证书申请递交的质量综述模板 QOS

1、Templatte forr Quallity OOveralll Summmary to be ssubmittted ffor Ceertifiicatioon appplicattions证书申请递交的的质量综述模模板NB: Reeferennce: PA/PHH/CEP (04) 1 (ass reviised) Conttent oof thee dosssier ffor chhemicaal purrity aand miicrobiiologiical qqualitty (caan be downlloadedd fromm EDQMM webssite HYPERLINK

2、http:/www.edqm.eu hhttp:/www.edqm.eu) qualityy overrall ssummarry质量综述Substannce naame产品名名称Monograaph n个论号Subtitlle (iff any)副标题（如果有有的话）Intendeed Hollder oof thee CEPCEP证书持有有人Writtenn by 撰撰写人Qualifiicatioon*资质Date日期(*): aappendd CV oof thee expeertquaality overaall suummaryy2.3.S DDRUG SSUBSTAANCE原料料

3、药 2.3.S.11 Geneeral IInformmationn一般信息 Use of the ssubstaance:Routee(s) oof admministtratioon, maaximumm dailly dosse.用途：（给药途途径，每日最最大剂量）Commerccialissationn histtory: Summaarise the hhistorry bassed onn the tablee in aappliccationn formm).贸易历史：（按按申请表中的的概述）Declaraationss: Suummariise thhe decclaratti

4、ons appennded tto thee appllicatiion foorm:声明：（概述附附于申请表后后的声明）- Manuffacturre of the ssubstaance iin acccordannce wiith ICCH Q7AA GMP ruless 该原料药生产遵遵循了ICHH Q7A GMP法规规条款- Commiitmentt by tthe maanufaccturerr to kkeep tthe prroposeed hollder iinformmed off any changges too the docummentattion.生产商的承诺：任何

5、文件变变更都会及时时通知持有人人- if appplicaable: Manuufactuurerss authhorisaation for XX to aact ass reprresenttativee生产商对某人作作为代表人的的授权书（如如果有的话）- Williingnesss to be innspectted (hholderr, mannufactturerss)愿意接受现场检检查（持有人人，生产商）- Non-uuse/usse of materrials of huuman oor aniimal ooriginn in tthe prrocesss生产过程中未使使用/使用

6、了了来源于人或或动物的物料料2.3.S.11.1 Noomencllaturee 命名(a) Reccommennded IInternnationnal Noon-proopriettary nname (INN):国际非专有有名称(b) Cheemicall namee(s):化化学名(c) Commpany or laaborattory ccode:公公司或实验室室编码(d) Othher noon-proopriettary nname(ss) (e.g., nnationnal naame, UUSAN, BAN):其他非专利利名称（如，国国家命名，美美国采用名，英英国认可名）(e

7、) CASS No.Moleccular Formuula分子式式MW: 分子子量2.3.S.11.3 Geenerall Proppertiees特性Give suummariised ddata oon:提供以以下信息 (a) Phhysicaal desscripttion (e.g., appeearancce, coolour, physsical statee)形状描述（如：外观、颜色色、物理状态态）(b) Phyysicall formm (e.gg., poolymorrphic form, solvvate, hydraate): to bee commmentedd esp

8、eeciallly if requeested as grrade.物理形态（如：多晶型，溶溶剂化物，水水合物）：按按要求分级别别作出描述(c) Sollubiliity annd othher prropertties aas neccessarry 溶解性，及其他他相关特性(d) Parrticlee sizee:e.g. noon-miccronissed, miicroniised or aany grrade cclaimeed as subtiitle.粒度（如：非微微粒、微粒，或其他级级别说明，作作为小标题）2.3.S.22 Manuufactuure生产2.3.S.22.1 M

9、aanufaccturerr(s) (name, manuufactuurer) and ssites invollved iin thee entiire prrocesss生产商（产品名名，公司名），及及整个生产过过程中涉及的的场所Give thhe namme, adddresss and respoonsibiility of eaach maanufaccturerr, inccludinng conntracttors aand maanufaccturerr and each propoosed pproducction site or faacilitty invvolvedd

10、 in mmanufaacturee.提供每个生产商商的名称、地地址、责任，包括承包商和生产商，以及生产过程涉及的每个拟定生产地点或设备2.3.S.22.2 Deescripption of Maanufaccturinng Proocess and PProcesss Conntrolss 生产工艺和工艺艺控制的描述述(a) Givve a bbrief narraative step-by-sttep deescripption of thhe mannufactturingg proccess(ees) annd proovide referrence to deetaileed des

