目錄1、product['prɑd?kt] 92、process[pro?s?s;(forn.)?prɑs?s] 103、manufacture['m?nj?'f?kt??] 104、quality['kwɑl?ti] 115、material[m?'t?r??l] 126、medicinal[m?'d?s?n?l] 127、test[t?st] 138、batch[b?t?] 139、control[k?n'trol] 1410、record[(forv.)r??k?rd;(forn.)?rek?rd] 1511、system['s?st?m] 1512、appropriate[??propr??t;(forv.)??propr?et] 1613、sample['s?mpl] 1614、drug[dr?g] 1615、equipment[?'kw?pm?nt] 1716、procedure[pr?'sid??] 1717、container[k?n'ten?] 1818、package['p?k?d?] 1819、requirement[r?'kwa??m?nt] 1920、area['?r??] 1921、risk[r?sk] 2022、directive[da?'r?kt?v] 2023、operation[,ɑp?'re??n] 2124、contamination[k?n,t?m?'ne???n] 2225、part[pɑrt] 2226、label[?leb?l] 2327、validation[,v?l?'de??n] 2328、cell[s?l] 2429、person['p?sn] 2430、ensure[?n'??r] 2531、release[r?'lis] 2532、specification['sp?s?f?'ke??n] 2533、condition[k?n'd???n] 2634、follow['fɑlo] 2635、storage['st?r?d?] 2636、provide[pr?'va?d] 2737、take[tek] 2738、relevant['r?l?v?nt] 2739、annex[??n?ks;??n?ks;(forn.)??n??ks] 2840、fill[f?l] 2841、market['mɑrk?t] 2942、perform[p?'f?rm] 2943、define[d?'fa?n] 2944、number['n?mb?] 3045、monitor['m?n?t?] 3046、component[k?m'pon?nt] 3147、design[d?'za?n] 3148、write[ra?t] 3249、change[t?end?] 3250、finish['f?n??] 3351、reference['r?fr?ns] 3352、substance['s?bst?ns] 3453、authorisation[,?:θ?ra?'ze???n] 3455、data['det?] 3556、accordance[?'k?rdns] 3657、principle['pr?ns?pl] 3658、chapter['t??pt?] 3659、maintain[men'ten] 3660、date[det] 3761、measure['m???] 3862、establish[??st?bl??] 3863、biology[ba?'ɑl?d?i] 3964、practice['pr?kt?s] 3965、manage['m?n?d?] 4066、article['ɑrt?kl] 4167、active['?kt?v] 4168、site[sa?t] 4269、standard['st?nd?d] 4270、particular[p?'t?kj?l?] 4371、air[?r] 4372、apply[?'pla?] 4473、case[kes] 4474、trial['tra??l] 4575、check[t??k] 4576、available[??vel?b?l] 4677、different[?d?fr?nt] 4678、document[?dɑ:kjum?nt] 4679、environment[?n?va?r?nm?nt] 4780、base[bes] 4881、limit[?l?m?t] 4882、blood[bl?d] 4983、describe[d??skra?b] 4984、consist[k?n?s?st] 5085、place[ples] 5086、little['l?tl] 5187、subject[?s?bd??kt;(foradj.)?s?bd??kt;(forv.)s?b?d??kt] 5188、clean[klin] 5289、information['?nf?'me??n] 5390、section['s?k??n] 5491、approve[?'pr?v] 5492、facility[f?'s?l?ti] 5493、prevent[pri'v?nt] 5594、guide[ga?d] 5595、electronic[??l?k?trɑn?k] 5696、source[s?rs] 5697、unit['jun?t] 5798、method['m?θ?d] 5899、gas[g?s] 58100、sterile['st?r?l] 59101、order['?rd?] 60102、organism['?rɡ?n?z?m] 60103、stability[st?'b?l?ti] 61104、investigation[?n,v?st?'ɡe??n] 61105、review[r?'vju] 62106、code[kod] 62107、plasma['pl?zm?] 63108、handle['h?ndl] 63109、responsible[r?'spɑns?bl] 64110、transfer[tr?ns'f?] 64111、veterinary['v?t?r?n?ri] 65112、qualify[?kwɑl??fa?] 65113、retention[r?'t?n??n] 66114、stage[sted?] 66115、grade[ɡred] 67116、type[ta?p] 67117、identify[a?'d?nt?fa?] 68118、intend[?n't?nd] 68119、lot[lɑt] 69120、action['?k??n] 69121、certification[,s?t?f?'ke??n] 70122、commission[k?'m???n] 70123、step[st?p] 71124、compliance[k?m'pla??ns] 71125、cross[kr?s] 72126、possible['pɑs?bl] 72127、adequate[??d?kw?t] 73128、plant[pl?nt] 73129、cylinder[?s?l?nd?] 74130、level[?l?v?l] 74131、signature[?s?gn?t??] 74132、agent[?ed??nt] 75133、involve[?n?vɑ:lv] 75134、report[r??p?:rt] 76135、instruction[?n?str?k??n] 76136、justify[?d??st??fa?] 77137、laboratory[?l?br?t?:ri] 77138、period[?p?ri?d] 77139、closure[?klo???