疫苗行業(yè)相關(guān)標(biāo)準

-.z.序號標(biāo)準號名稱中國行業(yè)標(biāo)準SC1001-1992草魚出血病組織漿滅活疫苗SC7701-2007草魚出血病細胞培養(yǎng)滅活疫苗SN/T1306-2021入出境人員疫苗接種或預(yù)防措施國際證書簽發(fā)規(guī)程YY0573.3-2005一次性使用無菌注射器第3局部：自毀型固定劑量疫苗注射器A群C群腦膜炎球菌多糖疫苗GroupAandCMeningococcalPolysaccharideVaccineA群腦膜炎球菌多糖疫苗GroupAMeningococcalPolysaccharideVaccineb型流感嗜血桿菌結(jié)合疫苗HaemophilusInfluenzaeTypebConjugateVaccine白喉抗毒素DiphtheriaAntito*in凍干白喉抗毒素DiphtheriaAntito*in，F(xiàn)reezedried凍干多價氣性壞疽抗毒素GasgangreneAntito*in〔Mi*ed〕，F(xiàn)reezedried凍干甲型肝炎減毒活疫苗HepatitisAVaccine〔Live〕，F(xiàn)reeze-dried凍干靜注人免疫球蛋白〔pH4〕HumanImmunoglobulin〔pH4〕forIntravenousInjection，F(xiàn)reeze-dried凍干狂犬病人免疫球蛋白HumanRabiesImmunoglobulin，F(xiàn)reeze-dried凍干破傷風(fēng)抗毒素TetanusAntito*in，F(xiàn)reezedried凍干破傷風(fēng)人免疫球蛋白HumanTetanusImmunoglobulin，F(xiàn)reeze-dried凍干人免疫球蛋白HumanImmunoglobulin，F(xiàn)reezedried凍干人血白蛋白HumanAlbumin，F(xiàn)reezedried凍干人用狂犬病疫苗〔Vero細胞〕RabiesVaccineforHumanUse〔Verocell〕，F(xiàn)reeze-dried凍干肉毒抗毒素BotulinumAntito*ins，F(xiàn)reezedried凍干乙型肝炎人免疫球蛋白HumanHepatitisBImmunoglobulin，F(xiàn)reeze-dried凍干乙型腦炎滅活疫苗〔Vero細胞〕JapaneseEncephalitisVaccine〔VeroCell〕，Inactivated，F(xiàn)reeze-dried多價氣性壞疽抗毒素GasgangreneAntito*in〔Mi*ed〕風(fēng)疹減毒活疫苗〔人二倍體細胞〕RubellaVaccine〔HumanDiploidCell〕，Live風(fēng)疹減插活疫苗〔兔腎細胞〕RubellaVaccine〔R!bbitKidneyCedl〕，Live鉤端螺旋體疫苗LeptospiraVaccine口服脊髓灰質(zhì)炎減毒活疫苗〔猴腎細胞〕Poliomyelitis〔Live〕Vaccine〔MonkeyKidneyCell〕，Oral脊髓灰質(zhì)炎減毒活疫苗糖丸〔人二倍體細胞〕PoliomyelitisVaccineinDrageeCandy〔HumanDiploidCell〕，Live甲型肝炎滅活疫苗〔人二倍體細胞〕HepatitisAVaccine〔HumanDiploidCell〕，Inactivated甲乙型肝炎聯(lián)合疫苗HepatitisAandBbinedVaccine結(jié)核菌素純蛋白衍生物PurifiedProteinDerivativeofTuberculin〔TB－PPD〕靜注人免疫球蛋白〔pH4〕HumanImmunoglobulin〔pH4〕forIntravenousInjection卡介菌純蛋白衍生物PurifiedProteinDerivativeofBCG〔BCG－PPD〕抗狂犬病血清RabiesAntiserum抗人T細胞兔免疫球蛋白Anti-humanTLymphocyteRabbitImmunoglobulin抗人T細胞豬免疫球蛋白Anti-humanTLymphocytePorcineImmunoglobulin抗炭疽血清Anthra*Antiserum口服福氏宋內(nèi)菌痢疾雙價活疫苗DysenteryVaccine〔Live〕ofS.fle*neriandS.sonnei，Oral脊髓灰質(zhì)炎減毒活疫苗糖丸〔猴腎細胞〕PoliomyelitisVaccineinDrageeCandy〔MonkeyKidneyCell〕，live狂犬病人免疫球蛋白HumanRabiesImmunoglobulin流感病毒裂解疫苗InfluenzaVaccine〔SplitVirion〕，Inactivated流感全病毒滅活疫苗InfluenzaVaccine〔WholeVirion，Inactivated〕麻腮風(fēng)聯(lián)合減毒活疫苗Measles，MumpsandRubellabinedVaccine，Live麻疹風(fēng)疹聯(lián)合減毒活疫苗MeaslesandRubellabinedVaccine，Live麻疹減毒活疫苗MeaslesVaccine，Live麻疹腮腺炎聯(lián)合減毒活疫苗MeaslesandMumpsbinedVaccine，Live皮內(nèi)注射用卡介苗BCGVaccineforIntradermalInjection皮上劃痕人用布氏菌活疫苗BrucellosisVaccine〔Live〕forPercutaneousScarification皮上劃痕人用炭疽活疫苗Anthra*Vaccine〔Live〕forPercutaneousScarification皮上劃痕用鼠疫活疫苗PlagueVaccine〔Live〕forPercutaneousScarification破傷風(fēng)抗毒素TetanusAntito*in破傷風(fēng)人免疫球蛋白HumanTetanusImmunoglobulin人免疫球蛋白HumanImmunoglobulin人凝血酶原復(fù)合物HumanProthrombinple*人凝血因子ⅧHumanCoagulationFactorⅧ人纖維蛋白原HumanFibrinogen人血白蛋白HumanAlbumin人用狂犬病疫苗〔Vero細胞〕RabiesVaccineforHumanUse〔VeroCell〕人用狂犬病疫苗〔地鼠腎細胞〕RabiesVaccineForHumanUse〔PHKCell〕肉毒抗毒素BotulinumAntito*ins腮腺炎減毒活疫苗MumpsVaccine，Live森林腦炎滅活疫苗Tick-borneEncephalitisVaccine，Inactivated傷寒Vi多糖疫苗ViPolysaccharideTyphoidVaccine傷寒甲型副傷寒聯(lián)合疫苗TyphoidandParatyphoidAbinedVaccine傷寒甲型乙型副傷寒聯(lián)合疫苗TyphoidandParatyphoidA&BbinedVaccine傷寒疫苗TyphoidVaccine雙價腎綜合征出血熱滅活疫苗〔Vero細胞〕雙價腎綜合征出血熱滅活疫苗〔地鼠腎細胞〕HaemorrhagicFeverwithRenalSyndromeBivalentVaccine〔HamsterKidneyCell〕，Inactivated雙價腎綜合征出血熱滅活疫苗〔沙鼠腎細胞〕HaemorrhagicFeverwithRenalSyndromeBivalentVaccine〔GerbilKidneyCell〕，Inactivated外用重組牛堿性成纖維細胞生長因子RebinantBovineBasicFibroblastGrowthFactorforE*ternalUse外用重組人表皮生長因子RebinantHumanEpidermalGrowthFactorforE*ternalUse吸附白喉破傷風(fēng)聯(lián)合疫苗DiphtheriaandTetanusbinedVaccine，Adsorbed吸附白喉破傷風(fēng)聯(lián)合疫苗〔成人及青少年用〕DiphtheriaandTetanusbinedVaccineforAdultsandAdolescents，Adsorbed吸附白喉疫苗DiphtheriaVaccine，Adsorbed吸附白喉疫苗〔成人及青少年用〕DiphtheriaVaccineforAdultsandAdolescents，Adsorbed吸附百白破聯(lián)合疫苗Diphtheria，TetanusandPertussisbinedVaccine，Adsorbed吸附百日咳白喉聯(lián)合疫苗DiphtheriaandPertussisbinedVaccine，Adsorbed吸附破傷風(fēng)疫苗TetanusVaccine，Adsorbed吸附無細胞百白破聯(lián)合疫苗Diphtheria，TetanusandAcellularPertussisbinedVaccine，Adsorbed錫克試驗毒素SchickTestTo*in乙型肝炎人免疫球蛋白HumanHepatitisBImmunoglobulin乙型腦炎減毒活疫苗JapaneseEncephalitisVaccine，Live重組人白介素-2注射液RebinantHumanInterleukin-2Injection重組人促紅素注射液〔CHO細胞〕RebinantHumanErythropoietinInjection〔CHOCell〕重組人干擾素α2a注射液RebinantHumanInterferonα2aInjection重組人干擾素α2b注射液RebinantHumanInterferonα2bInjection重組人干擾素α2b注射液〔假單胞菌〕RebinantHumanInterferonα2bInjection〔P.putida〕重組人粒細胞刺激因子注射液RebinantHumanGranulocyteColonystimulatingFactorInjection重組乙型肝炎疫苗〔CHO細胞〕HepatitisBVaccineMadebyRebinantDNATechniquesinCHOCell重組乙型肝炎疫苗〔釀酒酵母〕HepatitisBVaccineMadebyRebinantDNATechniquesinSaccharomycesCerevisciaeYeast注射用A型肉毒毒素BotulinumTo*inTypeAforInjection注射用抗人T細胞CD3鼠單抗MouseMonoclonalAntibodyagainstHumanCD3AntigenofTLymphocyteforInjection