ࡱ>   !"#$%&'()*+,-./0123456789:;<=>?@ABCDENGHIJKLMROPQSTRoot Entry F@1SummaryInformation(DocumentSummaryInformation8xWordDocument6 Oh+'0l   (0d Xtzj.User78E9B359.dotmwxl2@L&@BC1@[v\"Microsoft Office Word՜.+,D՜.+,HPXt|  Xtzj.ComIO( (\dlKSOProductBuildVer2052-10.1.0.76980TableFData WpsCustomData P>NKSKS6"D8$ l t ($YhB :h,  DN1 Sf[oTl\BRN6Ro(ϑTuHe N'`ċNb/gBl _Bla?z N0;`SOBl 3uN^hQbN] N^l\BRvVQY N^̀of0[hQ'`T gHe'`penc0 N^T NoS^vKm`Q ċNTnxvQ4N^Ne[svvKm0 4.lQyb7hTybϑSgqS^v 0Sf[N6RolQybuNĉ!jvN,'`BlՋL 0gbL0 Te^cNlQybybuNU_SuN]zOo`h0 V0SS(ϑc6Rb/gBl N Seo 6RBRuNFU~TSeouN]z 9hncs gc[SRTvsQeN+TV[@\2008t^7Se [Seov(ϑۏLEQRxvzNċ0O _eO gsQir(hgel XRnmon^Nr0nBRkYu0~̃Qk }0_uirP^I{hg v^cOvsQvDe Nnl\BR]zT(ϑvc6RBl TesQl[CQ }Bg(TzSBg(vxvzTċ0O0 6RBRuNFU9hncl\BRc~3z[uNv [SeoegnT(ϑۏLhQbv[Tċ0O (WT~vFUNSuN-NOO^v3z[0YSuSf ۏLxvzv^ cvsQb/gc[SRۏLxvzT3ub0 N e e^&{Tl\(uBl 6R[%NfW'`SS NSk6RBRۏL g['`v[kxvz fvQSSE^^NSk6RBRI{ T0 SgqICH Q1BBlۏLIQgq3z['`xvz0 l\BR3z['`xvzvRՋ0gՋ^(W&{TGMPagN NۏL S~TQ3ubl\BRNTvyrp YNTĉenagN0S7hep0[ch0RgelSScSP^08^ byb!kv3z['`ՋeHhN3ubyb!kveHhv T gSS cOyf[Ttvt1u03uNb(WNT_ybQT ~~[]zybۏL3z['`[FUNSybϑSuSSe [gRǏuNv3ybFUNSĉ!juNvNTۏL3z['`Ջ0 N0yrkl\BRN'`ċNvW,gQ yrkl\BRY(SO0Y sN0_t0m`Wl\BRI{ N'`ċN(W cgq Nb/gBl_U\xvzv Te ؏9hncyrkl\BRvyrp SgqFDA0EMAS^vyrk6RBRvsQb/gBl yf[Ջ0^sQlN N N Ye]z YeSR N^NSk6RBRN ^[evWSSSq_Tl\BRSOQL:NvevCQAۏLxvz0 yrkl\BRvuN]zSq_ToirSOQL:N meQxvzǑ(uẽ]zuNvyrkl\BR yr+RlaTuNekvẽOceT0 lQybTFUNybvuN]zSybϑSR N^OcN0 N (ϑxvz [vsQ.(ϑ^\'`SSbFO NPNN NQ[tS'`(Y'`r0Ϟ^ nSid\Sm^ pH

eL:N 8nyT~Toir oirvfWT~vfb_`0 SR N^cO\3yb!kSk6RBR7hTv(ϑ[k[penc0  N BE/4N^ՋvQ ^Ǒ(uFUNybϑv7hTۏLBEՋT/b4N^Ջ0 [NFDAbEMA]lQ^c[SRvyr[l\BRTy ^SgqvQb/gBl_U\NSk6RBRv[kxvz0 kQ09eĉe\'`oirY099mTc0 I{Tye_U\N'`ċN ۏL(ϑcGSxvz mp̃]z0nhVNSPg b+Tv['`xvz I{^&{TvsQb/gBl0 Se.s 1.ICH Steering Committee, Harmonised Tripartite Guideline Q8: Pharmaceutical Development. August, 2009 2.ICH Steering Committee. Harmonised Tripartite Guideline Q1A: Stability Testing of New Drug Substances and Products. 2003 3.ICH Steering Committee. Harmonised Tripartite Guideline Q3D: Guideline for Elemental Impurities. 2014 4.ICH Steering Committee. Harmonised Tripartite Guideline M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. 2017 5.V[ߘToTvcw{t;`@\. 0Sf[oTelQR{|3ubDeBlՋL 02016t^,{80S 6.Sf[oTl\BRW,gb/gBlՋL (Vߘovl0200807S) 7.V[ߘToTvcw{t;`@\oT[ċ-N_. 0mp̃/ẽ]zc[SR 0_Bla?z 2013t^8g 8.V[oTvcw{t@\. 0d̃Ǐnb/gS^(ucWS 02018t^,{85S 9.V[ߘToTvcw{t;`@\. 0Sf[oirSeoT6RBR 3z['`xvzb/gc[SRO 02015t^,{3S 10.V[ߘToTvcw{t;`@\. 0Sf[oTl\BRNQXeSňPgev['`xvzb/gc[SRՋL 0Vߘovl020120267S 11.V[ߘToTvcw{t;`@\. 0Sf[oTl\BRNo(ustSň[hVv['`xvzb/gc[SRՋL 02015t^,{40S 12.V[ߘToTvcw{t;`@\. 0Sf[oTN9_'`SO[\Nv['`xvzb/gc[SRՋL 02018t^,{14S 13. V[oTvcw{t@\oT[ċ-N_. 0Sf[N6RolQybuNĉ!jvN,'`BlՋL 02018t^6g 14. V[oTvcw{t@\. 