安博电竞-FDA鍙戝竷2020骞村害缂洪櫡姹囨€绘姤鍛?鍚嵂鍝併€佺敓鐗╁埗鍝併€佸尰鐤楀櫒姊扮瓑棰嗗煙)
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杩戞棩锛孎DA鍙戝竷浜?020骞村害缂洪櫡姹囨€绘姤鍛婏紝鍖呭惈鍖呮嫭鑽搧銆佺敓鐗╁埗鍝併€佸尰鐤楀櫒姊扮瓑棰嗗煙鍏?788鏉$己闄凤紝骞跺缂洪櫡鍙戠敓棰戠巼杩涜缁熻锛屽涓嬶細

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Cite Program Area Name寮曠敤鑼冨洿

483s Issued鍙戝竷鐨?83鏁?/span>

Biologics鐢熺墿鍒跺搧

28

Bioresearch Monitoring鐢熺墿鐮旂┒鐩戞祴

98

Devices鍖荤枟鍣ㄦ

422

Drugs鑽搧

349

Foods椋熷搧

1749

Human Tissue for Transplantation鐢ㄤ簬绉绘鐨勪汉浣撶粍缁?/span>

47

Parts 1240 and 1250

9

Radiologic Health鏀惧皠鍋ュ悍

9

Veterinary Medicine鍏借嵂

100

Sum Product Area 483s from System*鎬?83鏁?/span>

2811

Actual Total in System 483s**瀹為檯483鎬绘暟

2788

閮ㄥ垎缂洪櫡缈昏瘧濡備笅锛?/span>

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Long Description

缂洪櫡鎻忚堪

Frequency

棰戠巼

The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***[鏈缓绔嬩功闈㈢殑]閫傜敤浜庤川閲忔帶鍒跺崟浣嶇殑鑱岃矗鍜岀▼搴廩鎴栨湭瀹屽叏閬靛惊]銆傚叿浣撴潵璇达紝***

111

There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed. Specifically, ***鏈兘褰诲簳瀹℃煡[浠讳綍鏃犳硶瑙i噴鐨勫樊寮俔[涓€涓壒娆℃垨鍏朵换浣曠粍鍒嗘湭鑳芥弧瓒冲叾浠讳綍鏍囧噯]锛屾棤璁鸿鎵规槸鍚﹀凡缁忔斁琛屻€傚叿浣撴潵璇达紝***

79

Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. Specifically, ***QC鏈寘鎷缓绔嬬瀛﹀悎鐞嗗拰閫傚綋鐨刐瑙勮寖][鏍囧噯][鍙栨牱璁″垝][娴嬭瘯绋嬪簭]锛屼互纭繚[缁勫垎][鑽搧瀹瑰櫒][瀵嗗皝閮ㄤ欢][涓棿浜у搧][鏍囩][鑽墿鎴愬搧]绗﹀悎閫傚綋鐨勯壌瀹氥€佸惈閲忋€佽川閲忓拰绾害鏍囧噯銆傚叿浣撴潵璇达紝***

58

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Specifically, ***鏈缓绔嬩功闈㈢殑鐢熶骇鍜岃繃绋嬫帶鍒剁▼搴忥紝浠ョ‘淇濊嵂鐗╀骇鍝佸叿鏈夊叾澹扮О鐨勯壌瀹氥€佸惈閲忋€佽川閲忓拰绾害銆傚叿浣撴潵璇达紝***

46

Equipment used in the manufacture, processing, packing or holding of drug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance]. Specifically, ***鐢ㄤ簬鑽搧鐢熶骇銆佸姞宸ャ€佸寘瑁呮垨淇濆瓨鐨勮澶囨湭鑳絒閫傚綋璁捐][閫傚綋灏哄][閫傚綋浣嶇疆]锛屼互杩愯[绗﹀悎鍏堕鏈熺敤閫擼[閫傚悎娓呮磥鍜岀淮鎶鐨勬搷浣溿€?nbsp;鍏蜂綋鏉ヨ锛?**

44

Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product. Specifically, ***璁惧鍜岀敤鍏锋湭鑳戒互閫傚綋鐨勯棿闅擺娓呮磥][缁存姢][娑堟瘨]锛屼互闃叉[鏁呴殰][姹℃煋]鏀瑰彉鑽搧鐨勫畨鍏ㄣ€侀壌瀹氥€佸惈閲忋€佽川閲忔垨绾害銆?nbsp;鍏蜂綋鏉ヨ锛?**

