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

Costa Rica 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.

Costa Rica 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

Costa Rica 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

Costa Rica 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

Costa Rica 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

Costa Rica 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)

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

Costa Rica 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