(r)] 78140、train[tren] 78141、determine[d??t?:rm?n] 79142、clinical[?kl?n?k?l] 79143、mean[min] 80144、assessment[??s?sm?nt] 80145、clear[kl?r] 81146、premise[?prem?s] 81147、regulation[?r?ɡj??le??n] 82148、set[s?t] 82149、distribution[?d?str??bju??n] 83150、retain[r??ten] 83151、account[??ka?nt] 84152、meet[mit] 84153、pharmaceutical[?fɑ:rm??su:t?kl] 84154、herbal[??:rbl] 85155、individual[??nd??v?d?u?l] 85156、preparation[?pr?p??re??n] 86157、assure[????r] 86158、criteria[kra??t?r??] 86159、critical[?kr?t?k?l] 87160、pressure[?pr???] 87161、competent[?kɑ:mp?t?nt] 88162、size[sa?z] 88163、supplier[s??pla??r] 89164、volume[?vɑ:lju:m] 89165、state[stet] 90166、amend[??m?nd] 90167、programme[?pro?ɡr?m] 91168、consideration[k?n?s?d??re??n] 91169、deviation[?divi?e??n] 92170、vessel['v?sl] 92171、parameter[p?'r?m?t?] 93172、intermediate[,?nt?'mid??t] 93173、sufficient[s??f???nt] 93174、separate[(forv.)s?p??ret;(foradj.)s?pr?t] 94175、purpose['p?p?s] 95176、fraction['fr?k??n] 95177、tissue['t??u] 96178、recall['rik?l] 96179、final['fa?nl] 97180、acceptance[?k's?pt?ns] 97181、media['mi?d??] 98182、cryogenic[,kra??'d??n?k] 98183、detail[d??tel] 99184、prior['pra??] 99185、status[?stet?s] 100186、technical['t?kn?kl] 100187、temperature[?temp?rt???r;t?mp?-?t??r] 101188、collection[k?'l?k??n] 102189、inspection[?n'sp?k??n] 102190、line[la?n] 102191、obtain[?b'ten] 103192、study['st?di] 103193、affect[?'f?kt] 104194、evaluation[?,v?lj?'e??n] 105195、example[?g'z?mpl] 105196、return[r?'t?n] 105197、significant[s?ɡ'n?f?k?nt] 106198、suitable[?sud?b(?)l] 106199、trace[tres] 107200、concern[k?n's?n] 107201、culture['k?lt??] 108202、primary['pra?m?ri] 108203、regard[r?'ɡɑrd] 109204、sponsor['spɑns?] 109205、additional[?'d???nl] 109206、aseptic[,e's?pt?k] 110207、audit['?d?t] 111208、conduct[k?n'd?kt] 111209、filter['f?lt?] 112210、mix[m?ks] 112211、normal['n?rml] 113212、radiopharmaceutical[,redio,fɑrm?'s?t?k?l] 113213、approach[?'prot?] 114214、avoid[?'v??d] 114215、confirm[k?n'f?m] 114216、contract['kɑntr?kt] 115217、derived[d?'ra?v] 115218、modify['mɑd?fa?] 116219、bank[b??k] 116220、content['kɑnt?nt] 116221、equivalent[?'kw?v?l?nt] 117222、health[h?lθ] 117223、quantity['kwɑnt?ti] 118224、room[rum] 118225、organize['?rg?,na?z] 119226、result[r?'z?lt] 119227、agree[?'ɡri] 120228、certain['s?tn] 120229、impact[?m'p?kt] 121230、indicate['?nd?ket] 121231、minimise['minimaiz] 122232、receive[r?'siv] 122233、reject[r?'d??kt] 122234、arrangement[?'rend?m?nt] 123235、complete[k?m'plit] 123236、correct[k?'r?kt] 123237、manner['m?n?] 124238、point[p??nt] 124239、expiry[?k'spa??ri] 125240、ingredient[?n'ɡrid??nt] 125241、defect[‘d?f?kt] 126242、integrity[?n't?ɡr?ti] 126243、water[?w?t?] 127244、dedicate['d?d?ket] 127245、hold[hold] 128246、adverse[?d?v?s,??d?v?s] 128247、virus['va?r?s] 129248、animal['?n?ml] 129249、safe[sef] 130250、dose[dos] 130251、bulk[b?lk] 131252、contact['kɑnt?kt] 131253、microbiological['ma?kroba?o'lɑd??kl] 131254、particle['pɑrt?kl] 132255、verification[,v?r?f?'ke??n] 132256、life[la?f] 133257、master['m?st?] 133258、present[pr??z?nt;(forn.)