質(zhì)量風(fēng)險(xiǎn)管理進(jìn)展

質(zhì)量風(fēng)險(xiǎn)管理進(jìn)展主要內(nèi)容質(zhì)量風(fēng)險(xiǎn)管理進(jìn)展歐盟GMP對(duì)質(zhì)量風(fēng)險(xiǎn)管理要求現(xiàn)場(chǎng)檢查中對(duì)質(zhì)量風(fēng)險(xiǎn)管理要求質(zhì)量風(fēng)險(xiǎn)管理在我國(guó)制藥企業(yè)應(yīng)用現(xiàn)狀I(lǐng)CH《質(zhì)量風(fēng)險(xiǎn)管理》指南(Q9)發(fā)布后ICH為了貫徹Q8/Q9/Q10成立了質(zhì)量實(shí)施工作組,分別對(duì)在實(shí)施中的問(wèn)題進(jìn)行了解釋2009年3月2009年6月2009年10月2010年11月I簽C雷H乒《暫質(zhì)潮量犬風(fēng)哀險(xiǎn)睡管鎮(zhèn)理脫》慮指欲南剝(極Q滴9教)闖發(fā)參布?xì)Ш?妄0億1榆0挎年浴1逆月候4削日旺,陳P袋I缸C延/坑S社發(fā)疼布我了搜實(shí)尋施只質(zhì)窮量萬(wàn)風(fēng)踩險(xiǎn)旱管芝理倉(cāng)例啞子I鉆C訂H同《嬌質(zhì)曉量曠風(fēng)財(cái)險(xiǎn)自管助理懼》括指虎南籃(旬Q凈9嘉)令發(fā)餓布健后I貸S冒O況-掙3辭1鋤0滔0妹0客:艱《竹風(fēng)呆險(xiǎn)索管就理樣-含原鄰則時(shí)與糟指浙南褲》I誓S挎O質(zhì)/很I緣瑞E首C里-寨3長(zhǎng)1湖0辱1駐0啦:年《己風(fēng)籃險(xiǎn)域管滿理如-去風(fēng)腎險(xiǎn)務(wù)評(píng)泉估估技斧術(shù)掃》I考S掃O夠-蹦第買7可3蘋號(hào)匪指怕南師:遮《瀉風(fēng)盞險(xiǎn)慎管垃理志-揭術(shù)而語(yǔ)巴》I表C蟻H廉《巨質(zhì)他量混風(fēng)針險(xiǎn)憲管聞理嚷》注指黃南汪(陰Q叉9績(jī))彈發(fā)迅布黃后一偷些姿組傍織誰(shuí)也長(zhǎng)紛膀紛娛形器成切自劇己靜的歪指程南位性學(xué)文薄件P灶D烏A碼第寬4限4喝號(hào)側(cè)技海術(shù)牧報(bào)跌告薯:顆無(wú)拾菌料過(guò)殲程給質(zhì)絲式量攀風(fēng)架險(xiǎn)休管菊理I緒S綁P陪E必-享G寨A賭M神P布5黨:陰計(jì)泥算紫機(jī)次化修系雕統(tǒng)西基貨于形風(fēng)豎險(xiǎn)略方雄法膠與蜻G起X靈P訪符會(huì)合抗性I蔬S敲P礙E宵-允B攏A決S衡E霸L奮I乳N街E姿:千基健于炭風(fēng)駝險(xiǎn)店的乞藥弱品盒制仰造…藥蚊政雁部球門蟲行熊動(dòng)度:孤第殖一脫階沾段轉(zhuǎn)須化鑒I籮C兄H激《看質(zhì)更量茅風(fēng)兇險(xiǎn)住管父理凈》線指測(cè)南成兼本政地羞區(qū)修指晚南I塊C菠H溫《詳質(zhì)粉量迷風(fēng)莫險(xiǎn)半管勤理軌》拘指艙南刺(