prequalification of quality control laboratories who quality monitoring projects
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Prequalification of Quality Control Laboratories WHO Quality Monitoring Projects. Tony Gould for Jitka Sabartova Prequalification of Medicines Programme WHO. QCLs Prequalification Procedure. Established in 2004 - for QC laboratories in Africa only - PowerPoint PPT PresentationTRANSCRIPT
Prequalification of Prequalification of Quality Control LaboratoriesQuality Control Laboratories
WHO Quality Monitoring ProjectsWHO Quality Monitoring Projects
Tony Gould for Jitka SabartovaPrequalification of Medicines Programme
WHO
Technical Briefing Seminar, 1-5 November 20102
QCLs Prequalification Procedure• Established in 2004 - for QC laboratories in Africa only
• 3rd Invitation for Expression of Interest published in September 2007
– Without regional limitation– http://www.who.int/prequal/info_applicants/eoi/EOI-QCLabsV3.pdf
• 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 20103
Prequalified / interested laboratories (1) (1) October 2010October 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)
83
10
3
16
3
22
8
24
11
29
17
29
0
5
10
15
20
25
30
35
40
45
50
2004 2005 2006 2007 2008 2009 Oct-10
QCLs Prequalified QCLs Interested
Technical Briefing Seminar, 1-5 November 20104
Monitoring the quality of medicinesMonitoring 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 20105
Quality survey of antimalarials(QAMSA - 2008/9)(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 20106
QAMSA - Failure rates by product
14
80
18
19
9
33
86
2
6
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
AL A&A co-p AA FDC SP SPP
No of non-compliant samples No of compliant samples
Technical Briefing Seminar, 1-5 November 20107
7312
1
17
80
111
68
12
12
7
3 20%
20%
40%
60%
80%
100%
PQ total Non-PQtotal
AL PQ AL non-PQ A&A co-pPQ
A&A co-pnon-PQ
Non-compliant Compliant
QAMSA - comparison of failure rates of prequalified and non-prequalified products
AL: arthemether/ lumefantrine
AA: artesunate/ amodiaquine
Technical Briefing Seminar, 1-5 November 20108
Thanks for Thanks for your attentionyour attention
www.who.int/prequal