
The external quality control program, developed by the Pan American Health Organization/World Health Organization (PAHO/WHO), evaluates the performance of the official laboratories for control of medicines. It has been active since December of 2001 with the assistance of The United States Pharmacopeia (USP).
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.
Key Information
- Background (only in Spanish)
- Programa de control de calidad externo. Informe y propuesta (only in Spanish)
- Directory (only in Spanish)
- External Quality Control Program of Official Drug Quality Control Laboratories- 2005 (ppt)
Phase 1: Diagnostic study of the laboratories
Phase 2: Performance Evaluation
Stage 10:
- General Information
- CoA Pyrazinamide
- MSDS Pyrazinamide
- USP Certificate Pyrazinamide
- Initial letter
- Analysis Report
- Pyrazinamide Tablets
Phase 3: Training of human resources
- Trainning in Peru- Agenda 2012 (only in Spanish)
Technical Documents
- WHO good practices for pharmaceutical microbiology laboratories (2011)
- Document on Self-Evaluation of Good Laboratory Practices (GLP)- 2011 (trilingual)
- pdf Auto Avaliação em Boas Práticas para Laboratório (only in Portuguese)
- pdf Boas Práticas da OMS para laboratórios de controle de qualidade de produtos farmacêuticos (only in Portuguese)
- WHO good practices for pharmaceutical quality control laboratories (2010)
- Study on the current conditions of the Official Medicines Control Laboratories (OMCL) in Latin America and the Caribbean- 2008 (trilingual)