1. EXTERNAL QUALITY CONTROL PROGRAM OF OFFICIAL DRUG QUALITY CONTROL
LABORATORIES (EQCP)
PROGRAMA DE CONTROL EXTERNO DE CALIDAD
DE LABORATORIOS OFICIALES DE C.C. DE MEDICAMENTOS
(PCEC)
José M. Parisi
PAHO/WHO
March 2-4, 2005

2. EQCP PAHO + USP + Official Drug Q.C. Laboratories
The External Quality Control Program (EQCP) is a PAHO/WHO technical cooperation activity carried out in collaboration with the United States Pharmacopeia (USP) with the participation of the Official Drug Quality Control Laboratories of PAHO Member States.
EQCP
PAHO + USP + Official Drug Q.C. Laboratories
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 Performance evaluation
                         
PHASE III Training of human resources

5. A questionnaire and site visit.
Phase I: Diagnostic study of the Official Drug QC Lab.
A questionnaire and site visit.
To date Phase I includes two 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.
Main results:   
100% have high-performance liquid chromatography (HPLC)
24%   have sufficient staff to implement the Good Lab. Practices (GLP)
  95%   have equipment for dissolution tests
43%   are self-financed
29%   have Operational Manuals as required by ISO norms
24%   have adequate buildings to implement the GLP

6. Phase II: Performance evaluation
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.

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. PROPOSAL (to request)
To the National Drug Reg. Authorities: Support to the Official Drug QC Lab.
to continue to participate in the EQCP
to involve appropriate personnel in the training activities
to establish the network of Official Drug QC Lab. and designate a coordinator
To USP
that it continue to contribute technical and financial support to the EQCP
through an annual plan of operation
to generate standardized protocols of analysis and common reports
To the pharmaceutical industry and to the Universities
To promote the updating and training of analysts in the industry and
university educators in analytical techniques, for supporting future
development of training workshops and improving the quality of the drugs
produced.

10. PROPOSAL TO REQUEST
To the PANDRH: To establish a Working Group on Good Laboratory Practice
(WG/GLP) with the objective of:
To monitor the EQCP
To define the Procedures of the EQCP
To prepare educational materials on GLP and a plan of implementation
That the WG/GLP presents a report on GLP application in the region.