(EQCP) EXTERNAL QUALITY CONTROL PROGRAM OF OFFICIAL CONTROL MEDICINE LABORATORIES Jose M. Parisi AMRO/PAHO December 5, 2007

The External Quality Control Program (EQCP) is an AMRO/PAHO technical cooperation activity carried out in collaboration with the United States Pharmacopeia (USP) with the participation of the Official Control Medicine Laboratories (OMCL) of PAHO Member States. AMRO/PAHO + USP + OMCL to optimize testing capacity and reporting to evaluate the quality of drugs used in priority programs to identify the areas that require technical cooperation to develop the concept of Reference QC Laboratories throughout the region EQCP

Objectives Strengthening the performance in quality control tests Increase communication and exchange of information; Harmonize methodologies to facilitate the acceptance/recognition among countries of the validity of the results obtained.

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

To date Phase I includes three Stages Stage 1 : (2001/02) 18 laboratories from 16 countries from South America, Central America, and Mexico. Stage 2 : (2003/04) 5 laboratories from the Caribbean (Cuba, Dominican Rep, Jamaica, Guyana) and Bolivia. Stage 3 : (2006) 1 laboratory from the Caribbean (Barbados) Main results:  100% have high-performance liquid chromatography (HPLC)  100% have equipment for dissolution tests  24% have sufficient staff to implement the Good Lab. Practices (GLP)  43% are self-financed  29% have Operational Manuals as required by ISO norms  24% have adequate buildings to implement the GLP Phase I: Diagnostic study of the OMCL A questionnaire and site visit.

 Objective: to evaluate the performance of the laboratories testing methodology and reporting.  Criteria: as USP evaluation of performance: a) weighing-in d) errors standard relative b) precision e) data report and interpretation c) equipment f) limitations of the monograph and d) reproducibility familiarity with the USP methods  Results: the laboratories were classified in three groups: Group 1: Laboratories with a level of performance considered Excellent. Group 2: Laboratories with a level of performance considered Good, but do not execute some of the tests, or may have minimal errors to be corrected with appropriate training of their staff. Group 3: Laboratories with a level of performance considered Poor. Phase II: Performance evaluation

Phase II Tests of External Control Testing through the shipment of samples and corresponding standards. StageParticipant Laboratories CountrySample 1 ) Acetil salicylic acid; Ibuprofen 2 ) Acetaminofen 3 ) Streptomycin sterile powder for injection 4 ) Aciclovir 5 ) Zidovudine 6 ) Isoniazide 7 ) Ciprofloxacine

Phase III: Training of human resources. Implementation of workshops and seminars on GLP in Countries that according to the results need more assistance (t o date it includes 4 stages). STAGE (training workshop) DATEPLACEPRODUCTNumber of Trainees 1) HPLC; Dissolution test July 14-17, 2003 GuatemalaARV (Zidovudine)12 2) “ “ “ Nov 17-21, 2003 EcuadorAntimalarial (Quinine)16 3) “ “ “ Oct 19-22, 2004 BoliviaAntimalarial (Artesunate; Mefloquine)10 4) “ “ “ Nov 16-19, 2004 PanamaARV (Lamivudine; Zidovudine)16 5) “ “ “ Dec 06-09, 2005 GuyanaAntimalarial (Chloroquine)10 6) Microbiology Aug 21-25, 2006 PanamaWater and LAL test2 7) HPLC; Dissolution test Feb 12-16, 2007 GuatemalaARV (Saquinavir capsule)10 8) “ “ “ May 14-18, 2007 NicaraguaCiprofloxacine tablets10 9) “ “ “ Jun 18-22, 2007 GuyanaAntimalarial (Coarten)8 10) “ “ “ Aug 20-24, 2007 Dominican RepublicARV (Saquinavir capsule)10 11) “ “ “ Oct 22-26, 2007 JamaicaARV (Lamivudine tablets)8

Educational materials on GLP prepared by AMRO GLP modules for training course Spanish version Portuguese version (in preparation) 36 Report, Annex 3 (English original version) Spanish version Portuguese version Good Practices Self- evaluation Guide English version Spanish version Portuguese version

GLP/ COURSE (36 Report, Annex 3) 1) Dominican Republic 2) Chile 3) Bolivia 4) Honduras 5) Venezuela 6) Guatemala 7) Costa Rica 8) Brazil COUNTRY Number of trainee people

FUTUR ACTIVITIES (2008) To continuous strengthening of OMCL network 8 GLP courses (36 Report, Annex 3) 8 training workshops (HPLC; Dissolution test) 4 seminaries of OMCL pre qualification To follow up of 4 OMCL pre qualification procedure Monitoring of 20 WHO pre qualified drugs EQCP (step # 8)

THANKS FOR YOUR ATTENTION Jose M. Parisi AMRO/PAHO (THS/EV) Pharmaceutical Quality Assurance rd St, NW, Washington, DC Tel: (202) fax: (202)