0Sf[N6RoSk6RBRt Nnx[ z^ 02019t^,{25S 15. V[ߘToTvcw{t@\. 0sQNR:_o(ustSňl\BRoTvcw{tvw 0(ߘovRl020120132S) 16.Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality. Manual of Policies and Procedures (MAPP), Policy and Procedures, 5040.1, Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q). January 2017 17.Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: ANDA Submissions  Refuse-to-Receive Standards. December, 2016 18.Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: ANDA Submissions  Refuse to Receive for Lack of Justification of Impurity Limits. August 2016 19.Food and Drug Administration, Center for Drug Evaluation and Research (CDER), and Center for Veterinary Medicine (CVM). Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. November 1994 20.Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Guidance for Industry: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products. June 2015 21.Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and Center for Veterinary Medicine. Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products. February 2008 22.Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: Changes to an Approved NDA or ANDA. April 2004 23.Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers. May 2014 24.USP <1207>0<1207.1>0<1207.2>0<1207.3> 25.European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). EMA/CHMP/QWP/799402/2011: Reflection Paper on the Pharmaceutical Development of Intravenous Medicinal Products Containing Active Substances Solubilised in Micellar Systems. 26.European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on the Investigation of Bioequivalence. January 2010 27.Health Canada, Health Products and Food Branch. GUIDANCE FOR INDUSTRY: Pharmaceutical Quality of Aqueous Solutions. February 2008 28.Food and Drug Administration, Center for Drug Evaluation andResearch (CDER). GuidancesDrugs Generics: https:// www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064995.htm 29.Food and Drug Administration, Center for Drug Evaluation andResearch (CDER). Generic Drug Development: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm142112.htm 30.Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Office of Generic Drugs. Filing Review of Abbreviated New Drug Applications, MAPP 5200.14. September 2017. 31.European Medicines Agency, Committee for Proprietary Medicine Products. Note for Guidance on In-use Stability Testing of Human Medicine Products. September 2001. 32.European Medicines Agency, Committee for Proprietary Medicine Products. Note for Guidance on Inclusion of Antioxidants and Antimicrobial Preservatives in Medicine Products. January 1998.   PAGE \* MERGEFORMAT2   PAGE \* MERGEFORMAT19    (*<>LNPT\^& ( f h Ƽ|pf\UMF? 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