由Q猜9項(xiàng))碎轉(zhuǎn)枯化2或0惠0呢6肺年鞏1壺月甩,郵歐撥盟炮E娘M呀E爽A苗將宣I漁C叉H欣-億Q僅9座轉(zhuǎn)耐化助為貴官累方滲指稱南2側(cè)0僵0賽6姐年宵6席月血,納F藏D熱A閱將伐I核C棟H撐-浙Q滴9丟轉(zhuǎn)竹化怎為礦官埋方均指維南2享0枝0蜓6漁年衣9煮月情,棗日樣本靈官雀方桶將評(píng)I藥C痛H嫌-緩Q買9談轉(zhuǎn)俊化輔為祥日間文金指盲南指領(lǐng)南六階居段完舉成在負(fù)2晌0唇0細(xì)6姿年腰已言經(jīng)匪完匆成目蜘的將腐I龍C疼H塵《燭質(zhì)倡量立風(fēng)診險(xiǎn)洞管洪理平》殊指巨南蚊轉(zhuǎn)妥換語(yǔ)成塑本寨國(guó)哭/扒本給地中區(qū)灣指段南意勾義代摔表珍了訓(xùn)官走方孝對(duì)斧這早個(gè)碼問(wèn)存題建想獵法表鄭達(dá)愧了栽官乘方談對(duì)紀(jì)應(yīng)嘗用爐的麻希問(wèn)望藥荷政尸部府門須行始動(dòng)秩:陰第室二誼階清段融博入前I禾C宵H弓《困質(zhì)役量墓風(fēng)宜險(xiǎn)白管許理占》滿指忍南到每G涌M丘P出中歐燃盟蒜G叛M成P2奸0體0葵8敏年掀2叛月永,匠歐旁盟烘將罵I拍C伏H報(bào)-達(dá)Q傭9腿作見(jiàn)為端E葬U暫-溫G有M蹤蝶P口的妨第細(xì)2辜0螺附賊件揀收背錄辜到叨G柿M步P柏中2安0水0疤8笑年啟2疏月廣,植歐杜盟田修樂(lè)訂邊了餓E凍U苗-虎G襖M量P改第遣I互部應(yīng)分防第吊一龜章2碧0溉1憑0妻年炒2顫月止,唇2校0算0蘆8嫁年盤2寇月霜,期歐港盟嫩修出訂絨了蛙E慰U進(jìn)-畏G鋼M假P聲第避I斗I弟部立分剝第仿二歷章歐摔盟猶系價(jià)列員G當(dāng)M瓦PP暗I阿C胞/插S承-步G寧M屆PW缸H碎O困-法G姑M北P歐適盟少系尺列猾G謹(jǐn)M吊P罰在姜質(zhì)缺量挑風(fēng)滿險(xiǎn)械管版理怕要牽求云上糖保肥持珍高住度垂一嚼致似性歐搶盟滋系救列暢G重M碌P蛙對(duì)增質(zhì)食量李風(fēng)妹險(xiǎn)姜管畫理跡要采求原基界本湊結(jié)燦構(gòu)G矩M槍P明第螞I圣部盞分伶(辮制饞劑拆)捏/侄I怕I揚(yáng)部如分霧(青原槍料科藥蜻)質(zhì)澤量譯管怠理戒體誼系睬描鏡述捉中警進(jìn)食行敵要販求質(zhì)優(yōu)量航管虜理愉章除節(jié)曲增狠加曲質(zhì)凝量坐風(fēng)屑險(xiǎn)瓣管疤理約一殼章具置體低應(yīng)美用質(zhì)稻量薯管殘理溝體麗系鏟方港面鑄要遣求質(zhì)雨量尚管狀理畏-士基擔(dān)本竹原曉則…嗎要傳可戰(zhàn)靠護(hù)地雹達(dá)痰到麗這溝樣茶的婦質(zhì)話量傭目唉標(biāo)場(chǎng),腐必墨須來(lái)有焰一卸個(gè)鴿綜概合航設(shè)省計(jì)頌,左正旁確謊實(shí)矛施雹的動(dòng)體激系堆,婚整瓣合盡藥陰品銹生利產(chǎn)壓質(zhì)弦量歌管武理浸規(guī)封范廣,虧質(zhì)宴量元控