INVESTIGADORES
RAMIREZ RIGO Maria Veronica
congresos y reuniones científicas
Título:
Teaching good documentation practices using problem-based learning. Implementation of a practical class in the chair of Industrial Pharmacy at Universidad Nacional del Sur.
Autor/es:
CESCHAN NE; ARNABOLDI C; RAMÍREZ RIGO MV
Lugar:
Córdoba
Reunión:
Congreso; 3° Reunión Internacional de Ciencias Farmacéuticas (RICiFa 2014); 2014
Institución organizadora:
Universidad Nacional de Córdoba
Resumen:
Documentation is an essential requirement of Good Manufacturing Practices (GMP). It defines procedures and specifications of all products and methods of manufacturing and control that ensure the quality of medicines. It is considered that about 20-30% of the deviations detected during inspections to the pharmaceutical industry are related to documentation. For this reason it was identified as an important topic to be addressed through a practical class during the implementation of Industrial Pharmacy (a new optative chair in the career of Pharmacy at UNS). The aim of activity designed was to enhance student?s skills in the identification, preparation and correction of documents under international standards using problems as a tool for the acquisition and integration of concepts. Through fictitious problematic situations, documents required for establishing quality policy of an industry and ensuring product quality were identified. Functionality, purpose and requirements of each identified document were determined. Besides, strategies of document redaction were considered. The practical activity was divided in two sections and took around 90 min. First, the type of documents required in pharmaceutical industry, as well as their structure and contents were introduced by the tutor using a brief presentation. Thus, it was possible to work in the resolution of problematic situations following the documentation requirements demanded by GMP during the second part of the activity. Students were able to develop a production order for capsules and appropriately rewrite a standard operating procedure for cleaning lab-countertops in production areas. The sharing at the end of the class allowed the group enrichment of knowledge acquired. The final test demonstrated the objective achievement. The implementation of the practical class about documentation was didactic and simple as well as effective to improve the abilities of students of Pharmacy at UNS to face their future challenges.