?pr?znt] 134259、protocol['prot?'k?l] 134260、radiation[,red?'e??n] 135261、remain[r?'men] 135262、continuous[k?n't?nj??s] 136263、supports?'p?rt] 136264、transport['tr?nsp?rt] 137265、valve[v?lv] 137266、analysis[?'n?l?s?s] 137267、development[d?'v?l?pm?nt] 138268、device[d?'va?s] 139269、initial[?'n???l] 139270、permit[p?'m?t] 139271、potential[p?'t?n?l] 140272、seal[sil] 140273、examination[?g'z?m?'ne??n] 141274、file[fa?l] 141275、nature['net??] 142276、plan[pl?n] 142277、address[??dr?s;(forn)??dres;?dr?s] 143278、associate[?'so??et] 143279、complaint[k?m'plent] 143280、live[la?v；l?v] 144281、routine[r?'tin] 144282、seed[sid] 145283、work[w?k] 145284、represent[,r?pr?'z?nt] 146285、cause[k?z] 147286、raw[r?] 147287、party['pɑrti] 147288、shelf[??lf] 148289、heat[hit] 148290、cycle['sa?kl] 149291、vector['v?kt?] 149292、quarantine['kw?r?n'tin] 149293、maximum[?m?ks?m?m] 150294、chemical['k?m?kl] 150295、stock[stɑk] 151296、purity['pj?r?ti] 151297、computerise[k?m'pju:t?raiz] 152298、trend[tr?nd] 152299、treatment['tritm?nt] 153300、spatial[?spe??l] 153301、department[d?'pɑrtm?nt] 154302、surface['s?f?s] 154303、physical['f?z?kl] 154304、load[lod] 155305、head[h?d] 155306、connection[k?'n?k??n] 156307、zone[zon] 156308、solution[s?'lu??n] 157309、failure[elj?] 158310、cloth[kl?θ] 158311、chain[t?en] 159312、attribute[?'tr?bjut] 159313、key[ki?] 159314、vial['va??l] 160315、reserve[r?'z?v] 160316、space[spes] 161317、particulate[p?'t?kj?,let] 161318、dry[dra?] 162319、visual['v????l] 162320、liquid['l?kw?d] 163321、indicator['?nd?ket?] 163322、freeze[friz] 164323、error['?r?] 164324、alternative[?l't?n?t?v] 165325、wash[w??] 165326、terminal[t?:m?nl] 166327、positive['pɑz?t?v] 166328、version['v??n] 167329、formulation[,f?rmj?'le??n] 167330、installation['?nst?'le??n] 168331、waste[west] 168332、reaction[r?'?k??n] 169333、bioburden[,ba???'b??d?n] 169334、humidity[hju'm?d?ti] 170335、extraction[?k'str?k??n] 1701、product['prɑd?kt]n.產(chǎn)品；成果；[數(shù)]乘積；作品production[pr?'d?k??n]n.成果；產(chǎn)品；生產(chǎn)；作品GMPappliestothelifecyclestagesfromthemanufactureofinvestigationalmedicinalproducts,technologytransfer,commercialmanufacturingthroughtoproductdiscontinuation.（歐盟GMP附錄第一章1.2）GMP的應(yīng)用貫穿于生產(chǎn)臨床研究用藥品、技術(shù)轉(zhuǎn)移、商業(yè)化生產(chǎn)直至產(chǎn)品退市的整個生命周期中。finishedproduct成品finalproduct最后產(chǎn)品bloodproduct血液制品productquality產(chǎn)品質(zhì)量productdefect產(chǎn)品缺點bulkproduct待包裝產(chǎn)品sterileproduct無菌產(chǎn)品productlabelling產(chǎn)品標簽medicinalproduct醫(yī)藥產(chǎn)品biologicalproduct生物制品aerosolproduct噴霧劑產(chǎn)品recalledproduct召回的產(chǎn)品marketedproduct上市的產(chǎn)品intermediateproduct中間產(chǎn)品productlifecycle產(chǎn)品生命周期non-sterilisedproduct非無菌產(chǎn)品ProductQualityReviews產(chǎn)品質(zhì)量回想ProductSpecificationFile產(chǎn)品規(guī)格文獻asepticallyfilledproduct過濾除菌灌裝產(chǎn)品terminallysterilisedproduct終端滅菌產(chǎn)品InvestigationalMedicinalProduct臨床實驗產(chǎn)品drugproduct成品（注射液、膠囊、藥片等）drugsubstance原料藥2、process[pro?s?s;(forn.)?prɑs?s]vt.解決；加工；n.過程，進行；辦法，環(huán)節(jié)；作用；程序；推移；vi.列隊邁進；adj.通過特殊加工（或解決）的Criticalstepsofmanufacturingprocessesandsignificantchangestotheprocessarevalidated。（歐盟GMP附錄1.8）生產(chǎn)工藝的核心環(huán)節(jié)以及重大工藝的變更已經(jīng)通過驗證。fillingprocess灌裝工藝in-processtest中控檢測cleaningprocess清潔工藝releaseprocess放行過程processvalidation工藝驗證processverification工藝確認in-processmaterial中間材料sterilisationprocess滅菌過程in-processcontrol中間過程控制continuousprocessverification持續(xù)工藝確認ongoingprocessverification持續(xù)工藝確認criticalprocessparameter核心工藝參數(shù)（CPP）3、manufacture['m?nj?'f?kt??]n.