11、scripttion iin thee docuumentaation. Conffirm tthe maaximumm batcch sizze 简要工艺描述，提提供记录中详详细描述作为为参考。证实实最大批量。(b) If appliicablee summmarisee alteernatee proccessess and give a shoort exxplanaation of thheir uuse:如果有的话，概概述变更工艺艺，并简短说说明原因(c) Commment shorttly onn recoovery of maateriaals (ssolvennts, rrea

12、gennts, aand moother liquoor) toogetheer witth repprocesssing stepss and give a briief juustifiicatioon:简单说明物料回回收（溶剂、试试剂和母液）和和再回收步骤骤，并提供主主要理由2.3.S.22.3 Coontroll of MMateriials物料料控制I) Starrting materrial(ss)起始物料料 (a) Giive suummariised sspecifficatiions (incluuding impurritiess proffile) incluuding

13、theirr justtificaation basedd on sstudiees of carryy-overr. 提供质量标准（包包括杂质概况况），并给出出残留物研究究的合理证明明NB:If startting mmateriial iss obtaained by feermenttationn or iis froom herrbal ooriginn, summmarisse thee infoormatiion reelatedd to tthe naature of thhis maateriaal.注：如果起始物物质为从发酵酵或植物提取取中获得，概概述这种物料料性质的相关关信

14、息。II) Reaagentss and solveents试剂剂和溶剂Summariise thhe quaality and ccontrools off the materrials (e.g., raww mateerialss, sollventss puree and/or reecoverred, rreagennts, ccatalyysts) used in thhe mannufactture oof thee drugg subsstancee.概述原料药生产产中用到的物物料质量和控控制信息（如如：原材料，纯纯溶剂或回收收溶剂，试剂剂，催化剂）2.3.S.22.4 Coo

15、ntrolls of Critiical SSteps and IIntermmediattes关键步步骤和中间体体的控制Summaryy of tthe coontrolls perrformeed at critiical ssteps of thhe mannufactturingg proccess and oon inttermeddiatess, commpare analyyticall proccedurees useed forr inteermediiates and ffinal substtance.概述生产工艺以以及对于中间间体的关键步步骤的控制信信息，以及对对中间体

16、和最最终产品的比比较分析方法法2.3.S.22.5 Prrocesss Valiidatioon andd/or EEvaluaation工工艺验证和/或评估For aseeptic proceessingg and steriilizattion oonly ggive tthe suummaryy of pprocesss vallidatiion annd/or evaluuationn studdies. 对无菌操作和灭灭菌的工艺验验证和/或评评估提供概述述2.3.S.33 Charracterrisatiion特性2.3.S.33.2 Immpuritties 杂杂质(I) Rell

17、ated substtancess有关物质(a) Filll in the ffollowwing ttable identtifyinng rellated substtancess, theeir orrigin and ddistinnguishhing bbetweeen pottentiaal andd actuual immpuritties aand coompariing wiith immpuritty secction of thhe monnograpph:将有关物质填入入下表，包括括来源，潜在在的和实际存存在的杂质区区别，以及药药典中对应的的杂质章节Chemicaal

18、namme化学名称PhEur iimpuriityEP杂质Applicaants speciificattions申请规格PhEur sspecifficatiionsEP标准Origin来源Levels foundd级别LODof the methood检测限LOQof the methood定量限(b)Justtify tthese speciificattions basedd on ddata oobservved foor imppuritiies inn releevant batchhes 证明这些标准建建立于典型批次的杂杂质研究资料料之上(c) Disscuss brieffl

19、y abbout tthe suuitabiility of thhe monnograpph to contrrol thhe pottentiaal imppuritiies prresentt in tthe suubstannce (rresiduual sttartinng matterialls, reeactannts annd reaagentss etc.) 简要讨论药典对对于原料药中中存在的潜在在杂质控制的的适应性（残残留起始物质质、反应物和和试剂等） (d)speecificc disccussioon on possiible ggenotooxic iimpuriit

20、ies: 对于可能存在的的具有基因毒毒性杂质的特特别说明Give a brieff disccussioon on impurritiess withh poteentiall genootoxiccity bbased on thhe reqquiremments of thhe guiidelinne (EMMEA /CCHMP /QWP /2513444 /20006). 应指导方针(EEMEA /CHMP /QWP /2513344 /22006)要求，对有有潜在基因毒毒性的杂质进行简单单讨论。II.Resiidual solveent(s) / reeagentt(s) / cata

21、alyst(s)残留溶溶剂/试剂/催化剂Fill inn the folloowing tablee 填写下表表Solventt/reaggent/ccatalyyst溶剂/试剂/催催化剂Used inn stepp x/yApplicaants limitt 申请限度ICH claass / limittICH限度Levels (ppm)级别LOD of the mmethoddLOQ of the mmethodd(b)Disccuss bbrieflly thee basiis forr settting tthe sppecifiicatioon:简要说明设设定标准的依依据2.3.S.

