STABILITY TESTING OF ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED PHARMACEUTICAL PRODUCTS WHOStability Testing of Acti
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...
1.7 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 Pharmaceuticals for Human Use (ICH) Q7, Q8, Q9, Q10 and Q11. This ...
《WHO制药生产技术转移指南( WHO guidelines on the transfer of technologyin pharmaceutical manufacturing)》,该指南解读及全文翻译如下: 1、要求转移方和接收方都应该有一个适当设计、明确定义和书面的质量体系。质量体系应具备足够的资源,充分实施和维护。 2、要求质量体系应包含GxP,不单单是GMP。 3、应保留技术...
•WHO——StabilityTestingofActivePharmaceuticalIngredients(APIs)andFinishedPharmaceuticalProducts(FPPs)•Q1A——StabilityTestingofNewDrugSubstancesandProducts 主要内容 1 •Introduction•FinishedPharmaceuticalProducts(FPPs)2 3 •ActivePharmaceuticalIngredients(APIs)1.INTRODUCTION 1.1Objectivesoftheseguidelines ...
StabilityBackground & Objective: Accelerated stability study (40掳C/75% RH, 6 months) as well as long term stability studies (30掳C/65% RH, 36 months) are conducted on three batches (I-III) of two commercially available CNS active herbal products (A and B) containing Convolvulus pluri...
Early in the development process the manufacturer is encouraged to discuss with the national regulatory authority these approaches for the study 1 design and data analysis and their suitability for the product in question. 1 0 2 In developing this document, guidelines for stability evaluation of , ...
In addition, the WHO guidelines for nonclinical and clinical evaluation of vaccines, stress a need for stability data to support approval of a clinical trial (1, 2). However, until now there has been no comprehensive guidance document available which deals with the evaluation of the stability ...
WHO稳定性试验指南.pptx,Stability testing of active pharmaceutical ingredients and finished pharmaceutical products;;主要内容 ;1. Introduction ;1.1 Objectives of these guidelines;1.2 Scope of these guidelines;1.3 General principles;;;主要内容 ;2. Finished