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

近日，F(xiàn)DA發(fā)布了對(duì)Dynamic Blending Specialists, Inc.的警告信，其中提及散裝單頁(yè)記錄沒(méi)有唯一標(biāo)識(shí)符、批記錄引用數(shù)據(jù)沒(méi)有保存、生產(chǎn)和倉(cāng)庫(kù)區(qū)域有碎紙箱、水監(jiān)測(cè)數(shù)據(jù)保存在個(gè)人電腦上等數(shù)據(jù)完整性缺陷：

Your scale calibration logs consisted of loose pages printed without unique identifiers.

你們的秤的校準(zhǔn)日志由打印的散裝頁(yè)組成，沒(méi)有唯一標(biāo)識(shí)符。

You could not provide a non-conformance (NC) report referenced      in (b)(4) executed batch records because your previous NC data system was no longer maintained.

無(wú)法提供已執(zhí)行批次記錄中引用的不合格（NC）報(bào)告，因以前的不合格數(shù)據(jù)系統(tǒng)已不再維護(hù)。

Shred bins containing what appeared to be CGMP records were      located in your manufacturing and warehouse areas.

生產(chǎn)和倉(cāng)庫(kù)區(qū)域有碎紙箱，其中包含疑似 CGMP 記錄。

Water monitoring records stored on an employee’s personal      computer could not be provided.

水監(jiān)測(cè)記錄存儲(chǔ)在員工個(gè)人電腦上，無(wú)法提供查閱。

You could not provide data to support the labeled expiration      date of drug products manufactured by your facility.

無(wú)法提供數(shù)據(jù)來(lái)支持所生產(chǎn)的藥品的有效期。

USP1029《良好文件記錄規(guī)范（Good Documentation Practice, GDocP）和數(shù)據(jù)完整性（Data Integrity, DI）》中提及多頁(yè)紙質(zhì)記錄（散裝單頁(yè)同理）的數(shù)據(jù)完整性控制要求：

All multiple-page data sheets or instrument printouts in paper form should be signed and/or initialed and dated on the first or last page with a note indicating the total number of pages. The first page and all subsequent pages should be uniquely identified as to the activity being performed, such as the notebook reference, study number, or worksheet reference.

所有多頁(yè)紙質(zhì)數(shù)據(jù)集或儀器打印輸出結(jié)果，應(yīng)在首頁(yè)或末頁(yè)簽名和 / 或草簽并注明日期，并標(biāo)注總頁(yè)數(shù)。首頁(yè)及后續(xù)所有頁(yè)面均應(yīng)唯一標(biāo)識(shí)所執(zhí)行的活動(dòng)，如筆記本編號(hào)、試驗(yàn)編號(hào)或工作記錄編號(hào)。