42

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Specifically, ***鏈璁$畻鏈烘垨鐩稿叧绯荤粺瀹炴柦閫傚綋鐨勬帶鍒讹紝浠ョ‘淇濅富鐢熶骇鍜屾帶鍒惰褰曟垨鍏朵粬璁板綍鐨勬洿鏀逛粎鐢辨巿鏉冧汉鍛樿繘琛屻€?nbsp;鍏蜂綋鏉ヨ锛?**

38

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, ***鐢ㄤ互闃叉鏃犺弻鑽搧寰敓鐗╂薄鏌撶殑绋嬪簭鏈兘[寤虹珛][涔﹂潰][閬靛惊]銆傚叿浣撴潵璇达紝***

31

Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, ***鏈兘[閬靛惊]鏃㈠畾鐨刐瑙勮寖][鏍囧噯][鍙栨牱璁″垝][娴嬭瘯绋嬪簭][瀹為獙瀹ゆ帶鍒剁▼搴廬锛孾鎴栧湪鎵ц鏃惰褰昡銆?nbsp;鍏蜂綋鏉ヨ锛?**

31

Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, ***鏈兘鎸夌収涔﹂潰鐨勭▼搴忚繘琛孾鑷姩鍖朷 [鏈烘] [鐢靛瓙] 璁惧鐨勬棩甯竅鏍″噯] [妫€鏌 [妫€鏌浠ョ‘淇濇纭殑鎬ц兘 銆傚叿浣撴潵璇达紝***

29

Written records of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications] do not [always] include the conclusions and follow-up. Specifically, ***瀵逛簬[鏃犳硶瑙i噴鐨勫樊寮俔[涓€鎵规垨鍏朵换浣曠粍鍒嗕笉绗﹀悎鏍囧噯]鐨勪功闈㈣皟鏌ヨ褰曟湭鑳絒濮嬬粓]鍖呮嫭缁撹鍜屽悗缁帾鏂姐€傚叿浣撴潵璇达紝***

28

Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. Specifically, ***鍦ㄨ嵂鍝佺殑鍒堕€犮€佸姞宸ャ€佸寘瑁呮垨鍌ㄥ瓨杩囩▼涓紝鏈兘[鍒跺畾][閬靛惊]鐢ㄤ簬璁惧锛堝寘鎷櫒鍏凤級娓呮磥鍜岀淮鎶ょ殑涔﹂潰绋嬪簭銆傚叿浣撴潵璇达紝***

26

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release. Specifically, ***鐢ㄤ簬閿€鍞殑鑽搧鐨勬楠屽拰鏀捐鏈兘鍦ㄦ斁琛屽墠杩涜閫傚綋鐨勫疄楠屽妫€鏌ヤ互纭畾绗﹀悎[鏈€缁堟爣鍑哴[姣忕娲绘€ф垚鍒嗙殑閴村畾鍜屽惈閲廬銆傚叿浣撴潵璇达紝***

22

Control procedures are not established which [monitor the output] [validate the performance] of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Specifically, ***鏈兘寤虹珛鐢ㄤ互[鐩戞祴][楠岃瘉]鍙兘瀵艰嚧涓棿鐗╂枡鍜岃嵂鐗╀骇鍝佺壒鎬у彉寮傜殑宸ヨ壓鎬ц兘鐨勬帶鍒剁▼搴忋€傚叿浣撴潵璇达紝***

22

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, ***鏃犺弻鍔犲伐鍖哄湪鐜鏉′欢鐩戞祴绯荤粺鏂归潰瀛樺湪缂洪櫡銆傚叿浣撴潵璇达紝***

19

Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations]. Specifically, ***鍛樺伐鏈兘鎺ュ彈[鍏舵墍鎵ц鐨勭壒瀹氭搷浣淽[鐜拌GMP][鐜拌GMP鎵€瑕佹眰鐨勪功闈㈢▼搴廬鐨勫煿璁€傚叿浣撴潵璇达紝***