制造；產(chǎn)品；制造業(yè)；vt.制造；加工；捏造；vi.制造manufacturer[,m?nju'f?kt??r?]n.制造商；[經(jīng)]廠商Themanufactureofsterileproductsissubjecttospecialrequirementsinordertominimizerisksofmicrobiologicalcontamination,andofparticulateandpyrogencontamination.（歐盟GMP附錄1，原則）為了使微生物污染、懸浮粒子和熱源污染的風(fēng)險最小化，無菌藥品的制造應(yīng)受某些特殊規(guī)定的制約。Culturemediashouldbepreparedinaccordancewiththemediamanufacturer’srequirementsunlessscientificallyjustified.（歐盟GMP附錄6.23）培養(yǎng)基需要按照培養(yǎng)基供應(yīng)商的規(guī)定來制備，除非有科學(xué)的根據(jù)。routinemanufacture常規(guī)生產(chǎn)asepticmanufacture無菌生產(chǎn)campaignedmanufacture階段式生產(chǎn)authorisedmanufacturer經(jīng)授權(quán)的制造商4、quality['kwɑl?ti]n.質(zhì)量[統(tǒng)計]品質(zhì)；特性；才干；adj.優(yōu)質(zhì)的；高品質(zhì)的qualify[?kwɑl??fa?]vt.限制；使含有資格；證明…合格vi.獲得資格，有資格Qualityriskmanagementisasystematicprocessfortheassessment,control,communicationandreviewofriskstothequalityofthemedicinalproduct.（歐盟GMP1.12）質(zhì)量風(fēng)險管理是一種用于藥品質(zhì)量風(fēng)險評定、控制、交流與評審的系統(tǒng)過程。qualityunit質(zhì)量部qualitydefect質(zhì)量缺點qualityreview質(zhì)量回想qualitymanual質(zhì)量手冊qualityobjective質(zhì)量目的qualitycomplaint質(zhì)量投訴qualityofproduct產(chǎn)品質(zhì)量qualitycharacteristic質(zhì)量特性qualitycontrol質(zhì)量控制（QC）qualityassurance質(zhì)量確保（QA）qualitypolicy質(zhì)量政策；質(zhì)量方針QualifiedPerson質(zhì)量受權(quán)人（QP）qualifiedsupplierList合格供應(yīng)商清單qualitybydesign質(zhì)量源于設(shè)計（QbD）acceptablequalitylevel可接受質(zhì)量水平criticalqualityattribute核心質(zhì)量屬性（CQA）qualityriskmanagement質(zhì)量風(fēng)險管理（QRM）qualitymanagementsystem質(zhì)量管理體系（QMS）PharmaceuticalQualitySystem藥品質(zhì)量體系（PQS）5、material[m?'t?r??l]n.材料，原料；物資；布料；adj.重要的；物質(zhì)的，實質(zhì)性的；肉體的Samplesofstartingmaterials,packagingmaterials,intermediateproducts,bulkproductsandfinishedproductsaretakenbyapprovedpersonnelandmethods.（歐盟GMP1.9ii）有通過同意的人員按照通過同意的辦法對起始物料、包裝材料、中間產(chǎn)品、半成品和成品取樣。rawmaterial原料criticalmaterial核心物料labelingmaterial標簽材料startingmaterial起始物料noxiousmaterial有毒物質(zhì)incomingmaterial進廠物料in-processmaterial中間材料rejectedmaterial不合格物料packagingmaterial包裝材料compendialmaterial藥典規(guī)定的物料printedpackagingmaterial印刷包裝材料6、medicinal[m?'d?s?n?l]adj.藥的；藥用的；治療的（等于medicinable）；有益的medicine

[?med?sn;m?d?sn]n.藥；醫(yī)學(xué)；內(nèi)科；巫術(shù)vt.用藥品治療；給…用藥medical['m?d?kl]adj.醫(yī)學(xué)的；藥的；內(nèi)科的n.醫(yī)生；體格檢查APharmaceuticalQualitySystemappropriateforthemanufactureofmedicinalproductsshouldensurethat:（歐盟GMP1.4）一種適宜的藥品質(zhì)量體系應(yīng)確保一下方面：medicinalgases醫(yī)用氣體medicinalproduct醫(yī)藥產(chǎn)品biologicalmedicinalactivesubstance生物藥用活性物質(zhì)7、test[t?st]n.實驗；檢查；vt.實驗；測試；vi.實驗；測試retest[,ri't?st]n.再測驗；再考驗vt.再考驗；[實驗]重復(fù)測試OnlystartingmaterialswhichhavebeenreleasedbytheQualityControldepartmentandwhicharewithintheirretestperiodshouldbeused.（歐盟GMP5.34）其實物料只有通過QC檢測放行并且在有效復(fù)驗期內(nèi)再能使用。testitem檢測項目leaktest泄露測試testresult檢測成果sterilitytest無菌檢查identitytest鑒別測試testmethod檢測辦法in-linetesting在線測試testingreport檢測報告integritytest完整性測試testinginterval檢測間隔microbialtest微生物檢測black-boxtesting黑盒測試white-boxtesting白盒測試in-processtesting中控檢測bioburdentesting生物負載檢測siteacceptancetesting現(xiàn)場驗收測試（SAT）factoryacceptancetesting工廠驗收測試（FAT）8、batch[b?t?]n.