Results

mSupply user guide Version 2 [20 May 2008] 2 Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . 5 About this user guide 5 About…

PPPPSS Organization of Eastern Caribbean States/Pharmaceutical Procurement Service (OECS/PPS) Guidelines on Essential Medicines List (EML)/Formulary Management OECS Pharmaceutical Procurement…

Session 1: Prequalification and Procurement Session Objectives • Discuss aims of the World Health Organization (WHO) Prequalification Programme • Explain the role of the United Nations Population…

Session 2: Overview of the WHO Prequalification Programme for Condoms Session Objectives • Introduce the key differences between the new and old WHO/UNFPA prequalification scheme • Understand the…

Session 3: Preparation of a Product Dossier for Condom Prequalification Session Objectives • Give overview of all necessary components of a Product Dossier • Identify key reference documents •…

Session 4: Preparation of a Site Master File (SMF) Summary for Condom Prequalification Session Objectives • Provide overview of all necessary components of a Site Master File (SMF) Summary •…

Session 5: ISO 4074, the WHO Specification, and Related Standards Session Objectives • Understand why ISO standards and the WHO specification are requirements for prequalification • Identify…

Session 6: Shelf Life Objectives • Review the ISO/WHO shelf life and stability requirements • Discuss problems of shelf life in the distribution chain • Discuss how to conduct real-time stability…

Session 7: Product Safety and Biocompatibility Issues Session Objectives • Understand safety and biocompatibility requirements for prequalification per the WHO Specification • Identify required…

Session 8: Sampling and Acceptable Quality Limits (AQL) Objectives • Understand what you can infer from sample testing • Understand how to choose a sample size and make inferences about the…