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Prequalification of Quality Control Laboratories WHO Quality Monitoring Projects

Prequalification of Quality Control Laboratories WHO Quality Monitoring Projects. Jitka Sabartova Prequalification Programme: Priority Essential Medicines HSS/EMP/QSM. Prequalification of QC laboratories. Need to increase the access to QC laboratories that

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Prequalification of Quality Control Laboratories WHO Quality Monitoring Projects

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  1. Prequalification of Quality Control Laboratories WHO Quality Monitoring Projects Jitka Sabartova Prequalification Programme: Priority Essential Medicines HSS/EMP/QSM

  2. Prequalification of QC laboratories • Need to increase the access to QC laboratories that • meet recommended standards for testing of medicines • are committed to provide a service of testing of medicines, including but not limited to HIV/AIDS, Tuberculosis and Malaria products to UN agencies • Procedure established in 2004 for QC laboratories in Africa • In cooperation with UNICEF, UN Population Fund (UNFPA), UNAIDS and with the support of the World Bank • UNITAID and The Global Fund - partners

  3. QCLs Prequalification Procedure • Participation of a QC laboratory is voluntary • Any laboratory (private or governmental) can participate • Free of charge • 3rd Invitation for Expression of Interest published in September 2007 • Without regional limitation • http://www.who.int/prequal/info_applicants/eoi/EOI-QCLabsV3.pdf • Priority in the assessment is given to • National QC laboratories and laboratories providing testing services to the government • QC laboratories in areas where UN agencies identify the need for quality testing

  4. Based on the following principles • General understanding of the quality control activities of the laboratory • Evaluation of information submitted by the laboratory • Assessment of consistency in quality control through compliance with WHO standards • Inspection of the quality system implemented by the laboratory

  5. QCLs Prequalification Procedure (1)September 2009 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)

  6. QCLs Prequalification Procedure(2)September 2009

  7. Inspections / Pre-audits performed

  8. www.who.int/prequal

  9. Monitoring after prequalification • Re-inspections at regular intervals • Normally 3 years • 2 re-inspections performed • Brief report to be submitted annually • Summary of services provided to UN agencies, number of analysed samples, methods used, complaints received • Brief details of proficiency testing • Changes to key personnel, facility, equipment or other significant impact to the laboratory • Update of LIF, in case of changes with significant impact on LIF content • Evaluation of results from participation in proficiency testing • WHO External Quality Assurance Scheme, AFSSAPS network of Francophone African countries • WHO may suspend or withdraw a laboratory from the list when there is evidence of noncompliance

  10. Participation in WHOExternal Quality Assurance Scheme (1) • Non-commercial laboratories involved in prequalification procedure were invited • WHO - Phase 4, 06/2007 - 01/2009 • Water content by Karl Fischer(Oxytetracycline dihydrate) • 3 of 10 labs unacceptable results • Dissolution testing(Isoniazid tablets, UV) • 2 of 18 labs unacceptable results • HPLC assay(zidovudine/lamivudine FDC) • 2 of 18 labs unacceptable results for both assays • Titration(quinine dihydrochloride injection) • 2 of 18 labs unacceptable results • Polarimetry(glucose) • 2 of 12 labs unacceptable results

  11. Capacity building • Technical assistance provided to 8 national medicines QC laboratories • Focus on implementation of quality system and microbiological testing, inventory audits • Trainings in Quality Assurance, Quality Control and Ph.Int. under preparation (2007) • Morocco, 44 participants from 16 Francophone countries (AFRO, EMRO), cooperation with EDQM and AFSSAPS • Tanzania, 46 participants from 23 Anglophone countries (AFRO, EMRO, PAHO/AMRO) • Seminar on rational sampling and testing in quality control of medicines (2009) • Kenya, 45 participants from 21 countries (AFRO, EMRO, WPRO) • Participation in EDQM Quality Assurance training for OMCLs • 2005, 5 participants from AFRO and EMRO • 2007, 12 participants from AFRO, EMRO and EURO

  12. WHO Prequalification Programmemonitoring of medicines quality 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 – a tool for fulfilling the policy Prequalified laboratories or laboratories for which the evidence of reliability is available