一批；一爐；一次所制之量；vt.分批解決ABatchProcessingRecordshouldbekeptforeachbatchprocessed所生產(chǎn)的每一批產(chǎn)品都需要保存一份批生產(chǎn)統(tǒng)計。（歐盟GMP4.20）batchsize批量batchnumber批號batchrecord批統(tǒng)計batchrelease批放行batchcertificate批報告單masterbatchrecord主批統(tǒng)計batchdocumentation批文獻batchpackagingrecord批包裝統(tǒng)計batchprocessingrecord批生產(chǎn)統(tǒng)計batchproductionrecord批生產(chǎn)統(tǒng)計batchcertificationrecord批放行統(tǒng)計batchdistributionrecord批運輸統(tǒng)計9、control[k?n'trol]n.控制；管理；克制；操縱裝置；vt.控制；管理；克制Visitorsoruntrainedpersonnelshould,preferably,notbetakenintotheproductionandqualitycontrolareas.（歐盟GMP2.13）最佳不要把參觀者或未經(jīng)培訓(xùn)的人員帶入生產(chǎn)和質(zhì)量控制區(qū)域。pestcontrol蟲害控制on-linecontrol在線控制changecontrol變更控制controlstrategy控制方略controlmeasure控制方法In-processcontrol過程控制qualitycontrol質(zhì)量控制（QC）environmentalcontrol環(huán)境控制10、record[(forv.)r??k?rd;(forn.)?rek?rd]vt.統(tǒng)計，記載；標明；將...錄音；vi.統(tǒng)計；錄音；n.檔案，履歷；唱片；最高紀錄；adj.創(chuàng)紀錄的Peopleinresponsiblepositionsshouldhavespecificdutiesrecordedinwrittenjobdescriptionsandadequateauthoritytocarryouttheirresponsibilities.（歐盟GMP總則2.3）針對各崗位員工應(yīng)當(dāng)制訂崗位職責(zé)闡明書，在崗位職責(zé)闡明書中對工作的內(nèi)容進行書面的描述，并給員工充足的授權(quán)以推行職責(zé)。paperrecord紙質(zhì)統(tǒng)計trainingrecord培訓(xùn)統(tǒng)計electronicrecord電子統(tǒng)計sterilisationrecord滅菌統(tǒng)計batchprocessingrecord批生產(chǎn)統(tǒng)計batchpackagingrecord批包裝統(tǒng)計batchproductionrecord批生產(chǎn)統(tǒng)計batchcertificationrecord批放行統(tǒng)計batchdistributionrecord批運輸統(tǒng)計11、system['s?st?m]n.制度，體制；系統(tǒng)；辦法ThePharmaceuticalQualitySystemshouldbedefinedanddocumented.（歐盟GMP1.7）藥品質(zhì)量體系需要進行定義并文獻化。opensystem

開放系統(tǒng)closedsystem封閉系統(tǒng)computerisedsystem計算機化系統(tǒng)riskmanagementsystem風(fēng)險管理系統(tǒng)qualityassurance system質(zhì)量確保系統(tǒng)qualitymanagementsystem質(zhì)量管理體系（QMS）pharmaceuticalqualitysystem藥品質(zhì)量體系（PQS）LaboratoryInformationManagementSystem實驗室信息管理系統(tǒng)（LIMS）12、appropriate[??propr??t;(forv.)??propr?et]adj.適宜的；恰當(dāng)?shù)?；適宜的；vt.占用，撥出Documentscontaininginstructionsshouldbeapproved,signedanddatedbyappropriateandauthorisedpersons.（歐盟GMP4.3）含有操作闡明的文獻應(yīng)當(dāng)由通過授權(quán)的適宜人員同意、簽字并訂立日期。asappropriate酌情，視狀況而定whereappropriate在適宜的狀況下13、sample['s?mpl]vt.取樣；嘗試；抽樣檢查；n.樣品；樣本；例子；adj.試樣的，樣品的；作為例子的Arepresentativesampleofunitsshallbecollectedatthecompletionoffinishingoperationsandshallbevisuallyexaminedforcorrectlabeling.（21CFRPart211.134）操作結(jié)束時，每組收集一種代表性樣品，同時檢查標簽與否對的。reservesample留樣referencesample對照樣品samplecontainer樣品容器samplingmethod取樣辦法retentionsample存留樣品，留樣representativesample有代表性的樣品14、drug[dr?g]n.藥；毒品；麻醉藥；滯銷貨；vt.使服麻醉藥；使服毒品；摻麻醉藥于；vi.吸毒Closedsystem.Whereadrugsubstanceorproductisnotexposedtotheimmediateroomenvironmentduringmanufacture.（歐盟GMP附錄2術(shù)語）密閉系統(tǒng)：在生產(chǎn)過程中原料藥或產(chǎn)品不直接暴露到房間的環(huán)境中。drugsubstance原料藥investigationaldrug臨床實驗用藥品activedrugingredient活性藥品成分FoodandDrugAdministration食品藥品監(jiān)督管理局drugproduct藥品成品，能體現(xiàn)最后劑量的藥品，涉及藥片、膠囊和藥液等。15、equipment[?'kw?pm?nt]n.設(shè)備，裝備；器材equip