18

There is no written testing program designed to assess the stability characteristics of drug products. Specifically, ***鏈兘寤虹珛鐢ㄤ互璇勪和鑽墿浜у搧鐨勭ǔ瀹氭€х殑涔﹂潰娴嬭瘯绋嬪簭銆傚叿浣撴潵璇达紝***

18

Batch production and control records [are not prepared for each batch of drug product produced] [do not include complete information relating to the production and control of each batch]. Specifically, ***[鏈兘涓烘瘡鎵硅嵂鍝佺敓浜у噯澶嘳鎵圭敓浜у拰鎺у埗璁板綍[鏈兘鍖呮嫭涓庢瘡鎵硅嵂鍝佺敓浜у拰鎺у埗鏈夊叧鐨勫畬鏁翠俊鎭痌銆傚叿浣撴潵璇达紝***

16

The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in [manufacturing] [processing] [packing] [holding]. Specifically, ***鎵圭敓浜у拰鎺у埗璁板綍瀛樺湪缂洪櫡锛屽洜涓哄畠浠笉鍖呮嫭[鐢熶骇][鍔犲伐][鍖呰][淇濆瓨]涓瘡涓噸瑕佹楠ょ殑瀹屾垚璁板綍銆傚叿浣撴潵璇达紝***

16

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Specifically, , ***瀹為獙瀹よ褰曟湭鑳藉寘鎷敤浠ョ‘淇濈鍚堟棦瀹氳鑼冨拰鏍囧噯鐨勬墍鏈夋祴璇曘€佹鏌ュ拰鍒嗘瀽涓幏寰楃殑瀹屾暣鏁版嵁銆傚叿浣撴潵璇达紝锛?***

15

Employees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions. Specifically, ***浠庝簨鑽搧[鐢熶骇][鍔犲伐][鍖呰][淇濆瓨]鐨勫憳宸ョ己涔忓饱琛屽叾鎵€鍒嗛厤鑱岃兘鎵€闇€鐨刐鏁欒偛][鍩硅][缁忛獙]銆傚叿浣撴潵璇达紝***

14

The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented]. Specifically, ***鏈兘[寤虹珛][璁板綍]鍒嗘瀽鏂规硶鐨刐鍑嗙‘搴[鐏垫晱搴[涓撳睘鎬[鍙噸澶嶆€銆傚叿浣撴潵璇?/span>

14

There is no quality control unit. Specifically, ***娌℃湁璐ㄩ噺鎺у埗鍗曚綅銆傚叿浣撴潵璇达紝***

14

The written stability testing program is not followed. Specifically, ***鏈伒寰ǔ瀹氭€ф祴璇曠殑涔﹂潰绋嬪簭銆傚叿浣撴潵璇达紝***

13

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room] [equipment] to produce aseptic conditions. Specifically, ***鏃犺弻鍔犲伐鍖哄煙鍦╗鎴块棿][璁惧]娓呮磥鍜屾秷姣掍互浜х敓鏃犺弻鏉′欢鏂归潰瀛樺湪缂洪櫡銆傚叿浣撴潵璇达紝***

12

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include [adequate] validation of the [aseptic] [sterilization] process. Specifically, ***鐢ㄤ簬闃叉鏃犺弻鑽搧寰敓鐗╂薄鏌撶殑绋嬪簭鏈兘鍖呮嫭瀵筟鏃犺弻][鐏弻]宸ヨ壓鐨刐鍏呭垎]楠岃瘉銆傚叿浣撴潵璇达紝***

12

Written procedures are not [established] [followed] for evaluations done at least annually and including provisions for a review of [complaints] [recalls] [returned or salvaged drug products] [investigations conducted for each drug product]. Specifically, ***鏈兘[鍒跺畾][閬靛惊]涔﹂潰绋嬪簭浠ヨ嚦灏戞瘡骞磋繘琛岃瘎浠峰苟鍖呮嫭鍥為【[鎶曡瘔][鍙洖][閫€璐[瀵规瘡绉嶈嵂鍝佽繘琛岀殑璋冩煡]鐨勮瀹氥€傚叿浣撴潵璇达紝***

12

The quality control unit lacks authority to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred]. Specifically, ***璐ㄩ噺鎺у埗閮ㄩ棬缂轰箯鏉冨姏[瀹℃煡鐢熶骇璁板綍锛屼互纭繚娌℃湁鍙戠敓閿欒][鍏ㄩ潰璋冩煡宸插彂鐢熺殑閿欒]銆傚叿浣撴潵璇达紝***

