1. Prequalification of Quality Control Laboratories WHO Quality Monitoring Projects
Tony Gould for Jitka Sabartova
Prequalification of Medicines Programme
WHO
WHO Expert Committee on Specifications, Oct 2010

2. QCLs Prequalification Procedure
Established in for QC laboratories in Africa only
3rd Invitation for Expression of Interest published in September 2007
Without regional limitation
Participation of a QC laboratory is voluntary
Any laboratory (private or governmental) can participate
Free of charge
Published list of prequalified laboratories
The list may be used by any organization to ensure that testing for quality monitoring is done at an acceptable standard
Technical Briefing Seminar, 1-5 November 2010
WHO Expert Committee on Specifications, Oct 2010

3. Prequalified / interested laboratories (1) October 2010
23/04/2019
Prequalified / interested laboratories (1) October 2010
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)
Technical Briefing Seminar, 1-5 November 2010
WHO Expert Committee on Specifications, Oct 2010 3

4. Monitoring the quality of medicines
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
Planned and implemented according to protocols
WHO prequalified laboratories used, if possible
Technical Briefing Seminar, 1-5 November 2010

5. Quality survey of antimalarials (QAMSA - 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
By NDRAs in cooperation of with WHO country offices
At all levels of distribution chain (private and public) and informal market, throughout the countries
Testing
935 samples collected and screened by GPHF-Minilab
306 selected for testing in QC laboratory (RIIP, South Africa; USP laboratory) according to Ph.Int., USP, laboratory in-house method
Technical Briefing Seminar, 1-5 November 2010
WHO Expert Committee on Specifications, Oct 2010

6. QAMSA - Failure rates by product
Technical Briefing Seminar, 1-5 November 2010
WHO Expert Committee on Specifications, Oct 2010

7. QAMSA - comparison of failure rates of prequalified and non-prequalified products
AL: arthemether/
lumefantrine
AA: artesunate/
amodiaquine
Technical Briefing Seminar, 1-5 November 2010
WHO Expert Committee on Specifications, Oct 2010

8. Thanks for your attention
Technical Briefing Seminar, 1-5 November 2010
WHO Expert Committee on Specifications, Oct 2010