1. The PAHO Prequalification System External Quality Control Program of Official Drug Quality Control Laboratories (EQCP) José M. Parisi PAHO/WHO Costa Rica Meeting, November 8, 2005

2. Costa Rica 20052 The PAHO Prequalification System Set up in 2000 Objective: to assure the quality of medicines purchased by PAHO on behalf of the Member States. Useful tool : for the Member States purchasing medicines by themselves or through PAHO in compliance with WHO recommended procedures How it works: Any supplier or manufacturer wishing to participate at the bidder process, have to be included in the prequalified supplier list.

3. Costa Rica 20053 Criteria in the Source Selection of Product: 2 groups 1) For single or limited-source pharmaceuticals including HIV/AIDS antiretroviral (innovator products, manufactured /registered in USA, EU) 2) Multi-source products (generic). manufacturers and distributors  CPF (Company Profile Form)  Evidence of having been evaluated, by an International Organization when appropriate  Questionnaire including:  Site Master File  GMP certificate  Marketing Authorization of Pharmaceutical Products with special Reference to Multisource  Batch certificate, when the product is shipped

4. Costa Rica 20054 Procedure Steps of the Procedure 1. Invitation for pre-qualification 2. Receiving submissions (dossiers) 3. Screening of dossiers and dossier evaluation 4. Site inspection (in the region) 5. Pre-qualification results

5. Costa Rica 20055 Product Quality Control  At the origin  Statement of Licensing Status of Pharmaceutical Product  Certificate of Pharmaceutical Product  Batch certificate of Pharmaceutical Product  In the recipient countries  Batch certificate.  Quality testing at the Official Lab. of drug quality control

6. Costa Rica 20056 Achievements List of prequalified manufacturers and suppliers (Oct 2005)  65 manufacturers and 8 secondary suppliers  59 manufacturers evaluated not pre-qualified Network of Drug Quality Control Laboratories

7. Costa Rica 20057 Network of Drug QC Laboratories  A network of Official Drug Q.C. Laboratories has been established since 2000, with the assistance of the USP (U.S. Pharmacopeia)  to improve the performance of laboratories  to harmonize methodologies  to increase communication to promote the quality surveillance of pharmaceutical markets External Quality Control Program (EQCP)

8. Costa Rica 20058 The EQCP is composed of three Phases PHASE I Diagnostic study of the laboratories PHASE II Performance evaluation PHASE III Training of human resources

9. Costa Rica 20059 Phase I: 23 Official Drug QC Lab. From 21 countries Phase II: 5 steps of performance evaluation with: Acetyl salicylic acid Ibuprofen Acyclovir Acetaminophen Streptomycin Zidovudine Phase III: 5 training workshops in HPLC and Disolution test with Zidovudine, Lamivudine, Quinine, Mefloquine, and Artesunate, in: Guatemala and Central America countries Panama and the Caribean countries Ecuador and the Andean countries Bolivia and the Amazonic countries Guyana