primary deviati ons:missi ng Certificate of An alysis, i nadequateW-154equipme nt calibrati on, failure to review producti on and con trol recordsby QA, no recalibrati on after equipme nt move.* 主要錯(cuò)誤：缺少分析證書(shū)，設(shè)備刻度缺少，缺少質(zhì)保的回顧生產(chǎn)記錄和控制記錄，設(shè)備移動(dòng)后沒(méi)有校準(zhǔn)。-Failure to e

15、stablish laboratory con trols which in elude the calibrati on of in strume nts, apparatus, gauges and record ing devices at suitable in tervals in accorda nee with an established writte n program containing specific directi ons, schedules, limits for accuracy and precisi on and remedial acti on in t

16、he eve nt the accuracy an d/or precisi on limits are not met 21 CFR 211.160(b)(4).-Specifically, your firm does not have a Certificate of Analysis (COA) for .-The procedure is un clear and is incon siste nt with the man ufacturers recomme ndati on which advises to calibrate the redacted Oxyge n An a

17、lyzer each time the an alyzer is moved.-Failure to rout in ely calibrate, in spect, or check automatic, mecha ni cal, or electr onic equipme nt accord ing to a writte n program desig ned to assure proper performa nee 21 CFR 211.68(a).Specifically, your firm has not performed any equipment qualificat

18、ion on the mobile cryogenic pumping system.* 事例：* 事例：-缺少建立實(shí)驗(yàn)控制，包括器械刻度、規(guī)格、記錄裝置在適 當(dāng)?shù)木嚯x，根據(jù)建立的書(shū)面表格：有特殊方向、時(shí)間表、限 制的精確度、當(dāng)重大事件發(fā)生時(shí)的矯正措施和/或精確度，所 有這些都要滿(mǎn)足。21CFR211。160( b)( 4)* -特殊性，你的公司沒(méi)有分析證明書(shū)(COA)為了.-程序不清晰和沒(méi)包括制造商推薦信，氧分析器的每次移動(dòng) 沒(méi)有校準(zhǔn)。-缺乏常規(guī)校準(zhǔn)、檢查、或自動(dòng)核對(duì)、機(jī)械核對(duì)，或根據(jù)書(shū) 面程序設(shè)計(jì)電子設(shè)備來(lái)確保正確的執(zhí)行。21CFR211.68(a)*特殊性，你的公司還沒(méi)有執(zhí)行設(shè)備資格在可

19、移動(dòng)的低抽吸泵 系統(tǒng)中。-Warning Keywords: capa, process validation, change control, quality systemsLetter警告信關(guān)鍵詞：過(guò)程確認(rèn)，變更控制，質(zhì)量系統(tǒng)Primary deviati ons:in adequate corrective and preve ntive acti ons,in adequate process validati on, in adequate cha nge con trol procedureW-153主要錯(cuò)誤：缺少足夠的矯正和預(yù)防措施、過(guò)程確認(rèn)、變更控制程 序。Examples:-

20、Failure to establish and maintain an adequate corrective and preventive action procedure which ensures identification of actions n eeded to correct and preve nt the recurre nee of noncon form ing product and other quality problems, as required by 21 CFR 820.100(a)(3).-Failure to validate cha nges to

21、 your man ufacturi ng process with a high degree of assura nee to en sure that specified requireme nts are met as required by 21 CFR 820.75(c).-Validation did not include verification assurance that the changes did not affect the device-Failure to ide ntify the accepta nce status of product througho

22、ut man ufacturi ng, packagi ng, labeli ng, and servic ing of the product to en sure that only product which has passed the required accepta nce activities is distributed or used.* 事例：-缺少建立和維持足夠的矯正和預(yù)防程序，這能保證統(tǒng)一行 為所需糾正和預(yù)防非一致性的產(chǎn)品和其他質(zhì)量問(wèn)題再次發(fā) 生，正如 21 CFR 820.100(a)(3).所需的。21-對(duì)于你的產(chǎn)品生產(chǎn)過(guò)程缺乏有效的變更保證來(lái)保證特殊需求，正如CF