[?'kw?p]vt.裝備，配備Directcontactshouldbeavoidedbetweentheoperator’shandsandtheexposedproductaswellaswithanypartoftheequipmentthatcomesintocontactwiththeproducts.（歐盟GMP2.20）操作人員應(yīng)當(dāng)避免裸手直接接觸藥品以及與藥品直接接觸的設(shè)備表面。sealequipment密封設(shè)備fillingequipment灌裝設(shè)備ancillaryequipment輔助設(shè)備dedicatedequipment專用設(shè)備sterilizingequipment消毒設(shè)備qualifiedequipment合格的設(shè)備automatedequipment自動化設(shè)備manufacturingequipment生產(chǎn)設(shè)備premisesandequipment廠房設(shè)施與設(shè)備16、procedure[pr?'sid??]n.程序，手續(xù)；環(huán)節(jié)Thereshouldbewrittenproceduresandrecordsforthereceiptofeachdeliveryofeachstartingmaterial,(includingbulk,intermediateorfinishedgoods),primary,secondaryandprintedpackagingmaterials.（歐盟GMP4.22）應(yīng)當(dāng)有每一種起始物料（涉及半成品、中間體或成品）、內(nèi)包裝材料、外包裝材料和印字包材每次接受的書面規(guī)程和統(tǒng)計。writtenprocedure書面程序approvedprocedure同意的程序StandardOperatingProcedure原則操作程序（SOP）17、container[k?n'ten?]n.集裝箱；容器contain

[k?n'ten]vt.包含；控制；容納；牽制（敵軍）vi.含有；自制Containersforfillingshouldbecleanbeforefilling.（歐盟GMP5.53）用于灌裝的容器在灌裝之前需要進行清潔。filledcontainer灌裝容器finalcontainer最后容器samplecontainer樣品容器storagecontainer儲存容器sterilisedcontainer無菌容器drugproductcontainer藥品容器18、package['p?k?d?]n.包，包裹；套裝軟件，[計]程序包；adj.一攬子的；vt.打包；將…包裝repackage[ri'p?k?d?]vt.重新包裝；重新裝配pack[p?k]n.包裝；一群；背包；包裹；一副;vt.包裝；壓緊；捆扎；挑選；塞滿;vi.擠；包裝貨品；被包裝；群集Premisesforthepackagingofmedicinalproductsshouldbespecificallydesignedandlaidoutsoastoavoidmix-upsorcross-contamination.（歐盟GMP3.15）應(yīng)對藥品包裝廠房進行專門的設(shè)計不和布局，以避免混淆或交叉污染。marketedpackage上市包裝packagingmaterial包裝材料batchpackagingrecord批包裝統(tǒng)計printedpackagingmaterial印刷包裝材料primarypackagingmaterial初級包裝材料，內(nèi)包材19、requirement[r?'kwa??m?nt]n.規(guī)定；必要條件；必需品require[r?'kwa?r]vt.需要；規(guī)定；命令Specialrequirementsareneededinlaboratorieshandlingparticularsubstances,suchasbiologicalorradioactivesamples.（歐盟GMP3.29）在實驗室解決特殊物質(zhì)時應(yīng)能滿足特殊的規(guī)定，如生物或放射性樣品。establishedrequirement既定規(guī)定UserRequirementsSpecification顧客需求闡明（URS）20、area['?r??]n.區(qū)域，地區(qū)；面積；范疇Personnelworkinginareaswherecontaminationisahazard,e.g.cleanareasorareaswherehighlyactive,toxic,infectiousorsensitisingmaterialsarehandled,shouldbegivenspecifictraining.（歐盟GMP2.12）對于污染物是危險品的區(qū)域，例如解決高活性、高毒性、高傳染性或高致敏性物料的區(qū)域或干凈區(qū)等，在該區(qū)域工作的人員應(yīng)當(dāng)通過專門的培訓(xùn)。cleanarea干凈區(qū)storagearea存儲區(qū)separatearea隔離區(qū)receptionarea接受區(qū)highriskarea高風(fēng)險區(qū)productionarea生產(chǎn)區(qū)qualitycontrolarea質(zhì)量控制區(qū)separatesamplingarea單獨的取樣區(qū)controlled/notclassifiedarea受控但非干凈區(qū)21、risk[r?sk]n.風(fēng)險；危險；冒險；vt.冒…的危險In-processcontrolsmaybecarriedoutwithintheproductionareaprovidedtheydonotcarryanyrisktoproduction.（歐盟GMP3.17）在不給生產(chǎn)帶來任何風(fēng)險的狀況下，能夠在生產(chǎn)區(qū)域內(nèi)進行中間過程的控。riskreview風(fēng)險回想riskcontrol風(fēng)險控制riskanalysis風(fēng)險分析riskreduction風(fēng)險減少highriskarea高風(fēng)險區(qū)riskevaluation風(fēng)險評價potentialrisk潛在的風(fēng)險riskacceptance風(fēng)險接受riskassessment風(fēng)險評定riskidentification風(fēng)險識別riskcommunication風(fēng)險溝通highriskoperation高風(fēng)險的操作risk-reducingaction減少風(fēng)險的行動levelofrisk風(fēng)險的等級；風(fēng)險的水平QualityRiskManagement質(zhì)量風(fēng)險管理22、directive[da?'r?kt?v]n.批示；指令；adj.指導(dǎo)的；管理的direct[d??r?kt;da??r?kt]adj.直接的；直系的；親身的；正好的vt.管理；指揮；導(dǎo)演；指向vi.指導(dǎo)；指揮adv.直接地；正好；按直系關(guān)系direction[d??r?k??n;(also)da??r?k??n]n.方向；指導(dǎo)；趨勢；使用方法闡明Lighting,temperature,humidityandventilationshouldbeappropriateandsuchthattheydonotadverselyaffect,directlyorindirectly,eitherthemedicinalproductsduringtheirmanufactureandstorage,ortheaccuratefunctioningofequipment.