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

2. 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

3. QCLs Prequalification Procedure (1)
Established in for QC laboratories in Africa only
Procedure adopted by the WHO Expert Committee
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.

4. QCLs Prequalification Procedure (2)
Site inspection
Compliance with WHO recommended standards
WHO Good Practices for Pharmaceutical Quality Control Laboratories
WHO Good manufacturing practices – parts relevant to QCLs
3rd Invitation for Expression of Interest - September 2007
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

5. QCLs Prequalification Procedure (3)
List of prequalified laboratories and WHOPIRs published
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

6. 6

8. 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

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

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

11. 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

12. 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

13. 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

15. 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%

16. 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

17. Thanks for your attention 17