Good Manufacturing Practices: first priority for drug regulators in the Region

Within the framework of the Pan American Network for Drug Regulatory Harmonization, the implementation of Good Manufacturing Practices (GMP) was identified as the first priority for the Region and educational activities were identified as the most relevant strategy for technical cooperation.

In this context, in April 2001, a 10-day workshop on GMP took place in Jamaica for the CARICOM countries. The workshop was attended by 18 participants from regulatory authorities, ministries of health, universities and other institutions. The training programme covered all the modules on the Basic Prin-ciples of GMP and included a manufacturing site visit to a small local factory.

The educational modules were translated into Spanish. From August 2001 to September 2002, 18 national seminars on GMP were held in 18 out of the 19 Latin American countries of the American Region. Six professors from pharmacy schools in Colombia, Costa Rica, Mexico and Venezuela and two independent experts were selected as trainers for the seminars.

More than 500 professionals from governments, academia, the pharmaceutical industry and related organizations were trained. This multi-institutional participation was widely recognized by both the public and private sectors as appropriate technical cooperation in this area.

Evaluations from each seminar indicate a high level of satisfaction among participants. The main recommendations include follow-up national seminars in specific specialized areas such as: validation of analytical methods, validation of processes, sterile compounds, documentation, bioequivalence and other subjects according to the particular need of each country.