中文字幕一级黄色A级片|免费特级毛片。性欧美日本|偷拍亚洲欧美1级片|成人黄色中文小说网|A级片视频在线观看|老司机网址在线观看|免费一级无码激情黄所|欧美三级片区精品网站999|日韩av超碰日本青青草成人|一区二区亚洲AV婷婷

10月18日，F(xiàn)DA在其官網(wǎng)發(fā)布了2021年缺陷匯總報告，其中包含F(xiàn)DA在2020年10月1日至2021年9月30日期間檢查的2430條檢查缺陷，其中藥品215條，醫(yī)療器械191條，生物制品17條。

 

 

藥品領(lǐng)域前十大缺陷如下：

 

1、"Theresponsibilities and procedures applicable to the quality control unit are not[in writing] [fully followed]. Specifically, ***

 

沒有[書面]的質(zhì)量控制單位的責(zé)任和程序或[沒有完全遵循]。"

 

檢查頻率：80

 

2、"There isa failure to thoroughly review [any unexplained discrepancy] [the failure of abatch or any of its components to meet any of its specifications] whether ornot the batch has been already distributed. Specifically, ***

 

未能徹底審查[任何無法解釋的差異][批次或其任何組分未能符合其任何標(biāo)準(zhǔn)]，無論該批次是否已經(jīng)放行。"

 

檢查頻率：49

 

3、"Thereare no written procedures for production and process controls designed toassure that the drug products have the identity, strength, quality, and puritythey purport or are represented to possess. Specifically, ***

 

沒有書面的生產(chǎn)和工藝控制程序，用以確保藥品具有其聲稱的鑒定、含量、質(zhì)量和純度。"

 

檢查頻率：44

 

4、"Laboratorycontrols do not include the establishment of scientifically sound andappropriate [specifications] [standards] [sampling plans] [test procedures]designed to assure that [components] [drug product containers] [closures][in-process materials] [labeling] [drug products] conform to appropriatestandards of identity, strength, quality and purity.  Specifically, ***

 

實驗室控制不包括建立科學(xué)合理和適當(dāng)?shù)腫標(biāo)準(zhǔn)][規(guī)范][取樣計劃][檢測程序]，旨在確保[部件][藥品容器][密封部件][中間產(chǎn)品][標(biāo)簽][成品]符合適當(dāng)?shù)蔫b定、含量、質(zhì)量和純度標(biāo)準(zhǔn)。"

 

檢查頻率：40

 

5、"Equipmentand utensils are not [cleaned] [maintained] [sanitized] at appropriateintervals to prevent [malfunctions] [contamination] that would alter thesafety, identity, strength, quality or purity of the drug product.  Specifically, ***

 

設(shè)備和器具未能在適當(dāng)?shù)拈g隔內(nèi)[清潔][維護][消毒]，以防止[故障][污染]改變藥品的安全性、鑒定、含量、質(zhì)量或純度。"

 

檢查頻率：33

 

6、"Appropriatecontrols are not exercised over computers or related systems to assure thatchanges in master production and control records or other records areinstituted only by authorized personnel. Specifically, ***

 

未能對計算機或相關(guān)系統(tǒng)進行適當(dāng)?shù)目刂?，以確保主生產(chǎn)和控制記錄或其他記錄的更改僅由授權(quán)人員進行。"

 

檢查頻率：30

 

7、"Equipmentused 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, ***

 

用于生產(chǎn)、加工、包裝或保存藥品的設(shè)備未能（設(shè)計適當(dāng)）[適當(dāng)尺寸][適當(dāng)安裝]，以適用其[預(yù)期用途][清潔和維護]的操作。"

 

檢查頻率：25

 

8、"Proceduresdesigned to prevent microbiological contamination of drug products purportingto be sterile are not [established] [written] [followed].  Specifically, ***

 

未能[建立][書面][遵循]用以防止無菌藥品的微生物污染的程序。"

 

檢查頻率：22

 

9、"Routine[calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performedaccording to a written program designed to assure proper performance.  Specifically, ***

 

未能按照用以確保適當(dāng)性能的書面程序?qū)自動][機械][電子]設(shè)備進行日常[校準(zhǔn)][檢查][核驗]。

 

檢查頻率：19

 

10、Employees arenot given training in [the particular operations they perform as part of theirfunction] [current good manufacturing practices] [written procedures requiredby current good manufacturing practice regulations].  Specifically, ***

 

員工未接受[他們作為職能的一部分執(zhí)行的特定操作][CGMP][CGMP要求的書面程序]的培訓(xùn)。

 

檢查頻率：18