Backgroung

This Working Group on Good Laboratory Practice (WG/GLP) was created in June 2005 by recommendation of the Fourth Pan American Conference for Drug Regulatory Harmonization (PARF Network) of PAHO. The formation of this group was based on the excellent work and results obtained up until that time by the external quality control program (PCEC).

The PCEC measures the performance of the official laboratories for control of medicines in the region and sends them blind samples for analysis. The results are evaluated by the United States Pharmacopeia (USP). The medicines controlled to date have been in the PAHO programs on antimalarial drugs, anti-tuberculosis drugs, and HIV/AIDS drugs. The PCEC works under the direction of PAHO/WHO. It has technical assistance and financial support from the USP.

The working group held its first meeting in the city of Panama (1-3 June 2005). At this time, the group was established and defined its mission, objectives, and a 2-year work plan.

Mission 

Strengthen the performance of the official laboratories for control of medicines (LOCM) in the countries of the Region of the Americas through implementation of Good Laboratory Practice, in order to guarantee the quality of the laboratory test results and facilitate mutual recognition of the results.

Objectives

1.  Support implementation of GLP in the LOCM

1.1 Preparation and dissemination of educational material for implementation of the WHO GLP (2002)

1.2 Preparation of a training and continuing education plan

1.3 Technical support for countries that accept the commitment to implement GLP

2. Establishment of a LOCM network

2.1 Formalization of PCEC

2.2  Harmonization of reports on results

2.3 Preparation of a proposal to structure the network

Members of the Working Group on Good Laboratory Practice

Main Members

• MERCOSUR: Sigrid Mathison, Uruguay
• ANDEAN COMMUNITY:Ofelia Villalba, Perú   
• SICA: Nilka Guerrero, Panama
• CARICOM: Lucette Cargill, Jamaica
• USP: Damian Cairatti, United States
• FIFARMA: Thomas Schultz, United States
• Mara Gloria Olate, Chile (Main Coordinator)

Alternate Members

• MERCOSUR: Olga Gruc, Argentina
• ANDEAN COMMUNITY: Cecilia Garnica, Bolivia  
• SICA: Ana Lara Sterling, Cuba
• CARICOM: Mrs. C. Alvarez, Trinidad and Tobago

Secretariat (PAHO/WHO)

• José M. Parisi, Washington, D.C.