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José M. Parisi PAHO/WHO

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.

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José M. Parisi PAHO/WHO

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

  2. The PAHO Prequalification System • Set upin 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 2005

  3. Criteria in the Source Selection of Product: 2 groups • For single or limited-source pharmaceuticals including HIV/AIDS antiretroviral (innovator products, manufactured /registered in USA, EU) • 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 2005

  4. 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 2005

  5. 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 2005

  6. 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 2005

  7. 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 2005

  8. The EQCP is composed of three Phases PHASE I Diagnostic study of the laboratories PHASE II Performanceevaluation PHASE III Training of human resources Costa Rica 2005

  9. 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 Costa Rica 2005

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