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(EQCP) EXTERNAL QUALITY CONTROL PROGRAM

(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

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(EQCP) EXTERNAL QUALITY CONTROL PROGRAM

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

  2. 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. EQCP 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

  3. 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.

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

  5. Phase I: Diagnostic study of the OMCL A questionnaire and site visit. 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

  6. Phase II: Performanceevaluation • 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 withappropriate training of their staff. Group 3: Laboratories with a level of performance considered Poor.

  7. Phase II Tests of External Control Testing through the shipment of samples and corresponding standards.

  8. Phase III: Training of human resources. Implementation of workshops and seminars on GLP in Countries that according to the results need more assistance (to date it includes 4 stages).

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

  10. GLP/ COURSE (36 Report, Annex 3) COUNTRY Number of trainee people

  11. 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)

  12. THANKS FOR YOUR ATTENTION Jose M. Parisi AMRO/PAHO (THS/EV) Pharmaceutical Quality Assurance 523 23rdSt, NW, Washington, DC 20037-2895 Tel: (202) 974 3496 fax: (202) 974 3610 email: parisijo@paho.org

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