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Prequalification of Quality Control Laboratories WHO Quality Monitoring

Jitka Sabartova WHO Prequalification of Medicines Programme WHO/UNICEF Technical Briefing Seminar 1 Nov 2012, Geneva. Prequalification of Quality Control Laboratories WHO Quality Monitoring. QCLs Prequalification Procedure. Established in 2004 in cooperation with UN agencies

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Prequalification of Quality Control Laboratories WHO Quality Monitoring

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  1. Jitka Sabartova WHO Prequalification of Medicines Programme WHO/UNICEF Technical Briefing Seminar 1 Nov 2012, Geneva Prequalification of Quality Control LaboratoriesWHO Quality Monitoring

  2. QCLs Prequalification Procedure • Established in 2004 in cooperation with UN agencies • Initially limited to QC laboratories in Africa • 3rd EOI published in September 2007, without regional limits • 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 • Currently free of charge • Scope - chemical and microbiological testing (including LAL test) of medicines (vaccines, biologicals not included) • Priority in the assessment is given to • National QC laboratories and laboratories providing testing services to the governments • QC laboratories in areas where UN agencies identify the need for quality testing

  3. Prequalified / interested laboratories(September 2012) 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, TÜV (2009) • Canada, K.A.B.S. Laboratories (2010) • Ukraine, CLQCM (2010) • Ukraine, LPA (2010) • Peru, CNCC (2010) • Uruguay, CCCM (2010) • Bolivia CONCAMYT (2010) • Tanzania, TFDA (2011) • India, SGS (2011) • Belgium, SGS (2011) • Netherlands, Proxy (2011) • Portugal, INFARMED (2011) • Brazil, FUNED (2011) • Russia, FSBI-SCEEMP (2012) • Belarus, RCAL (2012)

  4. QCLs in the procedure (September 2012)

  5. www.who.int/prequal

  6. www.who.int/prequal

  7. Capacity building • Technical assistance provided to national medicines QCLs in developing countries • 18 since 2006 (6 in 2011, 4 in 2012) • Focus on implementation of quality system, microbiology testing • Training • Training in dissolution and water determination(organized with AFSSAPS and EDQM in September 2011, Senegal) • Training for microbiological laboratories (November 2011, Jordan) • Workshops on laboratory quality control of reproductive health products (organized with UNFPA in November-December 2011 - Tanzania and Namibia; February 2012 – Ghana; November 2012 – Thailand) • External Quality Assessment Scheme for National Drug Quality Control Laboratories

  8. Potential benefits of PQ for QCLs • Possibility to provide testing services to UN agencies and other organizations - financial profit • Recognition as being WHO listed laboratory • Facilitated discussions with manufacturers/customers in case of non-compliant results • Learning process improving the standards of laboratory work • In case on a national QCLs in a developing country, possibility to be assisted by WHO expert consultants and participate in WHO organized trainings

  9. www.who.int/prequal

  10. Quality survey of antimalarials in Africa • Cooperation with NDRAs in Cameroon, Ethiopia, Ghana, Kenya, Nigeria, Tanzania • ACTs and sulfadoxine-pyrimethamine • 935 samples collected at all distribution levels including informal marketand screened by Minilab • 306 tested in laboratory according to Ph.Int., USP or laboratory method • Failure for PQed products 4% • Failure for non PQed products 40%

  11. Quality survey of anti-TB medicines in NIS • Cooperation with NDRAs in Armenia, Azerbaijan, Belarus, Kazakhstan, Ukraine, Uzbekistan • Rifampicin, Isoniazid, Rifampicin/Isoniazid, Ofloxacin, Kanamycin • 291 samples collected at hospitals, dispensaries, pharmacies and tested according to Ph.Int. or USP • None of 38 samples of WHO-prequalified products failed

  12. What should be kept in mind when organizing testing of procured medicines • Considerations on necessity/frequency of testing based on risk evaluation • GMP compliance of the manufacturer, product prequalified or registered by SRA • Specifications for testing should be agreed with the supplier in advance • Manufacturer's specifications (with method transfer by the lab) or a pharmacopoeia monograph • Testing performed by a reliable laboratory • Out-of-specification results investigated by the lab • Discussion with the manufacturer • PQP should be informed about problems with PQed products

  13. Thanks for your attention sabartovaj@who.int prequallaboratories@who.int www.who.int/prequal

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