GMP檢查期間發(fā)現(xiàn)的數(shù)據(jù)完整性和驗(yàn)證問(wèn)題_第1頁(yè)
GMP檢查期間發(fā)現(xiàn)的數(shù)據(jù)完整性和驗(yàn)證問(wèn)題_第2頁(yè)
GMP檢查期間發(fā)現(xiàn)的數(shù)據(jù)完整性和驗(yàn)證問(wèn)題_第3頁(yè)
GMP檢查期間發(fā)現(xiàn)的數(shù)據(jù)完整性和驗(yàn)證問(wèn)題_第4頁(yè)
GMP檢查期間發(fā)現(xiàn)的數(shù)據(jù)完整性和驗(yàn)證問(wèn)題_第5頁(yè)
已閱讀5頁(yè),還剩1頁(yè)未讀, 繼續(xù)免費(fèi)閱讀

下載本文檔

版權(quán)說(shuō)明:本文檔由用戶(hù)提供并上傳,收益歸屬內(nèi)容提供方,若內(nèi)容存在侵權(quán),請(qǐng)進(jìn)行舉報(bào)或認(rèn)領(lǐng)

文檔簡(jiǎn)介

1、GMP檢查期間發(fā)現(xiàn)的數(shù)據(jù)完整性和驗(yàn)證問(wèn)題Data Integrity issues數(shù)據(jù)完整性問(wèn)題The FDAinspectors found discrepancies between HMI (human machine interface) data and batch records and practices of operators not following batch instructions. Therefore the agency requires to provideFDA檢驗(yàn)員發(fā)現(xiàn)HMI (人機(jī)界面)數(shù)據(jù)與批記錄數(shù)據(jù)存 在差異,并且操作人員未按批指令操作。因此, FD

2、A要求提供:a comprehensive investigation into the extent of the inaccuracies in data records and reporting;全面調(diào)查數(shù)據(jù)記錄和報(bào)告不準(zhǔn)確的程度results of the data review for drugs distributed together with a detailed description of the scope and root causes of the data integrity lapses.已放行藥品的數(shù)據(jù)審核結(jié)果,以及數(shù)據(jù)完整性失效的范 圍和根本原因的詳細(xì)描述。

3、Validation issues驗(yàn)證問(wèn)題The agency observed a lack of process validationand, in addition, a lengthy bulk hold time prior tofilling drug products without assuring that this practice does not impact the chemical and microbiological quality.該機(jī)構(gòu)注意到未執(zhí)行工藝驗(yàn)證,止匕外,漫長(zhǎng)的待灌裝產(chǎn) 品保持時(shí)間未能確保這種做法不會(huì)影響化學(xué)和微生物質(zhì)量。The agency th

4、erefore requests因此,該機(jī)構(gòu)要求:a detailed summary of the validation program forensuring a state of control throughout the product lifecycle,用以確保在整個(gè)產(chǎn)品生命周期中處于受控狀態(tài)的驗(yàn)證計(jì)劃的詳細(xì)摘要,associatedproceduresincludingprocessperformance protocol(s), and written procedures (anda program) for qualification of equipment and f

5、acilities;相關(guān)程序,包括工藝性能方案,以及設(shè)備和設(shè)施確認(rèn)的書(shū)面程序(和計(jì)劃)a detailed program for designing, validating,maintaining,controllingand monitoringofmanufacturing processes that includes monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control.生產(chǎn)工藝設(shè)計(jì)、驗(yàn)證、維護(hù)、控制和監(jiān)測(cè)的詳細(xì)程序, 包括監(jiān)測(cè)批次內(nèi)和批次間變異,以確保持續(xù)受

6、控狀態(tài)。Particles and OOS Results粒子(異物)和OOS吉果According to FDA, the company failed to adequately investigate and document the presence of particles ina product. The manufacturer concluded that the particles were from a broken belt on the filling line, and the corrective action (CA) was to reject a number

7、 of units of this lot. However, this CA did not expandto cover batches that were previously filled at the same line or a preventative maintenance plan to prevent recurrence of similar incidents. In addition, the company failed to conduct an adequate investigation into an OOS test result for content.

8、 The FDA therefore requests to provide據(jù)FDA稱(chēng),該公司未能充分調(diào)查和記錄產(chǎn)品中是否存在 顆粒(異物)。制造商得由結(jié)論,顆粒(異物)來(lái)自灌裝線(xiàn) 上斷裂的傳送帶,糾正措施(CA)是拒絕此批次產(chǎn)品。但是,此CA未擴(kuò)展到涵蓋以前在該生產(chǎn)線(xiàn)上灌裝的批次,也 沒(méi)有用以防止類(lèi)似事件再次發(fā)生的預(yù)防性維護(hù)計(jì)劃。止匕外, 該公司沒(méi)有對(duì)OOSM試結(jié)果進(jìn)行充分調(diào)查。因此,F(xiàn)DA要求提供a comprehensive, independent assessment of the overall system for investigating deviations, discrepancies, complaints, OOS results, and failures,對(duì)偏差、差異、投訴、OOS和不合格結(jié)果調(diào)查的整個(gè)系統(tǒng)進(jìn)行全面、獨(dú)立的評(píng)估,an independent assessment and remediation plan for the CAPA program,對(duì)CAPA序進(jìn)行獨(dú)立評(píng)估和補(bǔ)救計(jì)劃,a comprehensive assessment and remediation pla

溫馨提示

  • 1. 本站所有資源如無(wú)特殊說(shuō)明,都需要本地電腦安裝OFFICE2007和PDF閱讀器。圖紙軟件為CAD,CAXA,PROE,UG,SolidWorks等.壓縮文件請(qǐng)下載最新的WinRAR軟件解壓。
  • 2. 本站的文檔不包含任何第三方提供的附件圖紙等,如果需要附件,請(qǐng)聯(lián)系上傳者。文件的所有權(quán)益歸上傳用戶(hù)所有。
  • 3. 本站RAR壓縮包中若帶圖紙,網(wǎng)頁(yè)內(nèi)容里面會(huì)有圖紙預(yù)覽,若沒(méi)有圖紙預(yù)覽就沒(méi)有圖紙。
  • 4. 未經(jīng)權(quán)益所有人同意不得將文件中的內(nèi)容挪作商業(yè)或盈利用途。
  • 5. 人人文庫(kù)網(wǎng)僅提供信息存儲(chǔ)空間,僅對(duì)用戶(hù)上傳內(nèi)容的表現(xiàn)方式做保護(hù)處理,對(duì)用戶(hù)上傳分享的文檔內(nèi)容本身不做任何修改或編輯,并不能對(duì)任何下載內(nèi)容負(fù)責(zé)。
  • 6. 下載文件中如有侵權(quán)或不適當(dāng)內(nèi)容,請(qǐng)與我們聯(lián)系,我們立即糾正。
  • 7. 本站不保證下載資源的準(zhǔn)確性、安全性和完整性, 同時(shí)也不承擔(dān)用戶(hù)因使用這些下載資源對(duì)自己和他人造成任何形式的傷害或損失。

評(píng)論

0/150

提交評(píng)論