、注射用重組鏈激酶RebinantStreptokinaseforInjection注射用重組人白介素-2RebinantHumanInterleukin-2forInjection注射用重組人促紅素〔CHO細胞〕RebinantHumanErythropoietinforInjection〔CHOCell〕注射用重組人干擾素α1bRebinantHumanInterferonα1bforInjection注射用重組人干擾素α2aRebinantHumanInterferonα2aforInjection注射用重組人干擾素α2a〔酵母〕RebinantHumanInterferonα2aforInjection〔Yeast〕注射用重組人干擾素α2bRebinantHumanInterferonα2bforInjection注射用重組人干擾素α2b〔假單胞菌〕RebinantHumanInterferonα2bforInjection〔P.putida〕注射用重組人干擾素2b〔酵母〕RebinantHumanInterferon2bforInjection〔Yeast〕注射用重組人干擾素γRebinantHumanInterferonγforInjection注射用重組人粒細胞巨噬細胞刺激因子RebinantHumanGranulocyte/MacrophageColony-stimulatingFactorforInjection生物制品包裝規(guī)程生物制品分批規(guī)程生物制品分裝和凍干規(guī)程生物制品國家標(biāo)準物質(zhì)制備和標(biāo)定規(guī)程生物制品生產(chǎn)和檢定用動物細胞基質(zhì)制備及檢定規(guī)程生物制品生產(chǎn)檢定用菌毒種管理規(guī)程免疫血清生產(chǎn)用馬匹檢疫和免疫規(guī)程生物制品質(zhì)量控制分析方法驗證技術(shù)審評一般原則生物制品貯藏和運輸規(guī)程疫苗流通和預(yù)防接種管理條例疫苗儲存和運輸管理標(biāo)準治療用生物制品非臨床平安性技術(shù)審評一般原則中國生物制品主要原輔材料質(zhì)控標(biāo)準中國地方標(biāo)準DB37/T1210-2021豬繁殖與呼吸綜合征油乳劑滅活疫苗〔SD1株〕免疫技術(shù)標(biāo)準DB43/T371-2007魚類嗜水氣單胞菌滅活疫苗制作規(guī)程DB21/T1764-2021獸用疫苗冷鏈建立技術(shù)與管理標(biāo)準DB45/T588-2021水產(chǎn)養(yǎng)殖魚類細菌病組織漿疫苗制備與應(yīng)用標(biāo)準DB23/T888-2005獸用疫苗貯存、運輸和使用標(biāo)準DB35/T989-2021豬瘟活疫苗原料兔WHO標(biāo)準TRS(TechnicalReportSeries)No.745Requirementsfordriedbcgvaccine,Anne*2凍干卡介苗質(zhì)量要求，附錄2TRSNo.771RequirementsfordriedBCGvaccine,Anne*12凍干卡介苗質(zhì)量要求，附錄12TRSNo.924Guidelinesfortheproductionandcontrolofinactivatedoralcholeravaccine,Anne*3滅活口服霍亂疫苗的生產(chǎn)和質(zhì)量控制指南，附錄3TRSNo.932Guidelinesfortheproductionandqualitycontrolofcandidatetetravalentdenguevirusvaccines(live),Anne*1備選四價登革病毒疫苗的生產(chǎn)和質(zhì)量控制指南，附錄1TRSNo.927RemendationsforDTPandbinedvaccines,Amendments2003,Anne*5百白破和聯(lián)合疫苗建議，2003年修正版，附錄5TRSNo.800RequirementsforDTP,Anne*2百白破疫苗質(zhì)量要求，附錄2TRSNo.941Guidelinesforassuringthequalityandnon-clinicalsafetyevaluationofDNAvaccines,Anne*1DNA疫苗的非臨床平安評價和質(zhì)量確認指南，附錄1TRSNo.848Requirementsforhaemorrhagicfeverwithrentalsyndrome(HFRS)vaccine(inactivated),Anne*2腎綜合癥出血熱疫苗〔滅活〕的質(zhì)量要求，附錄2TRSNo.897RemendationsfortheproductionandcontrolofHaemophilusinfluenzaetypebconjugatevaccines,Anne*1B型流感嗜血桿菌結(jié)合疫苗的生產(chǎn)和控制建議，附錄1TRSNo.858RequirementsforhepatitisAvaccines(inactivated),Anne*2甲型肝炎疫苗〔滅活〕質(zhì)量要求，附錄2TRSNo.771RequirementsforheptatitisBvaccinepreparedfromplasma,Anne*8由血漿制備的乙型肝炎疫苗的質(zhì)量要求，附錄8TRSNo.786TRSNo.889Remendationstoassurethequality,safetyandefficacyofrebinanthepatitisBposedreplacementof:LTRS786,Anne*2andTRS889,Anne*4重組乙肝疫苗的質(zhì)量、平安和效力確認建議〔建議由TRS786附錄2和TRS889附錄4代替〕WHO/BS/06.2050Guidelinestoassurethequality,safetyandefficacyofrebinanthumanpapillomavirusvirus-likeparticlevaccines重組人乳頭瘤病毒病毒樣顆粒疫苗的質(zhì)量、平安和效力確認指南TRSNo.927Remendationsfortheproductionandcontrolofinfluenzavaccine(inactivated),Anne*3滅活流感疫苗的生產(chǎn)和控制建議，附錄3WHO/IMD/PUB/04.1WHOremendationstoassurethequality,safetyandefficacyofinfluenzavaccines(human,liveattenuated)forintranasaladministrationWHO對鼻腔給藥人類減活流感疫苗的質(zhì)量、平安和效力確認的建議TRSNo.941WHObiosafetyriskassessmentandguidelinesfortheproductionandqualitycontrolofhumaninfluenzapandemicvaccines,Anne*5WHO對人類流感疫苗的生產(chǎn)和質(zhì)量控制的指南和生物平安風(fēng)險評價，附錄5TRSNo.941H1N1specific-updateofTRS941,Anne*5對與H1N1的TRS941的細節(jié)更行，附錄5WHO/BS/07.2074Proposedguidelines:regulatorypreparednessforhumanpandemicinfluenzavaccines人類流感疫苗的監(jiān)管準備的建議指南WHO/BS/07.20644ProposedrevisionremendationsforJapaneseencephalitisvaccine(inactivated)forhumanuse人用滅活乙型腦炎疫苗的修正建議TRSNo.910GuidelinesfortheproductionandcontrolofJapaneseencephalitisvaccine(live)forhumanuse,Anne*3人用活乙型腦炎疫苗的生產(chǎn)和控制指南，附錄3TRSNo.840Requirementsformeasles,mumpsandrubellavaccinesandbinedvaccine(live),Anne*3麻疹、流行性腮腺炎、風(fēng)疹疫苗和活麻腮風(fēng)聯(lián)合疫苗的質(zhì)量要求，附錄3WHO/BS/06.2041Remendationstoassurethequality,safetyandefficacyofgroupameningococcalconjugatevaccinesA群腦膜炎球菌結(jié)合疫苗的質(zhì)量、平安和效力確認建議TRSNo.924RemendationsfortheproductionandcontrolofMeningococcalgroupCconjugatevaccines,Anne*2C群腦膜炎球菌結(jié)合疫苗的生產(chǎn)和控制建議，附錄2TRSNo.926RemendationsfortheproductionandcontrolofgroupCmeningococcalconjugatevaccines,Addendum2003,Anne*3C群腦膜炎球菌結(jié)合疫苗的生產(chǎn)和控制建議，2003年附件的附錄2WHO/BS/07.2065ClinicalevaluationofgroupCmeningococcalconjugatevaccinesC群腦膜炎球菌結(jié)合疫苗的臨床平安評價TRSNo.904Requirementsformeningococcalpolysaccharidevaccine(Amendment1999),Anne*2腦膜炎球菌多糖疫苗質(zhì)量要求〔1999年修正〕，附錄2TRSNo.658Requirementsformeningococcalpolysaccharidevaccine,Addendum1980,Anne*6腦膜炎球菌多糖疫苗質(zhì)量要求〔1999年修正〕，1980附件附錄2TRSNo.594Requirementsformeningococcalpolysaccharidevaccine:Adopted1975,Anne*2腦膜炎球菌多糖疫苗質(zhì)量要求，1975年被采用，附錄2TRSNo.848NOTE:requirementsformeasles,mumpsandrubellavaccinesandbinedvaccine(live)(requirementsforbiologicalsubstancesNO.47)說明：麻疹、流行性腮腺炎、風(fēng)疹疫苗和活麻腮風(fēng)聯(lián)合疫苗的質(zhì)量要求〔生物物質(zhì)NO.47質(zhì)量要求〕TRSNo.