11

Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance]. Specifically, ***[鍦ㄦ墽琛岀敓浜у拰杩囩▼鎺у埗鏃舵湭鑳介伒寰猐涔﹂潰鐨勭敓浜у拰杩囩▼鎺у埗绋嬪簭鎴朳鏈兘鎵ц鏃惰褰昡銆傚叿浣撴潵璇达紝***

11

Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair. Specifically, ***鐢ㄤ簬[鍒堕€燷[鍔犲伐][鍖呰][淇濆瓨]鑽搧鐨勫巶鎴挎湭鑳戒繚鎸佽壇濂界殑缁翠慨鐘舵€併€傚叿浣撴潵璇达紝***

11

Deviations from written production and process control procedures are not [recorded] [justified]. Specifically, ***鏈兘[璁板綍]涓庝功闈㈢敓浜у拰杩囩▼鎺у埗绋嬪簭鐨勭浉鍏崇殑鍋忓樊[鎴栦笉鍚堢悊]銆傚叿浣撴潵璇达紝***

11

Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without [performing at least one specific identity test on each component] [establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals]. Specifically, ***鍦ㄦ湭[瀵规瘡涓€涓師杈呮枡鑷冲皯鎵ц涓€涓壒瀹氱殑閴村畾娴嬭瘯][鍦ㄩ€傚綋鏃堕棿闂撮殧鍐呴€氳繃閫傚綋楠岃瘉渚涘簲鍟嗙殑娴嬭瘯缁撴灉纭畾渚涘簲鍟嗗垎鏋愮殑鍙潬鎬鐨勬儏鍐典笅锛屾帴鍙楁潵鑷師杈呮枡渚涘簲鍟嗙殑鍒嗘瀽鎶ュ憡锛岃€屾湭娴嬭瘯姣忎釜鍘熻緟鏂欐槸鍚︾鍚堟墍鏈夐€傚綋鐨勪功闈㈡爣鍑嗐€?nbsp;鍏蜂綋鏉ヨ锛?**

11

Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed]. Specifically, ***鏈兘[寤虹珛][涔﹂潰][閬靛惊]鐢ㄤ互闃叉闈炴棤鑿岃嵂鍝佹湁瀹冲井鐢熺墿鐨勭▼搴忋€?nbsp;鍏蜂綋鏉ヨ锛?**

10

Written records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, ***涓昏璁惧鐨勮澶囨棩蹇椾腑鏈兘鍖呮嫭[娓呮磥][缁存姢][浣跨敤]鐨勪功闈㈣褰曘€?nbsp;鍏蜂綋鏉ヨ锛?**

10

Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, ***瀹為獙瀹よ褰曟槸鏈夌己闄风殑锛屽洜涓哄畠浠湭鑳藉寘鎷湪娴嬭瘯杩囩▼涓幏寰楃殑鎵€鏈夋暟鎹殑瀹屾暣璁板綍銆傚叿浣撳湴璇?* * *

10

Written procedures are not [established] [followed] that describe the [in-process controls] [tests] [examinations] to be conducted on appropriate samples of in-process materials of each batch. Specifically, ***鏈兘[寤虹珛][閬靛惊]鎻忚堪瀵规瘡鎵逛腑闂翠骇鍝佺殑閫傚綋鏍峰搧杩涜[杩囩▼鎺у埗][娴嬭瘯][妫€鏌鐨勪功闈㈢▼搴忋€傚叿浣撴潵璇达紝***

10

Written records are not [always] made of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications]. Specifically, ***瀵筟鏃犳硶瑙i噴鐨勫樊寮俔[涓€涓壒娆℃垨鍏朵换浣曠粍鍒嗕笉绗﹀悎鏍囧噯]鐨勮皟鏌ユ病鏈変功闈㈣褰曘€傚叿浣撴潵璇达紝***

10

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. Specifically, ***鑽搧鏈兘寤虹珛鐢遍€傚綋绋冲畾鎬ф暟鎹‘瀹氱殑鏈夋晥鏈燂紝浠ョ‘淇濆畠浠湪浣跨敤鏃剁鍚堥€傚綋鐨勯壌瀹氥€佸惈閲忋€佽川閲忓拰绾害鏍囧噯銆?nbsp;鍏蜂綋鏉ヨ锛?**

