GMP檢查期間發(fā)現(xiàn)的數(shù)據(jù)完整性和驗(yàn)證問題

1、GMP檢查期間發(fā)現(xiàn)的數(shù)據(jù)完整性和驗(yàn)證問題Data Integrity issues數(shù)據(jù)完整性問題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，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）來自灌裝線 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)線上灌裝的批次，也 沒有用以防止類似事件再次發(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