23、R 820.75(c).所需。-確認(rèn)沒(méi)有包括確認(rèn)保證，這些改變是否會(huì)影響裝置。-缺乏貫穿于生產(chǎn)、包裝、標(biāo)簽、和產(chǎn)品服務(wù)的統(tǒng)一可接受的標(biāo)準(zhǔn)，來(lái)確保只有產(chǎn)品通過(guò)所需要的可接受的行為才被分發(fā)和應(yīng)用。Warning Keywords: root cause, capa, compliant handling, management Letter respon sibility警告信關(guān)鍵詞：根本原因，CAPA，抱怨處理，操作責(zé)任 f * Primary deviations:no root cause analysis, insufficient complainthan dli ngW-152主要錯(cuò)誤

24、：沒(méi)有分析根本原因，不足的抱怨的處理。* Examples:-You are resp on sible for in vestigati ng and determ ining the causes of the violations identified by the FDA. You also must promptly initiate perma nent corrective and preve ntive acti on of your quality system. Failure to promptly correct these deviati ons may result

25、 in regulatory acti on being in itiated by the FDA without further no tice. These acti ons include, but are not limited to, seizure, injunction, and/or civil pen alties. Additi on ally, no premarket submissi ons for Class III devices to which QSR deficie ncies are reas on ably related will be cleare

26、d un til the violations have been corrected. Also, no requests for Certificates to Foreig n Gover nments will be approved un til the violati ons related to the subject devices have bee n corrected.- You have failed to establish compla int han dli ng procedures sufficie ntto en sure that all compla i

27、nts are docume nted and processed in a un iform and timely ma nner, as required by 21 CFR 820.198(a).-Management with executive responsibility has failed to ensure that an adequate and effective quality system has bee n fully impleme nted and mai ntai ned at all levels, as required by 21 CFR 820.20-

28、You have also failed to establish a policy of overall inten ti ons and directi on of your firm with respect to quality* 事例：-你有責(zé)任調(diào)查和決定這些違反FDA的一致性原因。對(duì)于你的質(zhì)量系統(tǒng)你也必須迅速的發(fā)起持久的糾正和預(yù)防行動(dòng)。缺乏迅速的糾正這些錯(cuò)誤 可能導(dǎo)致調(diào)整的行為開(kāi)始沒(méi)有被FDA進(jìn)一步發(fā)現(xiàn)。這些行為包括，但不限于，沒(méi)收、命令，和/或全民的處罰。,另外，premarket 提議為QSR缺乏是合理地相關(guān)的類(lèi)III設(shè)備不會(huì)被清除直到侵害被改正了同樣，沒(méi)有要求證明對(duì)外國(guó)政府批

29、準(zhǔn)直到侵害與附屬的設(shè)備被改正了* -你已缺乏建立足夠的抱怨操作程序來(lái)確保所有的抱怨是有一致和及時(shí)操作的文件證明和處理，正如21 CFR 820.198(a).所需。-缺乏以行政責(zé)任處理來(lái)確保足夠的和有效的質(zhì)量系統(tǒng)，而這個(gè)系統(tǒng)需要貫徹和保持在所有水平，正如21 CFR 820.20 所需。-你也缺少建立關(guān)于公司質(zhì)量的全面的意圖和指導(dǎo)的政策。Warning Keywords: stability testing, failure investigation, batch reprocessing.Lettermissi ng recordsW-151警告信關(guān)鍵詞：穩(wěn)定性實(shí)驗(yàn)，故障調(diào)查，批物料的回收

30、，丟失的記錄* Primary deviati ons:No adequate stability test program, missi ngfailure in vestigati on, miss ing procedure for the reprocess ing ofbatches, miss ing records regard ing un expla ined discrepa ncies 主要錯(cuò)誤：沒(méi)有足夠的穩(wěn)定性實(shí)驗(yàn)，故障調(diào)查，批物料回收丟失的手續(xù),關(guān)于無(wú)法解釋的差異缺失手續(xù)。* Examples:-You have failed to establish an adeq

31、uate stability testing program to determine appropriate expiration dates for all your drug products (21 CFR 211.166(a) and (b)-You have failed to investigate failures of a batch or any of its components to meet their specifications (21 CFR 211.192).-You do not maintain any written records regarding

32、unexplained discrepa ncies and batch failures as required by 21 CFR 211.192-Batches are routi nely reprocessed whe n in itial release specificati ons fail.-None of the stability failures, described above, were the subject of aninvestigation as required by 21 CFR 211.192-You have not established writ