9

Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, ***姣忔壒瑕佹眰涓嶅惈鏈夊寰敓鐗╃殑鑽搧鍧囨湭閫氳繃閫傚綋鐨勫疄楠屽娴嬭瘯杩涜妫€楠屻€傚叿浣撴潵璇达紝***

9

Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. Specifically, ***褰撶敤浜庤嵂鍝佺敓浜с€佸姞宸ャ€佸寘瑁呮垨淇濆瓨鏃讹紝鏈兘鎻愪緵閫傚綋鎺у埗[绌烘皵鍘嬪姏][寰敓鐗[鐏板皹][婀垮害][娓╁害]鐨勮澶囥€傚叿浣撴潵璇达紝***

9

Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed]. Specifically, ***鏈兘[寤虹珛][涔﹂潰][閬靛惊]鎻忚堪鑽搧鐨勬墍鏈変功闈㈠拰鍙eご鎶曡瘔鐨勫鐞嗙▼搴忋€?nbsp;鍏蜂綋鏉ヨ锛?**

9

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. Specifically, ***鏈瀹氭瘡涓敓浜ч樁娈靛畬鎴愮敓浜х殑鏃堕檺浠ョ‘淇濊嵂鐗╀骇鍝佽川閲忋€傚叿浣撴潵璇?/span>

8

Buildings used in the manufacture, processing, packing or holding of drug products are not [maintained in a clean and sanitary condition] [free of infestation by rodents, birds insects, and other vermin]. Specifically, ***鐢ㄤ簬鐢熶骇銆佸姞宸ャ€佸寘瑁呮垨淇濆瓨鑽搧鐨勫巶鎴挎湭鑳絒淇濇寔鍦ㄤ笉鍙楀暜榻垮姩鐗┿€侀笩绫汇€佹槅铏拰鍏朵粬铏渚垫壈鐨勬竻娲佸崼鐢熸潯浠禲銆傚叿浣撳湴璇?* * *

8

Changes to written procedures are not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, ***瀵逛功闈㈢▼搴忕殑鍙樻洿鏈猍缁忛€傚綋鐨勭粍缁囧崟浣嶈捣鑽夈€佸鏍稿拰鎵瑰噯][缁忚川閲忔帶鍒跺崟浣嶅鏍稿拰鎵瑰噯]銆傚叿浣撴潵璇达紝***

8

Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected. Specifically, ***鑽搧鏈繚瀛橀€傚綋鐨刐娓╁害][婀垮害][鍏夌収]鏉′欢涓嬶紝浣垮叾鐗规€с€佸己搴︺€佽川閲忓拰绾害涓嶅彈褰卞搷銆傚叿浣撳湴璇?* * *

8

Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed]. Specifically, ***涓荤敓浜у拰鎺у埗璁板綍缂轰箯[瀹屾暣鐨勭敓浜у拰鎺у埗璇存槑][鍙栨牱鍜屾祴璇曠▼搴廬[鏍囧噯][鐗规畩娉ㄩ噴][搴旈伒寰殑娉ㄦ剰浜嬮」]銆傚叿浣撴潵璇达紝***

8

GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them. Specifically, ***鏈兘[鎸佺画][浠ヨ冻澶熺殑棰戠巼]杩涜GMP 鍩硅浠ョ‘淇濆憳宸ュ閫傜敤浜庝粬浠殑 CGMP 瑕佹眰淇濇寔鐔熸倝銆傚叿浣撴潵璇达紝***

7

Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, ***鏈鏌?[璁$畻鏈篯 [鐩稿叧鍏紡绯荤粺] [璁板綍鎴栨暟鎹甝 鐨勮緭鍏ュ拰杈撳嚭鐨勫噯纭€с€傚叿浣撴潵璇达紝***

7

Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***缂轰箯涔﹂潰绋嬪簭鍏呭垎璇︾粏鎻忚堪[鍘熻緟鏂橾[瀹瑰櫒][瀵嗗皝閮ㄤ欢]鐨刐鎺ユ敹][閴村埆][鍌ㄥ瓨][澶勭悊][鎶芥牱][妫€楠宂[鎵瑰噯][鎷掔粷]銆傚叿浣撴潵璇达紝***

