the stability report requirements for：稳定性报告要求

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1、FilecontentofStabilityStudy(محتوياتملفدراسةالثبات)FilecontentincaseofstabilitystudyofOLDSYSTEM1-Coveringletterofthefilecontents.2-Copyofcomposition.3-Methodofanalysisforstabilityforfinishedproducts.4-CopyofcertificateofanalysisfromNODCAR.5-Completestabilityre

2、portwithtablesfor3batches(acceleratedorlongterm).6-Copyfromcertificateofanalysisfromcompany.7-ChromatogramsofHPLCanalysisofeachtimeintervalforallbatches(atleastforlasttimeinterval)8-MethodofvalidationofAnalyticalproceduresforfinishedproductwiththeHPLCChartsfo

3、reachparameter.9-صورةمنالموافقةعلىالسيرفيإجراءاتالتسجيل.InCaseofRe-registration:addthefollowingitems:صورةمنإخطارالتسجيلفيحالةإعادةالتسجيل--Documentfromongoingstabilitystudiesforatleastonebatch/yearforsurveillanceperiod(shelfperiod).-Originalpackwiththeshelfli

4、fe&storageconditionsInCaseofImportedProducts:addthefollowingitems:-CopyfromtheSourceCPPconfirmstheShelflife&storageconditions(shelflifeinthecountryoforigin..)-Originalpackwiththeshelflife&storageconditionsFilecontentincaseofstabilitystudyofNEWSYSTEM(firstrepr

5、esentation)1-Coveringletterofthefilecontents.2-Copyofcomposition(oncompanypaper)3-Methodofanalysisforstabilityforfinishedproducts.4-Acceleratedstabilitystudyonone(R&Dbatch)atleastforfourtimeintervals.5-Copyfromcertificateofanalysisfromcompany.6-Chromatogramso

6、fHPLCanalysisofeachtimeinterval.7-MethodofvalidationofAnalyticalproceduresforfinishedproductwiththeHPLCChartsforeachparameter.8-صورةمنالموافقةعلىالسيرفيإجراءاتالتسجيل.9--WHOformatonthecompanypaper(stamped).10-Arabic&Englishleaflet+reference11-Coloredpack+pack

7、oftheinnovator.12-Copyofapplication.13-Copyofpricingcommitteeapproval.(secondrepresentation)1-Coveringletterofthefilecontents.2-Copyofcomposition(oncompanypaper)3-Methodofanalysisforstabilityforfinishedproducts.4-Acceleratedstabilitystudyonone(Productionbatch

8、)atleastforfourtimeintervals.5-Copyfromcertificateofanalysisfromcompany.6-ChromatogramsofHPLCanalysisofeachtimeinterval.7-MethodofvalidationofAnalyticalproceduresforfinishedproductwiththe