941Remendationsforwholecellpertussisvaccine,Anne*6全細胞百日咳疫苗建議，附錄6TRSNo.800Requirementsfordiphtheria,tetanus,pertussisandbinedVaccines,Anne*2百白破聯(lián)合疫苗質(zhì)量要求，附錄2TRSNo.927Remendationsfordiphtheria,tetanus,pertussisandbinedVaccines,Amendment2003,Anne*5百白破聯(lián)合疫苗建議，2003年修正，附錄5TRSNo.878Guidelinesfortheproductionandcontroloftheacellularpertussisponentofmonovalentorbinedvaccines,Anne*2無細胞百日咳單價或聯(lián)合疫苗的生產(chǎn)和控制指南，附錄2TRSNo.927Remendationstoassurethequality,safetyandefficacyofpneumococcalconjugatevaccines-proposedreplacementofTRS927,Anne*2肺炎球菌結(jié)合疫苗的質(zhì)量、平安和效力確認建議〔由TRS927代替〕，附錄2TRSNo.926Guidelinesforthesafeproductionandqualitycontrolofinactivatedpoliomyelitisvaccinemanufactureredfromwildpolioviruses(Addendum2003toremendationsfortheproductionandqualitycontrolofpoliomyelitisvaccine(Inactivated)),Anne*2從野生脊髓灰質(zhì)炎病毒生產(chǎn)的脊髓灰質(zhì)炎滅活疫苗的生產(chǎn)和質(zhì)量控制指南〔滅活脊髓灰質(zhì)炎疫苗的生產(chǎn)和質(zhì)量控制建議的2003年附件〕，附錄2TRSNo.910Remendationsfortheproductionandcontrolofpoliomyelitisvaccine(Inactivated),Anne*2滅活脊髓灰質(zhì)炎疫苗的生產(chǎn)和控制建議，附錄2TRSNo.910Remendationsfortheproductionandcontrolofpoliomyelitisvaccine(oral)(Addendum2000),Anne*1口服脊髓灰質(zhì)炎疫苗的生產(chǎn)和控制建議〔2000年附件〕，附錄2TRSNo.904Remendationsfortheproductionandcontrolofpoliomyelitisvaccine,oral;Revised1999,Anne*1口服脊髓灰質(zhì)炎疫苗的生產(chǎn)和控制建議，1999年修正，附錄1TRSNo.941Remendationsforinactivatedrabiesvaccineforhumanuseproducedincellsubstratesandembryonatedeggs,Anne*2在細胞基質(zhì)和雞胚中生產(chǎn)的人用滅活狂犬病疫苗建議，附錄2TRSNo.658Requirementsforrabiesvaccineforhumanuse,Revised1980,Anne*2人用狂犬病疫苗質(zhì)量要求，1980年修正，附錄2TRSNo.673Requirementsforriftvalleyfevervaccines;Adopted1981,Anne*4裂谷熱疫苗的質(zhì)量要求，1981年采用，附錄4TRSNo.941Guidelinestoassurethequality,safetyandefficacyofliveattenuatedrotavirusvaccines(oral),Anne*3口服減活輪狀病毒疫苗的質(zhì)量、平安和效力確認指南，附錄3TRSNo.840Requirementsformeasles,mumpsandrubellavaccinesandbinedvaccines,live,Anne*3麻疹、流行性腮腺炎、風(fēng)疹疫苗和麻腮風(fēng)聯(lián)合疫苗的質(zhì)量要求，附錄3TRSNo.926Remendationsfortheproductionandqualitycontrolofsmallpo*vaccines,Anne*1天花疫苗的生產(chǎn)和質(zhì)量控制建議，附錄1TRSNo.889Guidelinesfortheproductionandqualitycontrolofsyntheticpeptidevaccines;Adopted1997,Anne*1合成肽疫苗的生產(chǎn)和質(zhì)量控制指南，1997年采用，附錄1TRSNo.880Requirementsfordiphteria,tetanus,pertussisandbinedvaccines,Anne*2百白破聯(lián)合疫苗的質(zhì)量要求，附錄2TRSNo.927Remendationsfordiphtheria,tetanus,pertussisandbinedvaccines,Amendments