1.7 This document should be read in conjunction with other WHO guidelines as referenced below (2-14), as well as other regulatory guidelines which include The International Council for Harmonisation of Technical Requirements for Pharmaceutical...
Stabilitytestingofactivepharmaceuticalingredientsandfinishedpharmaceuticalproducts WHO StabilityTestingofActivePharmaceuticalIngredients APIs andFinishedPharmaceuticalProducts FPPs Q1A StabilityTestingofNewDrugSubstancesandProducts 主要内容 1 Introduction 1 1Objectivesoftheseguidelines 为药物活性成分和制剂成品申报所需的稳定性...
1.1. In view of an old publication date,and the recent need for new guidelines arising from inspections carried out forCOVID-19 therapeutics, the World Health Organization (WHO) PrequalificationTeam-Inspection Services (PQT INS) raisedthe urgency for a revision of the WHO Good manufacturing practi...
3.7.4 Active pharmaceutical 3.7.4 Active pharmaceutical ingredients intended for storage b 36、elow ingredients intended for storage below -20-20 C C 具体情况具体分析。3.8 Stability commitment 如果在获得批准时,长期稳定性数据没有覆盖拟定的复测期,应承诺在批准后继续进行稳定性试验以确认复测期或货架期...
WHO-附录3疫苗稳定性评价指导原则Guidelines on stability evaluation of vaccines 热度: WHO/IVB/06.10ORIGINAL:ENGLISH Temperaturesensitivityofvaccines Immunization,VaccinesandBiologicals TheDepartmentofImmunization,VaccinesandBiologicalsthanksthedonorswhoseunspecifiedfinancialsupporthasmadetheproductionofthisdocumentpossible. ...
API Active pharmaceutical ingredient (活性药物成分)BCS Biopharmaceutics Classification Scheme (生物药学分类系统)BCS #1 Biopharmaceutics class number 1(the most favourable) (生物药学分类系统第一类)（最有利的一类） CHMP Committee for Medicinal Products for Human Use; see also CPMP (人用医疗...
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 Foraregistrationapplicationwithinthe threeregionsoftheEC,Japan,andthe UnitedStates.Itdoesnotseeknecessarilyto coverthetestingforregistrationinorexport ...
conditions as identifi ed by WHO Member States. Appendix 2 Examples of testing parameters… Appendix 3 Recommended labelling statements… 87 1. Introduction 1.1 Objectives of these guidelines These guidelines seek to exemplify the core stability data package required for registration of active ...
•Q1A——StabilityTestingofNewDrugSubstancesandProducts 主要内容 1 •Introduction•FinishedPharmaceuticalProducts(FPPs)2 3 •ActivePharmaceuticalIngredients(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。ICHQ1AForaregistrationapplicationwithin...
WHO-附录3疫苗稳定性评价指导原则Guidelines on stability evaluation of vaccines.pdf,Annex 3 Guidelines on stability evaluation of vaccines 1. Introduction 175 2. Scopes 176 3. Glossary 177 4. General considerations 179 5. Stability evaluation at different