EXTERNAL QUALITY CONTROL PROGRAM OF OFFICIAL DRUG QUALITY

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

n 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

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

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

Phase II: Performance evaluation v Objective: to evaluate the performance of the laboratories testing methodology and reporting. v Criteria: as USP evaluation of performance: a) b) c) d) v weighing-in precision equipment reproducibility d) errors standard relative e) data report and interpretation f) limitations of the monograph and 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 Tests of External Control Testing through the shipment of samples and corresponding standards.

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).

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.

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.