Results

Session 9: Quality Management and Prequalification Session Objectives • Place international standards within quality management context • Discuss intent and scope of key quality management…

Session 10: The UNFPA Prequalification Site Inspection Group Brainstorm: Site Inspection • In your experience, in what areas have you disagreed with the inspectors? Objectives • Provide overview…

Session 1: Changing Trends in Supply and Demand for Reproductive Health Supplies Projected Need • Need for reproductive health (RH) supplies is increasing at a rapid rate • Financing comes from…

Session 2: Overview of the WHO Prequalification Programme Prequalification • In principal: A documented process for reviewing a product or service to ensure it complies with identified criteria WHO…

Session 3: Common Quality Assurance Problems Physical Defects Photo: PATH Counterfeit Product Photo: FDA Active Ingredients 5 Photo: PATH Other Ingredients Photo: PATH Photo: Lisa Hedman,…

Session 4: Ensuring Product Quality Throughout the Supply Chain Potential Quality Assurance Checkpoints Within the Overall Supply Chain 1. Raw Materials / Components 2. Manufacturing 3.…

Session 5: Increase in Use of the WHO Prequalification Programme Perceived Need for Prequalification In an ideal world: • Regulated pharmacies and service providers would supply medicines to…

Session 6: WHO Prequalification Programme Key Process Steps WHO: Medicines UNFPA: Condoms and IUDs Session adapted from the WHO training workshop on prequalification and the WHO technical briefing…

World Health Organization The Prequalification Programme created by WHO undertakes comprehensive evaluation of the quality, safety, and efficacy of reproductive health medicines, based on: •…

Session 8: Quality Assurance of Products Not Listed Under the WHO Prequalification Programme Question for Participants How do we ensure the quality and integrity of a product that has not been…