E-DRUG: New Phase in WHO's Quality Control Laboratory Scheme
Quality of medicines is a major public health challenge, particularly in light
of the cross-border health-related issues and the international dimensions of
trade. Quality assurance is a wide-ranging concept that helps to ensure that
quality medicines reach the patient; it covers all matters that individually or
collectively influence the quality of a product. Quality control has
traditionally been one of the key elements in quality assurance and therefore
pharmaceutical quality control laboratories play a major role in protecting
Quality control (QC) testing is complex, and errors are costly and may
jeopardize patient safety. Patients may receive ineffective or even harmful
medicines; if genuine quality deficiencies are not identified, conversely, if
non-conforming results are falsely interpreted as quality failures, expensive
medicines may be returned or destroyed, potentially leaving patients without
life-saving treatment until the products are replaced at sometimes enormous
additional cost. Given these high stakes, trust in a QC laboratory's
capabilities is essential for all stakeholders who request its services.
WHO is pleased to announce Phase 6 of its External Quality Assurance Assessment
Scheme (EQAAS) at preferential fees far below cost for participants from lower-
and middle-income countries. In order to enhance the efficiency and save costs,
for each shipment two studies will be carried out. Fees are based on the World
Bank classification of income. The cost per shipment for two studies is as
- Laboratories from low-income countries: US$ 1000
- Laboratories from middle-income countries: US$ 2000
- Laboratories from high-income countries: US$ 4000
The fee covers shipment of the two test samples together with the study
protocols and the subsequent statistical evaluation of the submitted results.
WHO informs the laboratories about their performance and provides additional
guidance for improving their capabilities. The scheme is set out in close
cooperation with related WHO programmes, including the programme dealing with
the prequalification of QC laboratories.
International donors may be approached for funding of participation in the
EQAAS. The Global Fund to Fight AIDS, Tuberculosis and Malaria encourages grant
applicants to include this item in their applications for funding. The Global
Fund requires grant recipients to arrange for systematic random QC testing of
products throughout the in-country supply chain for medicines worth
approximately USD 600 million delivered to grant-funded programmes every year.
It also funds large quantities of laboratory equipment and reagents. Other
donors have similar policies.
WHO invites laboratories to participate in EQAAS Phase 6 studies. To ensure
continued assistance to laboratories in Member States, WHO will offer advice on
possible funding sources through WHO country projects for laboratories in
developing countries that have no means to recuperate the fee, and for whom the
fee presents an obstacle for participation.
WHO at present offers the only global, independent scheme to measure
laboratories' QC testing capabilities. The EQAAS was established by WHO in
2000 at the request of the Global Fund as a mechanism to maximize health
benefits achieved on grant investments in pharmaceuticals and laboratory
supplies. The EQAAS has proven to be a major asset to WHO Member States. More
than 60 laboratories across WHO's six regions, many of them in Africa, have
participated in the past comparative external assessment studies. Participation
in such studies is mandatory according to WHO's good practices for
pharmaceutical quality control laboratories and for ISO 17025 accreditation.
For more information and expression of interest to participate in this new
phase in WHO's QC laboratory scheme, please contact WHO at the following
email: EQAAS@who.int .
Dr Sabine Kopp
Group Lead, Medicines Quality Assurance
Technologies Standards and Norms
Regulation of Medicines and Other Health Technologies
World Health Organization
"KOPP, Sabine" <email@example.com>