22、44 Conttrol oof thee Drugg Subsstancee原料药控制制2.3.S.44.1 Sppecifiicatioon 规格Give a tablee summmarisiing thhe prooposedd speccificaationss.给出已有规格的的表格清单2.3.S.44.2 Annalytiical PProceddures分分析方法(a) Summmarisse of the aanalyttical proceeduress 概述分析方法2.3.S.44.3 Vaalidattion oof Anaalyticcal Prroceduures分析析

23、方法的验证证 Give tthe suummaryy of tthe vaalidattion iinformmationn for any iin-houuse teests aand coomparee shorrtly wwith tthe meethod(s) deescribbed inn the monoggraph (crosss vallidatiion).提供对于任何内内部检测的验验证信息，并并与药典中（贯贯穿验证）的的方法进行简简单比较2.3.S.44.4 Baatch AAnalysses批分析析(a) Givve a sshort descrriptioon of th

24、e bbatchees: Baatch NNumberr Batcch Sizze Datte andd Sitee of PProducction批次的简单描述述：批号，批批量，生产日日期，生产场场所(b) Summmarisse thee resuults ffor reelevannt battches (accoordingg to sspecifficatiions aand shhowingg equiivalennce off any alterrnativve suppplierr, proocess etc):概述对典型批次次分析的结果果（依据规格格，叙述任一一变更供应商商或

25、工艺的等等效性，等等等）2.3.S.44.5 Juustifiicatioon of Speciificattion规格格标准的论证证Justifyy the drug substtance speciificattion 论证原料药的规规格标准2.3.S.55 Refeerencee Stanndardss or MMateriials 参参比标准品和和参比物质(a) Givve thee sourrce off primmary rrefereence sstandaards oor refferencce matterialls (e.g.,Phh.Eur.) forr finaal s

26、ubbstancce andd its impurritiess wherre rellevantt.提供为最终原料料药使用的基基准参比标准品或参比比物质的来源源（如：EPP），以及相相关杂质(b) Summmarisse chaaracteerizattion aand evvaluattion oof in-housee stanndardss. 概述特性及内部部标准的评估估2.3.S.66 Conttainerr Clossure SSystemm 容器密闭闭系统(a) Desscribee shorrtly tthe coontainner cllosuree systtem(s) f

27、or the sstoragge andd shippment of thhe druug subbstancce, ass it hhas too be mmentiooned oon thee CEP in caase a re-teest peeriod is reequestted (ii.e. iin a cclear and uundersstandaable mmannerr).简要描述用于原原料药贮存和和运输的容器器密闭系统，在CEP中应被提及以防复测期需要（即，用一种清楚明白的方式）(b) Summmarisse thee speccificaationss (desscri

28、pttion + idenntificcationn)概述规格（种类类+鉴定）2.3.S.77 Stabbilityy 稳定性研研究State rre-tesst perriod cclaimeed forr the substtanceand sstoragge reccommenndatioons iff any:如果有的话，列列出对于原料料药及贮存建建议的复测期期声明2.3.S.77.1 Sttabiliity Suummaryy and Concllusionns 稳定性性研究总结和和结论 (a) Suummariise acccelerrated and loong teerm te

29、estingg (e.gg., sttudiess condductedd, prootocolls useed, reesultss obtaained).概述加速和长期期试验（如：研究方式，使使用草案，研研究结果）(b) Jusstify of thhe re-test periood claaimed basedd on ddata aavailaable.证明声明的复测测期基于有效的的数据2.3.S.77.2 Poost-appprovaal Staabilitty Prootocoll and Stabiility Commiitmentt批准后稳定定性研究方案案和稳定性研研究承诺 Give tthe sttabiliity prrotocool forr commmitmennt battches提供承诺批次的的稳定性方案案COMPLEMMENTARRY INFFORMATTION TTO BE PROVIIDED提供的补充资料料I Testts neeeded iin addditionn / reeplaceement of thhe tessts off the monoggraph附加或代替药典典方法的试验验Give a summaary off the addittion