Quality Assurance of Reproductive Health Commodities RHSC SSWG Addis Ababa June 2011 Morten Sorensen Deputy Chief Procurement Services Branch Copenhagen Enhancing the commodity security of RH products ID: 1044674
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1. UNFPABecause everyone countsQuality Assurance of Reproductive Health CommoditiesRHSC, SSWG, Addis Ababa, June 2011Morten Sorensen, Deputy Chief, Procurement Services Branch, Copenhagen
2. Enhancing the commodity security of RH productsRole of Quality Assurance in Reproductive Health Commodity SecurityImplement quality assurance processes and procedures that support procurementIncrease access to quality assured products and manufacturers that meet internationally recognized and specified quality standards and requirementsAdopt appropriate risk management strategies to enhance availability of quality assured products
3. Quality Assurance systemUNFPABecause everyone counts
4. Quality Assurance Policy for RH MedicinesStrengthening QA systems & procedures Developed a QA policy for RH medicines Limited number of prequalified RH products and lack of risk management strategiesThe need to adopt QA processes to minimize quality risksContinue collaboration with key partners (WHO & other UN agencies) to implement the QA strategies
5. Prequalification of male condoms & IUDsPrequalification Programme Prequalified 26 male condom factories 8 IUD factoriesHeavy on financial & human resourcesCollaboration with partners and relevant stakeholders has been instrumentalUNFPABecause everyone counts
6. New developments for Female Condoms New product designs Various stages of development Different materials Varying features:InsertionRetention Generic specifications, prequalification & procurement guidelines ISO standard
7. Supporting national systemsCapacity Building including effective partnerships & collaborationsQuality Control Laboratories - Trained 21 countries in the Latin America & Caribbean region on quality control laboratory testing standards for RH commoditiesInconsistent quality testing methods and unclear regulatory requirementsPromote adoption of international standards & WHO/UNFPA guidelines and the harmonization of testing procedures and laboratory management; clarity on regulatory and registration requirementsInclude participation of National Medicines Regulatory Authorities and Ministry of Health to enhance availability & access to quality assured products.
8. Updated guidelines Male Latex Condom specifications, prequalification and procurement guidelines The TCu380A Intrauterine Contraceptive Device specifications, prequalification and procurement guidelines Statement on post-shipment testing of male condomsCD-rom (all publications in one)