  13. Sampling and testing projects Entry information Quality concerns, complaints/defects, signals, inspections PQ procedures Plan +updates Actions Reports Inspections Assessment PhV Conduct of projects P1 P3 P2 …

  14. Quality monitoring projects (1) • Quality monitoring of medicines funded by UNITAID (2008/9) • Strengthening of quality control of medicines as close to patients as possible, in cooperation with NDRAs (capacity building) • Framework protocol supplemented by country specific sampling plans • Assessment product information compliance with national requirements (Labelling and PIL) • Pilot phase • Paediatric and second line ARVs (abacavir, didanosine, efavirenz, tenofovir, tenofovir/emtricitabine, lopinavir/ritonavir, lamivudine, stavudine, nevirapine, zidovudine, lamivudine/stavudine, lamivudine/zidovudine, lamivudine/stavudine/nevirapine) + co-trimoxazole • Kenya, Tanzania, Uganda and Zambia • Testing in MHRA (UK), AFSSAPS (France), NICPBP (China) • Pharmacopoeial specifications – Ph.Int., USP, IP, manufacturers' methods • 383 samples from 24 manufacturers, majority prequalified and registered in the country • 3 samples non-compliant, no critical failure

  15. Quality monitoring projects (2) • Quality survey of antimalarial medicines (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 • At all levels of distribution chain (private and public) and informal market, throughout the countries • 936 samples collected by NDRAs in cooperation with WHO country offices • Testing • Screening by GPHF-Minilab • 305 samples then tested in RIIP, South Africa / USP (Ph.Int., USP, laboratory in-house method) • 67 non-compliant samples, range of quality problems, including absence of API in 2 samples • Assessment of quality of product information (Labelling and PIL)

  16. Quality monitoring projects (3) • Quality survey of antituberculosis medicines (2009) • Eastern Europe and NIS • Countries with high multidrug-resistant TB and extensively drug-resistant TB • Armenia, Azerbaijan, Belarus, Kazakhstan, Ukraine, Uzbekistan • Close cooperation with NDRAs and WHO EURO regional office • First- and second-line anti-TB medicines to be collected close to patients • Rifampicin capsules, Isoniazid tablets and injection, Rifampicin/Isoniazid tablets • Kanamycin powder for injection, Ofloxacin tablets and solution for infusion • Testing in OMCLs of Austria and Luxembourg, in EDQM, SGS (Belgium) according to Ph.Int. / USP • Comparative dissolution study of Rifampicin capsules and Rifampicin/Isoniazid tablets at Goethe University, Germany • 360 samples planned to be collected

  17. Quality monitoring projects (5) • Comparative dissolution study of Coartem tablets (2007) • Artemether / lumefantrine innovator - problems with dissolution reported • 5 batches manufactured in different manufacturing sites and collected in Tanzania, tested in RIIP, South Africa • Dissolution profiles compared to the mean of all data  SIMILAR • Generic products containing nelfinavir (2007) • Triggered by Roche worldwide withdrawal of Viracept • Test on EMS/MMS impurity using Roche method • Samples of finished product from Cipla, Hetero, GPO Thailand and of API from Matrix, Hetero collected from manufacturers, as well as from markets, tested in Swissmedic • All samples ≤ 0.5 ppm • For the purposes of Ph.Int. monograph dissolution tested

  18. Testing • Testing on request from countries/UN agencies • Artesunate+Amodiaquine tablets (co-blistered), Guilin Pharmaceuticals, China – request from NGO in Indonesia • Diethylcarbamazine citrate tablets, Asian Pharmaceutical Company, Nepal – request from Ministry of Health in Nepal • Praziquantel tablets, Merck, Mexico – cooperation with WHO procurement and Neglected Tropical Diseases - Schistosomiasis control project • Artesunate tablets, Guilin Pharmaceuticals, China – request from WPRO • Miltefosin capsules, Popular Pharmaceuticals, Bangladesh - request from Ministry of Health in Bangladesh • Rifampicin capsules and Clofazimine capsules, Sandoz, India - cooperation with WHO procurement and Neglected Tropical Diseases – Leprosis elimination project

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

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