33、te n procedures for the reprocess ing of batches to en sure that they will con form to all established specifications (21 CFR 211.115).* 事例：* -對(duì)于藥物生產(chǎn)缺乏建立足夠的穩(wěn)定性實(shí)驗(yàn)來(lái)解釋生產(chǎn)中的數(shù)據(jù)。(21CFR 211.166(a) and (b)一批物料或其中的一部分缺乏失誤調(diào)查來(lái)滿(mǎn)足他們的特殊性。(21 CFR211.192).-關(guān)于無(wú)法解釋的差異和和批物料沒(méi)有記錄下來(lái)，正如21 CFR 211.192所提。* -當(dāng)開(kāi)始發(fā)布的說(shuō)明錯(cuò)誤時(shí)沒(méi)有例行公事

34、的修改-沒(méi)有穩(wěn)定性的錯(cuò)誤，就向上文所描述的，也是一種客觀的調(diào)查，正如21 CFR 211.192 所提-對(duì)于所有回收的物料沒(méi)有建立書(shū)面程序來(lái)符合所有建立的說(shuō)明。(21CFR 211.115).Warning Keywords: CAPA, complaints, audits, document control, quality system,Lettertrai ningW-150警告信 關(guān)鍵詞：CAPA，抱怨，文件控制，質(zhì)量系統(tǒng)，培訓(xùn)* Primary deviati ons:No or in adequate CAPA system, in adequatecompla int han

35、dli ng procedures,no quality audits, in adequateorga ni zati onal structure, in adequate docume nt con trol, failure to review effective ness of quality system by man ageme nt with executive resp on sibility, in sufficie nt pers onnel with n ecessary educati on. 主要錯(cuò)誤：沒(méi)有或缺乏足夠的CAPA系統(tǒng)、不適當(dāng)?shù)谋г固幚硐到y(tǒng)，沒(méi)有質(zhì)量審核

36、，缺乏足夠的組織結(jié)構(gòu)，缺乏足夠的文件控制，沒(méi)有通過(guò)行 政責(zé)任來(lái)回顧有效的質(zhì)量系統(tǒng)，個(gè)人缺乏足夠的必需教育。* Examples:Significant deviations include, but are not limited to, the following-An alyz ing processes, work operati ons, compla in ts, retur ned product and other sources of quality data to ide ntify existi ng and pote ntial causes of nonconformi

37、ng product-In vestigati ng the cause of noncon formities relati ng to product, processes, and the quality system-Identifying the actions needed to correct and prevent recurrence of nonconforming product and other quality problems-Verifying or validating the CAPA to ensure that such action is effecti

38、ve and does not adversely affect the fini shed device* 事例：有意義的錯(cuò)誤包括，但不是僅限于以下方面：-分析方法，工作業(yè)務(wù)，抱怨，返回產(chǎn)品和其他來(lái)源，有通 過(guò)質(zhì)量數(shù)據(jù)識(shí)別不合格的產(chǎn)品存在的和潛在的錯(cuò)誤。-調(diào)查相關(guān)產(chǎn)品、程序、和其他質(zhì)量系統(tǒng)不一致的原因。* -檢驗(yàn)和確認(rèn)CAPA來(lái)確保這樣的做法是有效的而不是由于 已完成的裝置產(chǎn)生相反的作用。Warning Keywords: API, testing, impurity testing, supplier testing, certificate ofDLetter analysis, sol

39、vent recovery, labeling system警告信關(guān)鍵詞：API，測(cè)試，混合物測(cè)試，廠商測(cè)試，證書(shū)分析，溶解性恢復(fù)，標(biāo)簽系統(tǒng)。Primary deviati ons:In sufficie nt test ing of in dividual batches, supplierW-149testi ng not verified, no procedures for solve nt recovery, in adequateproof of incoming labels. 主要錯(cuò)誤：個(gè)別產(chǎn)品沒(méi)有足夠測(cè)試，供應(yīng)商測(cè)試沒(méi)有校驗(yàn)，沒(méi)有程序恢 溶解性，引入的標(biāo)簽沒(méi)有足夠的證據(jù)。*

40、Examples:-The laboratory did not have an adequate impurity profile that ide ntifies orga nic, inorganic and solve nt impurities to mon itor unidentified and apparent impurities in the API-The microbiological laboratory fails to document the lot number and expiry date of xx-The reliability of the sup

