STABILITY TESTING OF ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED PHARMACEUTICAL PRODUCTS WHOStability Testing of Acti
WHOSuitabletestingconditionsforWHOMemberStatesbasedonclimaticdata.ICHQ1AThechoiceoftestconditionsisbasedonananalysisoftheeffectsofclimaticconditionsinthethreeregionsoftheEC,JapanandtheUnitedStates.ThisguidelineaddressesclimaticzonesIandII.Fourclimaticzones.Appendix1 主要内容 1 •Introduction•FinishedPharmaceutical...
Stability testing meets WHO guidelines.Introduces the stability and photostability chambers from Caron company. Features of the chambers.EBSCO_bspManufacturing Chemist
•Q1A——StabilityTestingofNewDrugSubstancesandProducts 主要内容 1•Introduction •Finished 2 Pharmaceutical Products(FPPs)•Active 3 Pharmaceutical Ingredients(APIs)1.INTRODUCTION 1.1Objectivesoftheseguidelines •为药物活性成分和制剂成品申报所需的稳定性试验数据提供例证。ICHQ1A Foraregistration...
1.8. This version of the guidelineprovides updated requirements and expectations reflecting current goodpractices (GxP) in the transfer of technology and replaces the previous versionpublished (1). 本版指南对要求和期望进行了更新,从而反映对技术转移的现行 GXP 要求,取代之前发布的版本。 2. Scope 范围...
7.ICH Draft Consensus Guideline. Pharmaceutical Quality System. Q10. Geneva, ICH Secretariat, 2008 (http://www.ich.org/LOB/media/MEDIA3917. pdf, last accessed 27 July 2010). ICH一致性指南草案:药物质量体系,Q10,日内瓦,ICH秘书处,2008(最后登录时间2010年7月27日) 8. ICH Harmonized Tripartite Gu...
humanuse associateddrug products ICHQ1A Thisguidelinedoesnotcurrentlyseektocover theinformationtobesubmittedforabbreviated orabridgedapplications,variations,clinicaltrial applications,etc. 1.3Generalprinciples •稳定性试验的目的:研究API或FPP的质量 在各种环境因素(如温度、湿度和光照等) 的影响下随时间变化的情况...
2.3 The guideline applies to all pharmaceutical dosage forms and may be adapted on a case-by- case basis by using risk management principles. Particular attention should be given to certain complex formulations such as, for example, sterile products and metered dose aerosols. ...
2.3 The guideline applies to all pharmaceutical dosage forms and may be adapted on a case-by- case basis by using risk management principles. Particular attention should be given to certain complex formulations such as, for example, st...
1.8 This version of the guideline provides updated requirements and expectations reflecting current good practices (GxP) in the transfer of technology and replaces the previous version published (1). 该指南版本提供了更新的要求和期望,反映了技术转移中的当前良好实践(GxP),并替代了先前发布的版本。 2....