（歐盟GMP3.3）廠房應(yīng)有適宜的照明、溫濕度與通風(fēng)，并確保在生產(chǎn)與儲存期間藥品質(zhì)量以及有關(guān)設(shè)備的精確性不直接或間接地受到不良的影響。axialdirection軸向radialdirection徑向verticaldirection垂直方向flowdirection流向；程序方向underthedirectionof在…的指導(dǎo)下oppositedirection相反方向；敵對方longitudinaldirection縱向流變；軸向winddirection風(fēng)向；風(fēng)向選擇；風(fēng)的角horizontaldirection水平方向；水平偏轉(zhuǎn)23、operation[,ɑp?'re??n]n.操作；經(jīng)營；[外科]手術(shù)；[數(shù)][計]運算operate['ɑp?'ret]vi.運轉(zhuǎn)；動手術(shù)；起作用vt.操作；經(jīng)營；引發(fā)；對…開刀operator['ɑp?ret?]n.經(jīng)營者；操作員；話務(wù)員；行家The“inoperation”and“atrest”statesshouldbedefinedforeachcleanroomorsuiteofcleanrooms.（歐盟GMP附錄I3）應(yīng)當(dāng)為每個干凈室或每套干凈室定義“靜態(tài)”和“動態(tài)”inoperation動態(tài)生產(chǎn)中fillingoperation灌裝操作recalloperation召回操作criticaloperation核心操作asepticoperation無菌操作cappingoperation壓蓋操作packagingoperation包裝操作operationalinstruction操作指令operationqualification運行確認（OQ）opencircuitoperation空載運行；開路運行24、contamination[k?n,t?m?'ne???n]n.污染，玷污；污染物contaminate[k?n't?m?net]vt.污染，弄臟decontaminate['dik?n't?m?'net]vt.凈化，給…去污contaminant[k?n't?m?n?nt]n.污染物；致污物Cross-contaminationshouldbepreventedforallproductsbyappropriatedesignandoperationofmanufacturingfacilities.（歐盟GMP3.6）全部產(chǎn)品都需要通過合理的設(shè)計和運行生產(chǎn)設(shè)施來避免交叉污染。cross-contamination交叉污染aerialcontamination空氣污染particulatecontamination粒子污染microbialcontamination微生物污染environmentalcontamination環(huán)境污染microbiologicalcontamination微生物污染25、part[pɑrt]n.部分；角色；零件；某些；片段；vt.分離；分派；分開；vi.斷裂；分手；adv.部分地；adj.部分的Inadditiontotheinformationwhichispartofthebatchdocumentation,otherrawdatasuchaslaboratorynotebooksand/orrecordsshouldberetainedandreadilyavailable（歐盟GMP6.10）其它原始資料，如實驗室筆記本和/或統(tǒng)計，作為批統(tǒng)計的一部分，應(yīng)當(dāng)保存并容易讀取。26、label[?leb?l]vt.標注；貼標簽于；n.標簽；商標；簽條Labelsappliedtocontainers,equipmentorpremisesshouldbeclear,unambiguousandinthecompany’sagreedformat.（歐盟GMP5.13）容器、設(shè)備或設(shè)施所用標記應(yīng)清晰明了，其格式應(yīng)通過公司的同意。unlabeled未貼標簽的cut-label可切割式標簽mislabeling貼錯標簽的approvedlabel注冊商標labelingmaterial標簽材料productlabelling產(chǎn)品標簽openlabeltrial開放式臨床實驗cleaningstatuslabel清潔狀態(tài)標簽gang-printedlabeling多項印刷標簽27、validation[,v?l?'de??n]n.確認；同意；生效validate

['v?l?det]vt.證明，驗證；確認；使生效Validationofsystemstoensureaccuracy,reliability,consistentintendedperformance,andtheabilitytodiscerninvalidoralteredrecords.（ERES11.10）驗證系統(tǒng)，以確保系統(tǒng)的精確性、可靠性，持續(xù)穩(wěn)定地預(yù)期性能，確保系統(tǒng)能夠識別無效的或被修改的統(tǒng)計。processvalidation工藝驗證cleaningvalidation清潔驗證concurrentvalidation同時驗證validationmasterplan驗證主計劃（VMP）28、cell[s?l]n.細胞；電池；蜂房的巢室；單人小室；vi.住在牢房或小室中Reductioninbioburdenassociatedwithprocurementoflivingtissuesandcellsmayrequiretheuseofothermeasuressuchasantibioticsatearlymanufacturingstages.（歐盟GMP附錄235）減少與活性組織和細胞獲取有關(guān)的生物負荷可能需要采用其它方法，例如在早期生產(chǎn)階段使用抗生素。cellline細胞系cellbank細胞庫stemcell干細胞cellstrain細胞株cellculture細胞培養(yǎng)mastercellbank主細胞庫workingcellbank工作細胞庫29、person['p?sn]n.人；身體；容貌，外表；人稱personnel[,p?s?'n?l]n.人事部門；全體人員adj.人員的；有關(guān)人事的AllpartsofthePharmaceuticalQualitySystemshouldbeadequatelyresourcedwithcompetentpersonnel,andsuitableandsufficientpremises,equipmentandfacilities.（歐盟GMP原則）整個制藥質(zhì)量體系應(yīng)當(dāng)配備充足的并且能勝任的人員，以及充足并且使用的建筑物、設(shè)備和設(shè)施。