(EQCP) EXTERNAL QUALITY CONTROL PROGRAM OF OFFICIAL CONTROL MEDICINE LABORATORIES Jose M. Parisi...
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Transcript of (EQCP) EXTERNAL QUALITY CONTROL PROGRAM OF OFFICIAL CONTROL MEDICINE LABORATORIES Jose M. Parisi...
(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.
Stage Participant Laboratories
Country Sample
1 ) 2001 17 20 Acetil salicylic acid; Ibuprofen
2 ) 2001 18 19 Acetaminofen
3 ) 2002 17 19 Streptomycin sterile powder for injection
4 ) 2003 21 19 Aciclovir
5 ) 2004 21 19 Zidovudine
6 ) 2005 21 19 Isoniazide
7 ) 2007 23 21 Ciprofloxacine
Phase III: Training of human resources.
Implementation of workshops and seminars on GLP in Countries thataccording to the results need more assistance (to date it includes 4 stages).
STAGE
(training workshop)
DATE PLACE PRODUCT Number of Trainees
1) HPLC; Dissolution test July 14-17, 2003 Guatemala ARV (Zidovudine) 12
2) “ “ “ Nov 17-21, 2003 Ecuador Antimalarial (Quinine) 16
3) “ “ “ Oct 19-22, 2004 Bolivia Antimalarial (Artesunate; Mefloquine) 10
4) “ “ “ Nov 16-19, 2004 Panama ARV (Lamivudine; Zidovudine) 16
5) “ “ “ Dec 06-09, 2005 Guyana Antimalarial (Chloroquine) 10
6) Microbiology Aug 21-25, 2006 Panama Water and LAL test 2
7) HPLC; Dissolution test Feb 12-16, 2007 Guatemala ARV (Saquinavir capsule) 10
8) “ “ “ May 14-18, 2007 Nicaragua Ciprofloxacine tablets 10
9) “ “ “ Jun 18-22, 2007 Guyana Antimalarial (Coarten) 8
10) “ “ “ Aug 20-24, 2007 Dominican Republic ARV (Saquinavir capsule) 10
11) “ “ “ Oct 22-26, 2007 Jamaica ARV (Lamivudine tablets) 8
Educational materials on GLP prepared by AMRO
GLP modules for training courseSpanish versionPortuguese version (in preparation)
36 Report, Annex 3 (English original version)Spanish versionPortuguese version
Good Practices Self- evaluation GuideEnglish versionSpanish 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
35
66
25
39
56
33
44
30
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 523 23rdSt, NW, Washington, DC 20037-2895 Tel: (202) 974 3496 fax: (202) 974 3610 email: [email protected]