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Quality Assurance of Reproductive Health Commodities RHSC, SSWG, Addis Ababa, June 2011

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. Role of Quality Assurance in Reproductive Health Commodity Security

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Quality Assurance of Reproductive Health Commodities RHSC, SSWG, Addis Ababa, June 2011

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  1. Quality Assurance of Reproductive Health Commodities RHSC, SSWG, Addis Ababa, June 2011 Morten Sorensen, Deputy Chief, Procurement Services Branch, Copenhagen

  2. Enhancing the commodity security of RH products • Role of Quality Assurance in Reproductive Health Commodity Security • Implement quality assurance processes and procedures that support procurement • Increase access to quality assured products and manufacturers that meet internationally recognized and specified quality standards and requirements • Adopt appropriate risk management strategies to enhance availability of quality assured products

  3. Quality Assurance system

  4. Quality Assurance Policy for RH Medicines • Strengthening QA systems & procedures • Developed a QA policy for RH medicines • Limited number of prequalified RH products and lack of risk management strategies • The need to adopt QA processes to minimize quality risks • Continue collaboration with key partners (WHO & other UN agencies) to implement the QA strategies

  5. Prequalification of male condoms & IUDs • Prequalification Programme • Prequalified 26 male condom factories • 8 IUD factories • Heavy on financial & human resources • Collaboration with partners and relevant stakeholders has been instrumental

  6. New developments for Female Condoms • New product designs • Various stages of development • Different materials • Varying features: • Insertion • Retention • Generic specifications, prequalification & procurement guidelines • ISO standard

  7. Supporting national systems • Capacity Building including effective partnerships & collaborations • Quality Control Laboratories - Trained 21 countries in the Latin America & Caribbean region on quality control laboratory testing standards for RH commodities • Inconsistent quality testing methods and unclear regulatory requirements • Promote adoption of international standards & WHO/UNFPA guidelines and the harmonization of testing procedures and laboratory management; clarity on regulatory and registration requirements • Include 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 condoms • CD-rom (all publications in one)

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