responsibleperson負責(zé)人authorizedperson獲得授權(quán)的人QualifiedPerson質(zhì)量受權(quán)人（QP）personinchargeofenterprise公司負責(zé)人30、ensure[?n'??r]vt.確保，確保；使安全Storageareasshouldbedesignedoradaptedtoensuregoodstorageconditions.（歐盟GMP3.19）存儲區(qū)應(yīng)當(dāng)經(jīng)合理的設(shè)計或改造已確保含有良好的儲存條件。31、release[r?'lis]vt.釋放；發(fā)射；讓與；允許發(fā)表；n.釋放；公布；讓與Writtenreleaseandrejectionproceduresshouldbeavailableformaterialsandproducts,andinparticularforthecertificationforsaleofthefinishedproductbytheQualifiedPerson(s).（歐盟GM批4.27）應(yīng)當(dāng)有物料和產(chǎn)品放行與回絕的書面規(guī)程，特別是由質(zhì)量受權(quán)人放行上市銷售的成品。batchrelease批放行realtimerelease實時放行releaseprocedure放行程序parametricrelease參數(shù)放行finishedproductrelease成品放行32、specification['sp?s?f?'ke??n]n.規(guī)格；闡明書；詳述specificity[,sp?s?'f?s?ti]n.[免疫]特異性；特性；專一性specify['sp?s?fa?]vt.指定；具體闡明；列舉；把…列入闡明書Anylabelingorpackagingmaterialsmeetingappropriatewrittenspecificationsmaybeapprovedandreleasedforuse.（21CFR211.122b）任何標簽和包裝材料只有在符合書面規(guī)格原則的狀況下才能夠同意發(fā)放使用。out-of-specification超標（OOS）finishedproductspecification成品規(guī)格userrequirementsspecification顧客需求原則（URS）33、condition[k?n'd???n]n.條件；狀況；環(huán)境；身份；vt.決定；使適應(yīng)；使健康；以…為條件Intermediateandbulkproductsshouldbekeptunderappropriateconditions.（歐盟GMP5.41）中間體和半成品應(yīng)當(dāng)在適宜打的條件下儲存。asepticcondition無菌條件sanitarycondition衛(wèi)生條件storagecondition存儲條件transportcondition運輸條件environmentalcondition環(huán)境條件heating,ventilationandair-conditioning空調(diào)系統(tǒng)（HVAC）34、follow['fɑlo]vt.跟隨；遵照；追求；親密注意，注視；注意；傾聽vi.跟隨；接著；n.跟隨；追隨Normally,fillingandsealingshouldbefollowedasquicklyaspossiblebylabelling.（歐盟GMP5.54）普通的，灌裝和密封后，應(yīng)盡快貼標簽。asfollow以下35、storage['st?r?d?]n.存儲；倉庫；貯藏所store[st?r,stor]n.商店；貯存物；倉庫；大量v.貯存；（在計算機里）存儲Eating,drinking,chewingorsmoking,orthestorageoffood,drink,smokingmaterialsorpersonalmedicationintheproductionandstorageareasshouldbeprohibited.（歐盟GMP2.19）在生產(chǎn)區(qū)和存儲區(qū)，應(yīng)當(dāng)嚴禁飲食、飲水、咀嚼食物或吸煙，嚴禁寄存食物、飲料香煙或個人服用的藥品。coldstore冷藏庫storagesite儲存地點storagearea儲存區(qū)域storagecondition存儲條件storagecontainer儲存容器storagetemperature儲存溫度36、provide[pr?'va?d]vt.提供；規(guī)定；準備；裝備；vi.規(guī)定；撫養(yǎng)；作準備provided

[pr?'va?d?d]conj.如果；倘若v.提供；予以（provide的過去式）Thenumberofbatchesandfrequencyoftestingshouldprovideasufficientamountofdatatoallowfortrendanalysis.（歐盟GMP6.32）（穩(wěn)定性）考察的批次和檢查頻率應(yīng)能提供充足的數(shù)據(jù)，方便進行趨勢分析。37、take[tek]vt.拿，??；采用；接受；買，耗費；耗費vi.拿；獲得n.捕獲量；見解；利益，盈益；（入場券的）售得金額taken['tek?n]v.拿，帶（take的過去分詞）Samplesshouldberepresentativeofthebatchofmaterialsorproductsfromwhichtheyaretaken.（歐盟GMP6.12）所取的樣品應(yīng)當(dāng)是物料或產(chǎn)品批次中含有代表性的樣品。38、relevant['r?l?v?nt]adj.有關(guān)的；切題的；中肯的；有重大關(guān)系的；故意義的，目的明確的Documentsshouldbedesigned,prepared,reviewed,anddistributedwithcare.TheyshouldcomplywiththerelevantpartsofProductSpecificationFiles,ManufacturingandMarketingAuthorisationdossiers,asappropriate.（歐盟GMP4.2）應(yīng)當(dāng)對文獻進行精心設(shè)計、起草、審核與發(fā)放。文獻應(yīng)當(dāng)與對應(yīng)的“產(chǎn)品規(guī)格原則文獻”、“生產(chǎn)和上市許可注冊資料”的有關(guān)內(nèi)容一致。39、annex[??n?ks;??n?ks;(forn.)??n??ks]vt.附加；獲得；并吞;n.附加物；附屬建筑物Anyspecificrequirementsforthemanufactureofspecialgroupsofproducts,forexamplesterilepreparations,arecoveredintheannexes.（歐盟GMP2.22）不同類別產(chǎn)品的具體生產(chǎn)規(guī)定參見附錄，如無菌