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Prequalification of Quality Control Laboratories WHO Quality Monitoring Projects

Prequalification of Quality Control Laboratories WHO Quality Monitoring Projects. Tony Gould for Jitka Sabartova Prequalification of Medicines Programme WHO. QCLs Prequalification Procedure. Established in 2004 - for QC laboratories in Africa only

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Prequalification of Quality Control Laboratories WHO Quality Monitoring Projects

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  1. Prequalification of Quality Control LaboratoriesWHO Quality Monitoring Projects Tony Gould for Jitka Sabartova Prequalification of Medicines Programme WHO

  2. QCLs Prequalification Procedure • Established in 2004 - for QC laboratories in Africa only • 3rd Invitation for Expression of Interest published in September 2007 • Without regional limitation • http://www.who.int/prequal/info_applicants/eoi/EOI-QCLabsV3.pdf • Participation of a QC laboratory is voluntary • Any laboratory (private or governmental) can participate • Free of charge • Published list of prequalified laboratories • The list may be used by any organization to ensure that testing for quality monitoring is done at an acceptable standard Technical Briefing Seminar, 1-5 November 2010

  3. Prequalified / interested laboratories (1) October 2010 Prequalified QCLs: • South Africa, RIIP+CENQAM (2005) • Algeria, LNCPP (2005) • South Africa, Adcock Ingram (2007) • Morocco, LNCM (2008) • Kenya, NQCL (2008) • India, Vimta Labs (2008) • France, CHMP (2008) • Vietnam, NIDQC (2008) • Kenya, MEDS (2009) • Singapore, HSA (2009) • Singapore, TÜV (2009) • Canada, K.A.B.S. Laboratories (2010) • Ukraine, CLQCM (2010) • Ukraine, LPA (2010) • Peru, CNCC (2010) • Uruguay, CCCM (2010) • Bolivia CONCAMYT (2010) Technical Briefing Seminar, 1-5 November 2010

  4. Monitoring the quality of medicines • Policy • To monitor quality of medicines procured by UN agencies/ prequalified products • To contribute to quality control of medicines, if requested by Member States • To contribute to capacity building by cooperation with NDRAs • Sampling and testing projects • Planned and implemented according to protocols • WHO prequalified laboratories used, if possible Technical Briefing Seminar, 1-5 November 2010

  5. Quality survey of antimalarials(QAMSA - 2008/9) • ACTs (most sold and recommended by national guidelines), sulfadoxine-pyrimethamine, oral dosage forms • Artemether/lumefantrine, artesunate/amodiaquine (both co-blistered and FDCs), sulfadoxine/pyrimethamine, sulfamethoxypyrazine/pyrimethamine • In 6 African countries (Cameroon, Ethiopia, Ghana, Kenya, Nigeria, Tanzania) • Collection of samples • By NDRAs in cooperation of with WHO country offices • At all levels of distribution chain (private and public) and informal market, throughout the countries • Testing • 935 samples collected and screened by GPHF-Minilab • 306 selected for testing in QC laboratory (RIIP, South Africa; USP laboratory) according to Ph.Int., USP, laboratory in-house method Technical Briefing Seminar, 1-5 November 2010

  6. QAMSA - Failure rates by product Technical Briefing Seminar, 1-5 November 2010

  7. QAMSA - comparison of failure rates of prequalified and non-prequalified products AL: arthemether/ lumefantrine AA: artesunate/ amodiaquine Technical Briefing Seminar, 1-5 November 2010

  8. Thanks for your attention prequallaboratories@who.int www.who.int/prequal Technical Briefing Seminar, 1-5 November 2010

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