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

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
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)
29/05/2019
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) 3 3

4. 29/05/2019
QCLs in the procedure
(September 2012) 4 4

5.
WHO Expert Committee, October 2011 5

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 Tanzania and Namibia; February 2012 – Ghana; November 2012 – Thailand)
External Quality Assessment Scheme for National Drug Quality Control Laboratories 7

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

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 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%

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