Update on WHO Prequalification of QCLs and Quality Monitoring Projects Jitka Sabartova WHO Prequalification of Medicines Programme

Prequalification of QC laboratories Objectives Increase the access to services of QCLs that Meet recommended standards for testing of medicines, and Are committed to test medicines for UN agencies Contribute to capacity building of national QCLs in developing countries (strengthening of health systems) Technical assistance Trainings Guidelines 2

QCLs Prequalification Procedure (1) Established in 2004 - for QC laboratories in Africa only Procedure adopted by the WHO Expert Committee www.who.int/prequal/info_general/documents/TRS961/TRS961_Annex12.pdf Scope - chemical and microbiological testing (including LAL test) of medicines Participation of a QC laboratory is voluntary Any laboratory (private or governmental) can participate Free of charge Based on the following principles Evaluation of information submitted by the laboratory On site inspection Monitoring of performance of prequalified laboratory Regular members know this well, but as there are always some completely new members, I am including this basic information.

QCLs Prequalification Procedure (2) Site inspection Compliance with WHO recommended standards WHO Good Practices for Pharmaceutical Quality Control Laboratories www.who.int/prequal/info_general/documents/TRS957/GPCL_TRS957_Annex1.pdf WHO Good manufacturing practices – parts relevant to QCLs www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html 3rd Invitation for Expression of Interest - September 2007 www.who.int/prequal/info_applicants/eoi/EOI-QCLabsV3.pdf Without regional limitation 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

QCLs Prequalification Procedure (3) List of prequalified laboratories and WHOPIRs published www.who.int/prequal Monitoring after prequalification Re-inspections at a frequency based on risk assessment At least once every 3 years Evaluation of results from participation in proficiency testing Brief report requested to be submitted annually Summary of services provided to UN agencies, number of analysed samples, methods used, complaints received Changes with significant impact to the laboratory (key personnel, facility, equipment) and update LIF WHO may suspend or withdraw a laboratory from the list when there is evidence of noncompliance 5

www.who.int/prequal 6

www.who.int/prequal

Prequalified / interested laboratories (1) October 2011 25/04/2019 Prequalified / interested laboratories (1) October 2011 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) TFDA, Tanzania (2011) SGS, India (2011) SGS, Belgium (2011) Proxy, Netherlands (2011) INFARMED, Portugal (2011) FUNED, Brazil (2011) 8 8

Prequalified / interested laboratories (2) October 2011 25/04/2019 Prequalified / interested laboratories (2) October 2011 9 9

25/04/2019 Inspections / Pre-audits performed within QCL prequalification procedure 10 10

Capacity building Technical assistance provided to national medicines QCLs 17 since 2006 (5 in 2011) Focus on implementation of quality system, microbiology testing Training Seminar on quality management system in QCL (November 2010) South Africa, 46 participants from 27 countries (AFRO, AMRO, EMRO, EURO, WPRO) Training in dissolution and water determination (organized with AFSSAPS and EDQM in September 2011) Senegal, 20 participants from 10 countries (AFRO, EMRO) Training for microbiological laboratories (November 2011) Jordan, 34 participants from 27 countries (AFRO, AMRO, EMRO, EURO, WPRO) External Quality Assessment Scheme for National Drug Quality Control Laboratories 11

Potential benefits of WHO prequalification 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 national QCLs, possibility to be assisted by WHO expert consultants and participate in WHO organized trainings

WHO-Prequalification Programme Quality Monitoring Projects Objectives Monitor quality of medicines procured by UN agencies/ prequalified products Contribute to quality control of medicines, if requested by MSs Contribute to capacity building by cooperation with MRAs (strengthening of health systems) Sampling and testing projects – a tool Importance of reliability of quality control laboratories used Prequalified laboratories, if available If not, laboratories for which the evidence of reliability is available

www.who.int/prequal

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 market and screened by Minilab 306 tested in laboratory according to Ph.Int., USP or laboratory method This is just a basic information and I will give to Wendy reports for all the participants. You can just refer them to this very extensive report.  Even if any deviation from specifications is wrong, there is always a question, how serious the failures were. Therefore we defined for the purpose of these survey "extreme deviation" – more than 20% from the declared content or dissolution more than 25% lower than pharmacopoeial Q value. 12% samples were extremely deviating including 2 samples not containing the APIs. Good performance of PQed products. 2 groups of countries – Ethiopia with no failure and Kenya and Tanzania with relatively low failure rates on one side and Cameroon, Ghana and Nigeria with very worrying results. Failure for PQed products 4% Failure for non PQed products 40%

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

Thanks for your attention prequallaboratories@who.int www.who.int/prequal 17