2003,Anne*5百白破聯(lián)合疫苗建議，2003年修正，附錄5TRSNo.889Requirementsfortick-borneencephalitisvaccine(inactivated),Adopted1997,Anne*2滅活森林腦炎病毒疫苗的質(zhì)量要求，1997年采用，附錄2TRSNo.840Requirementsforvipolysaccharidetyphoidvaccine;Adopted1992,Anne*1傷寒Vi多糖疫苗的質(zhì)量要求，1992年采用，附錄1TRSNo.361Requirementsfortyphoidvaccine;Adopted1966,Anne*4傷寒疫苗質(zhì)量要求，1996年采用，附錄4TRSNo.700Requirementsfortyphoidvaccine(Live,attenuated,Ty21a,oral),Anne*3傷寒疫苗質(zhì)量要求〔口服減毒活Ty21a株〕，附錄3TRSNo.848Requirementsforvaricellavaccine(Live);Revised1993,Anne*1活水痘疫苗質(zhì)量要求，1993年修正，附錄1TRSNo.872Remendationstoassurethequality,safetyandefficacyofliveattenuatedyellowfevervaccines.黃熱病減毒活疫苗的質(zhì)量、平安和效力確認建議。TRSNo.786Requirementsforhumaninterferonsfromlymphoblastoidcells,Anne*3從幼成淋巴細胞而來的人類干擾素的質(zhì)量要求，附錄3TRSNo.771RequirementsforhumaninterferonsbyrebinantDNAtechniques,Anne*7利用從組DNA技術(shù)生產(chǎn)的人類干擾素的質(zhì)量要求，附錄7Remendationsfortheevaluationofanimalcellculturesassubstratesforthemanufactureofbiologicalmedicinalproductsandforthecharacterizationofcellbanks.動物細胞基質(zhì)生產(chǎn)生物醫(yī)藥產(chǎn)品和細胞庫特性的評價建議TRSNo.924Guidelinesonclinicalevaluationofvaccines:regulatorye*pections,Anne*1疫苗臨床評價指南：監(jiān)管期望，附錄1TRSNo.822Biologicalproducts,GMP,Anne*1生物制品，GMP，附錄1TRSNo.908WHOe*pertmitteeonspecificationsforpharmaceuticalpreparationsWHO專家委員會藥物制劑規(guī)則TRSNo.932Guidelinesforindependentlotreleaseofvaccinesbyregulatoryauthorities.監(jiān)管機構(gòu)獨立批量簽發(fā)疫苗操作指南TRSNo.927WHOguidelinesonnonclinicalevaluationofvaccines,Anne*1WHO非臨床評價疫苗操作指南，附錄1TRSNo.822Guidelinesfornationalauthoritiesonqualityassuranceforbiologicalproducts,Anne*2國家管理機構(gòu)對生物制品的質(zhì)量保證的監(jiān)管操作指南TRSNo.858Regulationandlicensingofbiologicalproductsincountrieswithnewlydevelopingregulatoryauthorities,Anne*1各個國家新成立的監(jiān)管機構(gòu)對生物制品的管理和許可WHO/BS/06.2049Guidelinesonstabilityevaluationofvaccines疫苗穩(wěn)定性評價指南TRSNo.530GeneralrequirementsforthesterilityofbiologicalsubstancesRevised1973,Anne*4生物基質(zhì)滅菌一般要求，1973年修正，附錄4TRSNo.926Guidelinesonregulatorye*pectationsrelatedtotheelimination,reductionorreplaceofthiomersalinvaccines,Anne*4疫苗中硫柳汞的去除、減少或者代替相關(guān)的監(jiān)管期望操作指南WHOguidelinesontransmissiblespongiformencephalopathiesinrelationtobiologicalandpharmaceuticalproducts.WHO操作指南：感染性海綿狀腦病相關(guān)的生物和藥物產(chǎn)品美國標(biāo)準DODA-A-54803-1993influenzavirusvaccine,USP流感病毒疫苗，美國藥典GOST15991-1986Liveanthra*vaccineSTIforanimals.Specificatio