7

Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, ***鏈兘鎷掔粷涓嶇鍚堟棦瀹歔鏍囧噯][瑙勬牸][璐ㄩ噺鎺у埗鏍囧噯]鐨勮嵂鍝併€?nbsp;鍏蜂綋鏉ヨ锛?**

7

Written procedures for cleaning and maintenance fail to include [assignment of responsibility] [maintenance and cleaning schedules] [description in sufficient detail of methods, equipment and materials used] [description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or obliteration of previous batch identification] [instructions for protection of clean equipment from contamination prior to use] [parameters relevant to the operation]. Specifically, ***娓呮磥鍜岀淮鎶ょ殑涔﹂潰绋嬪簭娌℃湁鍖呮嫭[璐d换鍒嗛厤][缁存姢鍜屾竻娲佹椂闂磋〃][瀵逛娇鐢ㄧ殑鏂规硶銆佽澶囧拰鏉愭枡杩涜鍏呭垎璇︾粏鐨勮鏄嶿[鍏呭垎璇︾粏鎻忚堪蹇呰鐨勬媶瑙e拰閲嶆柊缁勮璁惧鐨勬柟娉曪紝浠ョ‘淇濋€傚綋鐨勬竻娲佸拰缁存姢][鍏充簬鎷嗛櫎鎴栨秷闄や互鍓嶆壒娆℃爣璇嗙殑璇存槑][浣跨敤鍓嶄繚鎶ゆ竻娲佽澶囧厤鍙楁薄鏌撶殑璇存槑][涓庢搷浣滄湁鍏崇殑鍙傛暟]銆傚叿浣撴潵璇达紝***

7

You used a non-pharmaceutical grade component in the formulation of a drug product. Specifically, ***锛?**鍦ㄨ嵂鍝侀厤鏂逛腑浣跨敤浜嗛潪鑽敤绾ф垚鍒嗐€傚叿浣撳湴璇达紝***

7

The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, ***銆愭墽琛屻€戙€愮洃鐫c€戣嵂鍝併€愮敓浜с€戙€愬姞宸ャ€戙€愬寘瑁呫€戙€愪繚瀛樸€戠殑鍚堟牸浜哄憳鏁伴噺涓嶈冻銆傚叿浣撳湴璇?* * *

6

Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, ***璁惧鐨勩€愮淮鎶ゃ€戙€愭竻娲椼€戙€愭秷姣掋€戙€愭鏌ャ€戞湭浣滆褰曘€傚叿浣撳湴璇?* * *

6

Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any of its specifications] did not extend to [other batches of the same drug product] [other drug products that may have been associated with the specific failure or discrepancy]. Specifically, ***瀵广€愪笉鏄庡師鍥犵殑宸紓銆戙€愭壒娆℃垨鍏朵换浣曟垚鍒嗕笉绗﹀悎鏍囧噯銆戠殑璋冩煡娌℃湁寤朵几鍒般€愬悓涓€鑽搧鐨勫叾浠栨壒娆°€戙€愬叾浠栧彲鑳戒笌鐗瑰畾鐨勪笉鍚堟牸鎴栧樊寮傛湁鍏崇殑鑽搧銆戙€傚叿浣撳湴璇?* * *

6

Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems. Specifically, ***鏈兘閫氳繃淇濈暀纭嫹璐濇垨澶囦唤绯荤粺鏉ヤ繚璇佸浠芥暟鎹殑[鍑嗙‘][瀹屾暣][瀹夊叏閬垮厤鏇存敼銆佸垹闄ゆ垨涓㈠け]銆傚叿浣撳湴璇?* * *

6

You produced hazardous drugs without providing adequate [containment] [segregation] [cleaning of work surfaces] [cleaning of utensils] [cleaning of personnel] to prevent cross-contamination. Specifically, ***浣犱滑鐢熶骇楂橀闄╄嵂鍝佹椂鏈兘鎻愪緵瓒冲鐨刐瀵嗛棴][闅旂][娓呮磥宸ヤ綔闈[娓呮磥鍣ㄧ毧][浜哄憳娓呮磥]浠ラ槻姝氦鍙夋薄鏌撱€傚叿浣撳湴璇?* * *

6

寰佺銆佽璋堛€佷笓棰樺悎浣滈偖浠?tougao@instrumentsinfo.com
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