Prequalification of Quality Control Laboratories WHO Quality Monitoring Projects Tony Gould for Jitka Sabartova Prequalification of Medicines Programme WHO WHO Expert Committee on Specifications, 18-22 Oct 2010

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 WHO Expert Committee on Specifications, 18-22 Oct 2010

Prequalified / interested laboratories (1) October 2010 23/04/2019 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 WHO Expert Committee on Specifications, 18-22 Oct 2010 3

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

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 WHO Expert Committee on Specifications, 18-22 Oct 2010

QAMSA - Failure rates by product Technical Briefing Seminar, 1-5 November 2010 WHO Expert Committee on Specifications, 18-22 Oct 2010

QAMSA - comparison of failure rates of prequalified and non-prequalified products AL: arthemether/ lumefantrine AA: artesunate/ amodiaquine Technical Briefing Seminar, 1-5 November 2010 WHO Expert Committee on Specifications, 18-22 Oct 2010

Thanks for your attention prequallaboratories@who.int www.who.int/prequal Technical Briefing Seminar, 1-5 November 2010 WHO Expert Committee on Specifications, 18-22 Oct 2010