(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: parisijo@paho.org