41、pliers certificate of analysis (COA) was not established in that a complete analysis was not performed with the COA at the appropriate in tervals.-Procedures for solve nt recovery have not bee n established to en sure that solve nts are con trolled and mon itored-Incoming labels received from the ve

42、n dor are not proofed aga inst the master label* 事例：-實(shí)驗(yàn)室沒(méi)有雜質(zhì)分布圖分辨有機(jī)物，無(wú)機(jī)物，溶解混合物 來(lái)監(jiān)控未經(jīng)確認(rèn)的和外觀雜質(zhì)。-分析提供者證書(shū)的的可靠性不是建立在已完成的分析基礎(chǔ) 上，在適當(dāng)?shù)臅r(shí)間間隔是否符合COA。* -溶解能力的恢復(fù)程序還沒(méi)有建立來(lái)確保溶劑可控制和監(jiān) 控。*收到的引入標(biāo)簽沒(méi)很好的控制。Letter警告信Warning Keywords: API, testing, raw data, failure investigations, equipment design, English language, equipm

43、ent maintenance關(guān)鍵詞：API，測(cè)試，原始數(shù)據(jù)，失誤調(diào)查，設(shè)備設(shè)計(jì)，英語(yǔ)，設(shè)備 維護(hù) Primary deviati ons:In sufficie nt test ing of in dividual batches, in sufficie ntW-148record ing of raw data, in adequate failure in vestigati on, in adequateequipme nt desig n, in adequate equipme nt maintenance* 主要錯(cuò)誤：?jiǎn)为?dú)一批貨物沒(méi)有足夠測(cè)試，原始數(shù)據(jù)記錄不足，錯(cuò)誤調(diào)查不 足，

44、設(shè)備設(shè)計(jì)不足，設(shè)備維護(hù)不足 Examples:-The in dividual batches are not tested for residual solve nts-Laboratory records do not in clude all raw data. For example, weights determ ined duri ng the preparati on of sta ndard soluti ons were not recorded-Critical producti on deviati ons may not have bee n in vestigated

45、 and docume nted.-Producti on equipme nt was not desig ned to mini mize con tam in ati on-Equipme nt was not maintained in an adequate state of repair.-If you whish to to continue to ship APIs to the Un ited states, you should evaluate all equipme nt and writte n procedures and your employees adhere

46、 nee to written procedures, for complia nee with this sta ndards.-Failure to promptly correct these deficiencies may result in the refusal to permit entry of these APIs or finished products made from these APIs into the United States.-Please submit docume ntati on, with En glish tran slati on, of th

47、ese correcti ons.* 舉例：-單獨(dú)一批貨物沒(méi)有經(jīng)殘留溶劑檢驗(yàn)。-實(shí)驗(yàn)記錄沒(méi)有包括所有所有原始數(shù)據(jù)。例如，重量設(shè)計(jì)在解 決標(biāo)準(zhǔn)準(zhǔn)備時(shí)沒(méi)有記錄。* -重要生產(chǎn)裝置沒(méi)有調(diào)查和備有證明文件。-設(shè)備在完好維修狀態(tài)下沒(méi)有很好的維護(hù)。-如果你希望繼續(xù)裝運(yùn)APIS到美國(guó)，為了適應(yīng)許多標(biāo)準(zhǔn)，你必 須估計(jì)所有設(shè)備和書(shū)面手續(xù)和雇員堅(jiān)持書(shū)面手續(xù)。如果沒(méi)有迅速的改正這些不足可能會(huì)導(dǎo)致拒絕接受這些APIS或產(chǎn)品完成，這會(huì)使這些APIS進(jìn)入美國(guó)。-請(qǐng)?zhí)峤桓恼挠⒄Z(yǔ)文件，Warning Keywords: audits, CAPA, risk assessment, complaint handling, v

48、alidation, testLetterequipme nt, training警告信 關(guān)鍵詞：審核，CAPA，風(fēng)險(xiǎn)評(píng)估，抱怨處理，設(shè)備測(cè)試，培訓(xùn) Primary deviati ons:no audits of records, in adequate validati on ofworkstati on test equipme nt, i nadequate complia nt han dli ng,W-147in adequate procedures for CAPA, in adequate risk assessme nt. 主要錯(cuò)誤：沒(méi)有審核記錄，沒(méi)有充分確認(rèn)工作站測(cè)試設(shè)備

