Letter from America
SÃO PAULO, BRAZIL, July 23, 1997
Dear Colleague,
MERCOSUL is the Treaty for Free Trade between Argentina, Paraguay, Uruguay and Brazil, aiming at regional integration, technical harmony, scientific and academic interchange. In the health products area, this Treaty assumes a vital importance because it leads to a uniformity of methods and processes that not only avoids discussion, but ensures the maintenance of high standards of quality assurance in the development, manufacture and control of pharmaceutical products.
The Treaty determined that joint inspection of manufacturing operations would be the basis for Microbiological Control of Health Products. In order to ensure that all inspectors have the same level of expertise, and that all analysis and actions would be the same for the four countries, a Three-Phase course was planned.
Phase I was developed by each country individually, taking into account its own requirements, while bearing in mind that the technical rules had to be in line with those of the Treaty. During this first phase, 200 inspectors from the four countries attended courses on manufacturing and control practices for pharmaceutical products.
Phase II, with all countries present, was held in, and co-ordinated by, Argentina. This phase qualified 29 professionals, bringing them to a level of expertise common to all the Treaty countries, with capability to demand the fulfilment of requirements related to quality, safety and efficiency of products subjected to microbiological control.
In Brazil, at this very moment, we are holding Phase III of the course, involving 26 inspectors (2 from Paraguay, 3 from Uruguay, 10 from Argentina and 11 Brazilians). The event is supported by the Brazilian Ministry of Health, the Brazilian Ministry of Science and Technology, and includes 12 experts from the Treaty countries to act as co-ordinators (4) and moderators (8), in addition to the eight guest speakers. The specific aim of Phase III is to deepen the inspectors’ knowledge of Validation of production processes, Sterilization by moist and dry heat, Air systems, Water systems, Aseptic filling and Statistical plans for sampling. The guest speakers in Phase III are either Brazilian independent consultants or representatives of Brazilian manufacturing operations, each one an expert in his (her) field, training and sharing their experience with the Treaty Inspectors. A number of the consultants are members of the SBCC (Brazilian Society of Contamination Control), and use the SBCC Recommended Practice documents as a basis for their presentations.
We believe that this is the first of many steps to ensure the maintenance of high standards of quality assurance in the manufacturing of pharmaceutical products in the MERCOSUL.
Sincerely
Eliane Salgado Ferreira Bennett
