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The Global Fund Quality Assurance Policy for Pharmaceutical Products. Dr Joelle Daviaud Senior Pharmaceutical Quality Assurance Officer Pharmaceutical Management Unit Global Fund.
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Policy for Pharmaceutical Products
Dr Joelle Daviaud
Senior Pharmaceutical Quality Assurance Officer
Pharmaceutical Management Unit Global Fund
Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme and/or participating in respective sampling and testing projects, Nairobi, Kenya, 23-25 September 2009
As a partnership between governments, civil society, the private sector and affected communities, the Global Fund represents an innovative approach to international health financing.
As a financing mechanism, The Global Fund's purpose is to attract, manage and disburse resources to fight AIDS, TB and malaria. We do not implement programs directly, relying instead on the knowledge of local experts.
The Global Fund is a financial institution, about 35 % of grant funds are for medicines and health products procurement.
The GF does not conduct any procurement activities for pharmaceutical products, PR are responsible for ensuring adherence to Global Fund QA/QC requirements
Objective of the Global Fund
“making a “sustainable and significant” contribution
to the achievement of the Millennium Development Goals”
Country Proposal is
approved for TGF Grant
PR prepares PSM Plan
specifying health products
and quantities to order
Plan is submitted
to TGF/LFA for
PR reconciles needs
and funds available
PR launches procurement process
funds to Principal Recipient (PR)
Suppliers submit bids
PR evaluates bids
and awards supply
PR places order for
drugs and monitors
and checks drugs,including Quality Monitoring
results to TGF
Authorized for use by Drug Regulatory Authority (DRA) in recipient country
2 or more A or B products Available?
ERP recommended Product available?
GF request an ad Hoc ERP committee to review eligible product
A or B Product
ERP Product shipment
Product unavailability definition:
Inability to supply sufficient quantity of product within 90 days from date of order
Standard Product questionnaire dossier( based on Inter Agency Questionnaire):
recommended products since 1 July 2009
All pharmaceutical products funded by GF are subject to the monitoring of product quality
The laboratory should have the technical capabilities :
Tested after notification submitted by Principal Recipient and approved by the Global Fund Secretariat
Items to be tested and reported:
100 % of lot tested passed the QC criteria
In case of non compliance, corrective measures applies
The Global Fund
Local Fund Agent
Contact for Enquiries: email: firstname.lastname@example.org