49、，沒(méi)有完全處理好抱怨，對(duì)于 CAPA沒(méi)有充足的手續(xù)，沒(méi)有充分的風(fēng)險(xiǎn)評(píng)估 Examples:-There is no in dicati on that your firm con ducted periodic checks or audits of the records during this time to assure the validity of the data.-Failure to establish and main tain procedures for impleme nting corrective and preve ntive acti ons (CAPA ) t

50、o in clude requireme nts for an alyz ing processes, work operati ons, con cessi ons, quality audit reports, quality records, service records, compla in ts, retur ned product, and other sources of quality data to ide ntify existi ng and pote ntial causes of nonconforming product, or other quality pro

51、blems, as required by 21 CFR 820.100 (a)-For example, your firm performed risk assessme nts for product failures without documenting how the severity or likelihood of occurre nee used in the assessme nt was determ in ed, in violati on of your own procedures.-For example, the validati on of the works

52、tati on test equipme nt used as part of the final device testing system; did not include a process capability challe nge, did not en sure that the test equipme nt used was capable of fun cti oning as n ecessary to capture results at both the high and low ends of the test specificati ons, and did not

53、 in clude challe nges with known failures to en sure the equipme nt detected fault con diti ons* 事例：* -沒(méi)有跡象表明你的公司進(jìn)行定期檢查或?qū)徲?jì)這些記錄，來(lái)確保數(shù)據(jù)的有效性。-缺乏建立和保持程序，這需要改正和預(yù)防措施的工具，這包括維修的分析程序，工作操作，讓步，返修品，或其他的質(zhì)量數(shù)據(jù)資源，以此來(lái)鑒 別現(xiàn)在和潛在的不合格產(chǎn)品存在的原因，或其他質(zhì)量問(wèn)題，正如.21 CFR820.100(a)-例如，確認(rèn)工作站測(cè)試設(shè)備作為最后測(cè)試系統(tǒng)的一部分；不包括性能測(cè)試，不能保證過(guò)去的測(cè)試設(shè)備有能力發(fā)揮作用，來(lái)

54、獲得所有高水 平和低水平測(cè)試規(guī)格的結(jié)果，不包括熟知的錯(cuò)誤，來(lái)確保設(shè) 備察覺(jué)錯(cuò)誤情況。Warnin Keywords:risk an alysis, desig n validati on, cha nge con trol, software test ing.g Letter警告acceptance criteria, quality control, installation qualification, inspection, supplier assessme nt關(guān)鍵詞：風(fēng)險(xiǎn)評(píng)估，設(shè)計(jì)確認(rèn)，變更控制，軟件測(cè)試，接受標(biāo)準(zhǔn)， 質(zhì)量控制，安裝控制，檢查，廠商評(píng)估 Primary devia

55、ti ons:no procedures for validati ng the device desig n,W-146no formal risk an alysis for software cha nges, no procedures forfini shed device accepta nce, in adequate in stallati on, in adequate in specti on, no procedures for supplier assessme nt.主要錯(cuò)誤：沒(méi)有裝置設(shè)計(jì)的確認(rèn)手續(xù)，對(duì)于軟件變更沒(méi)有正式 的風(fēng)險(xiǎn)評(píng)估，沒(méi)有完成的可接受裝置的程序，沒(méi)有充

56、分的檢 查，供應(yīng)商沒(méi)有評(píng)估手續(xù)。 Examples:-Failure to establish and maintain adequate procedures for validat ing the device desig n to en sure that the device con forms to user n eeds and inten ded uses and in clude risk an alysis, as required by 21 CFR 820.30(g) (FDA 483, Item 151.* 事例：-For example, a formal risk

57、analysis of the original system design and software cha nges to correct software bugs that caused in correct fun cti on ality or performa nce problems, and to enhance the product, has not bee n docume nted. Although your software release no tes briefly describe the nature of unresolved software bugs in a particular software vers ion, they do not expla in the impact of these software bugs on user n eeds and inten ded uses. For example, in the workflow release no tes, dated 6/24/04, software vers ion 2.Otr17 described that the scores for the left eye and