型制衡,辨質(zhì)致量款保抓證勝體聞系掠與慨質(zhì)則量芳風(fēng)此險(xiǎn)扣管襯理質(zhì)料量程保畫證鹽,膜藥站品辨生撲產(chǎn)尖質(zhì)秋量扮管灰理洗規(guī)考范勤,渠質(zhì)支量悔控路制咐以侄及權(quán)質(zhì)忽量威風(fēng)客險(xiǎn)饅管港理冒的閱基絲式本樂(lè)概酸念單是局相謹(jǐn)互富關(guān)稠聯(lián)狹的質(zhì)夢(mèng)量禮風(fēng)形險(xiǎn)身管霉理飛是慘質(zhì)刃量股管建理山體哈系擔(dān)一影個(gè)醉組升成屯部漫分質(zhì)折量裝風(fēng)緊險(xiǎn)攝管岡理犬小休節(jié)熊要暗求質(zhì)六量瞧管慶理諸-裕質(zhì)娃量番風(fēng)肝險(xiǎn)倆管支理質(zhì)奔量閱風(fēng)逗險(xiǎn)憤管沃理為是糕一盞個(gè)簽用誤于感藥攤品羅質(zhì)武量備風(fēng)為險(xiǎn)揉評(píng)倒估潔,前控騙制陶,萬(wàn)交濾流倒與服審套核那的乒系舉統(tǒng)喇過(guò)閣程其咳可堡以歐前瀉瞻綁性卷或這回砌顧景性仇應(yīng)雜用質(zhì)華量槐風(fēng)柏險(xiǎn)亮管甩理丹定脈義膏以射及悶應(yīng)芳用迫方漸式質(zhì)冬量月風(fēng)擊險(xiǎn)扛管曬理礦小美節(jié)帥要膜求質(zhì)披量耐風(fēng)線險(xiǎn)零管緒理處系罪統(tǒng)迷應(yīng)偶當(dāng)腎保帆證協(xié)：基逼于供科醒學(xué)野知欲識(shí)商過(guò)浮程肌經(jīng)哄驗(yàn)繩評(píng)辨價(jià)丹質(zhì)否量場(chǎng)風(fēng)斷險(xiǎn)哈,黑并鋸最鮮終噸與已保穩(wěn)護(hù)散患字者炒相廉關(guān)延聯(lián)質(zhì)糞量莫風(fēng)晴險(xiǎn)神管秀理扁過(guò)谷程繼的可投設(shè)入績(jī),雞形采式冶與蹈文鈔件熱應(yīng)煤當(dāng)衫與陣風(fēng)磚險(xiǎn)睜水圣平嚷相張一季致質(zhì)喇量呀風(fēng)簽險(xiǎn)鞠管山理捆兩吵個(gè)托基側(cè)本暮原身則勉(躬I施C掉H亞-晃Q覽9好)質(zhì)閃量約風(fēng)霧險(xiǎn)窗管何理嘆小灣節(jié)熱要老求質(zhì)想量船風(fēng)果險(xiǎn)內(nèi)管步理堤的滲過(guò)獨(dú)程嶄與潔應(yīng)兆用米例爽子紡可櫻在術(shù)附額件飯2槳0堵中皺找寧到實(shí)慶施塊質(zhì)盜量炸風(fēng)春險(xiǎn)具管婚理尤總丘參頃考具納體俘應(yīng)卵用一藏般氣的除描樓述吵為斥:…安用姐質(zhì)丸量阻風(fēng)勸險(xiǎn)輔管芝理搏的鑰方小法嬌評(píng)玻估移…撫,燥以景保埋證舒…風(fēng)夕險(xiǎn)婚管失理伴應(yīng)肚當(dāng)誦應(yīng)攜用光于肚…作隔為偉風(fēng)討險(xiǎn)煎管榆理眾的憲一襯個(gè)煎部蘆分坊,錢…即應(yīng)潤(rùn)當(dāng)禾基撕于感…殿進(jìn)岡行偽風(fēng)呆險(xiǎn)圣評(píng)道估隨瓦著模G伶M援P癢各勢(shì)個(gè)蛇章返節(jié)澇不互斷撒修齒訂傾,闊這漸樣叉的姨句衫子磨越葵來(lái)扮越蔽多融給入辛G秧M桌P巖階耗段這姑個(gè)寺階砍段宇從勒2框0摧0盡8擇年普開(kāi)換始?xì)W望盟醋與姓P色I(xiàn)古C開(kāi)/鼓S質(zhì)旨量憑管招理魂體拔系做要各求參已律經(jīng)槐完關(guān)成質(zhì)炒量掌風(fēng)夫險(xiǎn)炮管纖理唱描囑述茄已每經(jīng)怪完半成個(gè)拳章憑節(jié)挺具初體酸要服求冊(cè)還插在槳進(jìn)咳行析中W歉H浸O含-鵲G廟M樸P正溉在吵做茄相趁關(guān)糞修丹訂藥延政臺(tái)部物門徒行演動(dòng)摸:然第赤三韻階鑼段對(duì)烏現(xiàn)別場(chǎng)每檢旬查瓦中存相胳應(yīng)典條遵款買進(jìn)勺行夏規(guī)郵范現(xiàn)胖場(chǎng)感檢逼查愈對(duì)哭質(zhì)鹽量介風(fēng)榆險(xiǎn)慚管么理晌要?jiǎng)?wù)求癥變咽化I則C泉H斜-柿Q千9雅剛瘦發(fā)狹布右后視,圣現(xiàn)耍場(chǎng)充檢育查蕩主疼要刃是是偵否攔有幅應(yīng)市用云愿低望是駝否楊有拴具催體爐應(yīng)職用在府E貴U裁-朝G兇M村P躍發(fā)首布捐相僑關(guān)剃要亭求蓋后是灑否聞體磁系染上天有猜相缸關(guān)肥規(guī)才定現(xiàn)索在隨統(tǒng)著犯檢談查蹄要魔求蹲的傍明緞確椅,惑質(zhì)豬量傷風(fēng)嚷險(xiǎn)梯管超理至作擁為吩質(zhì)游量堆管父理確的棚一壇個(gè)映要揚(yáng)素短來(lái)杯檢永查現(xiàn)喚場(chǎng)術(shù)檢稅查溫-搭首送先待要雕明燃確到關(guān)目撕前須為放止瞞,盛并惰沒(méi)疲有導(dǎo)專瓣門腔針懂對(duì)硬“年質(zhì)饅量旁風(fēng)牲險(xiǎn)規(guī)管納理恒”車認(rèn)況證慶或嗚專怠項(xiàng)乳檢攻查對(duì)捆“骨質(zhì)兇量思風(fēng)幅險(xiǎn)廳管謹(jǐn)理友”陪檢聞查反是命在販現(xiàn)塔場(chǎng)屯的廟“膏質(zhì)弓量潛體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hì)儉量湖管脾理涌體通系壞中管哈理祥職多責(zé)賤分餃配址表搭(仍管博理銷職姐責(zé)驕矩落陣嗓)質(zhì)賓量脫風(fēng)窯險(xiǎn)貢管丟理曬過(guò)眨程么控構(gòu)制有澡文且件壺描苦述易在朽質(zhì)采量淘風(fēng)芒險(xiǎn)撲系構(gòu)統(tǒng)寺下年,傍如喝何胞進(jìn)展行棋:辨死識(shí)餅風(fēng)鉆險(xiǎn)評(píng)沉估年風(fēng)殃險(xiǎn)控?fù)苤拼蒿L(fēng)潛險(xiǎn)溝銹通疑風(fēng)濁險(xiǎn)審領(lǐng)核叮風(fēng)致險(xiǎn)操曬作守層夢(mèng)面嫌文燦件標(biāo)游準(zhǔn)正操自作梢程關(guān)序滔(高S率O湯P像)斯整芹合拒到羊其連質(zhì)勻量胡體丈系確中規(guī)鄉(xiāng)豐定胖管世理涼系素統(tǒng)軌的嬸運(yùn)忍作計(jì)怪劃閣內(nèi)巨風(fēng)董險(xiǎn)洲評(píng)特估蓬的遮一盆般展的委方新法計(jì)賤劃盾外搏風(fēng)鑰險(xiǎn)宏評(píng)圓估鞠的仁一獻(xiàn)般牙的逆方漠法包泊括范獎(jiǎng)圍泡,勢(shì)職沃責(zé)雕,鏈控被制菌,獻(xiàn)批動(dòng)準(zhǔn)完,敬管筋理向系戒統(tǒng)痛,拒適喜應(yīng)跌性工,缺例夸外風(fēng)期險(xiǎn)蜘工原具放應(yīng)夫用繞總爸方概針書丹面更文元件課規(guī)污定淚在狀質(zhì)符量輕風(fēng)雞險(xiǎn)竹管奪理秀中燒應(yīng)皆用縮慧工聯(lián)具火的偉總瘦方腹針使倚用丈工高具枕范浴圍使盼用環(huán)工亂具串目奴的選謝擇鄰工賓具烤基拐本膚原造則使桑用剩工害具襯確勇認(rèn)質(zhì)腦量艇風(fēng)難險(xiǎn)裹管網(wǎng)理須在蓄中保國(guó)我江國(guó)緣瑞對(duì)寫質(zhì)陽(yáng)量徐風(fēng)乓險(xiǎn)些管美理黎要之求與離應(yīng)誰(shuí)用制現(xiàn)癥狀G首M到P獄(醒2痰0言1器0旗年辯修贈(zèng)訂否)熔對(duì)癥質(zhì)棕量煤風(fēng)別險(xiǎn)賽的斧描盤述晝(孔1戴)第修四斃節(jié)撲:串質(zhì)無(wú)量繼風(fēng)竊險(xiǎn)幕管迷理第攔十暑三搬條質(zhì)地量嫌風(fēng)砌險(xiǎn)劍管敬理亂是信在僵整價(jià)個(gè)痰產(chǎn)均品搬生蓮命謹(jǐn)周廈期雙中仇采除用攀前轎瞻欣或火回舒顧投的正方談式煌,替對(duì)壟質(zhì)赴量色風(fēng)皇險(xiǎn)綿進(jìn)尼行剝?cè)u(píng)早估押、友控會(huì)制輪、薯溝辟通短,稼審必核漫的況系間統(tǒng)搖過(guò)炭程應(yīng)算用陣期際間應(yīng)魯用屠方投式質(zhì)茂量浮風(fēng)股險(xiǎn)問(wèn)定竹義G始M蕩P煮(焰2賽0迎1事0亂年治修澆訂督)圣對(duì)把質(zhì)長(zhǎng)量乳風(fēng)澤險(xiǎn)躬的布描俊述感(益2省)第件四業(yè)節(jié)風(fēng):石質(zhì)澆量喚風(fēng)蹤蝶險(xiǎn)片管鳥(niǎo)理第竿十維四飽條應(yīng)如當(dāng)玩根弦據(jù)敲科替學(xué)煉知異識(shí)境及蔥經(jīng)抹驗(yàn)蘿對(duì)謊質(zhì)認(rèn)量老風(fēng)諷險(xiǎn)桐進(jìn)輝行造評(píng)扶估匙,偷以浮保典證面產(chǎn)況品野質(zhì)機(jī)量質(zhì)允量卷風(fēng)捆險(xiǎn)眨評(píng)促估盯基柱礎(chǔ)質(zhì)寬量腸風(fēng)委