The PAHO Prequalification System External Quality Control Program

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 2005

The PAHO Prequalification System n Set up in 2000 n Objective: to assure the quality of medicines purchased by PAHO on behalf of the Member States. n Useful tool: for the Member States purchasing medicines by themselves or through PAHO in compliance with WHO recommended procedures n 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 2

Criteria in the Source Selection of Product: 2 groups 1) 2) For single or limited-source pharmaceuticals including HIV/AIDS antiretroviral (innovator products, manufactured /registered in USA, EU) Multi-source products (generic). manufacturers and distributors Ø Ø CPF (Company Profile Form) Evidence of having been evaluated, by an International Organization when appropriate Questionnaire including: Ø Site Master File Ø GMP certificate Ø Marketing Authorization of Pharmaceutical Products with special Reference to Multisource Batch certificate, when the product is shipped Costa Rica 2005 3

Procedure n 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 4

Product Quality Control Ø At the origin Ø Statement of Licensing Status of Pharmaceutical Product Ø Certificate of Pharmaceutical Product Ø Batch certificate of Pharmaceutical Product Ø In the recipient countries Ø Batch certificate. Ø Quality testing at the Official Lab. of drug quality control Costa Rica 2005 5

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

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) Ø to improve the performance of laboratories Ø to harmonize methodologies Ø to increase communication to promote the quality surveillance of pharmaceutical markets n External Quality Control Program (EQCP) Costa Rica 2005 7

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

Phase I: 23 Official Drug QC Lab. From 21 countries Phase II: 5 steps of performance evaluation with: n Acetyl salicylic acid n Ibuprofen n Acyclovir n Acetaminophen n Streptomycin n Zidovudine Phase III: 5 training workshops in HPLC and Disolution test with Zidovudine, Lamivudine, Quinine, Mefloquine, and Artesunate, in: n Guatemala and Central America countries n Panama and the Caribean countries n Ecuador and the Andean countries n Bolivia and the Amazonic countries n Guyana Costa Rica 2005 9