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Revista Cubana de Farmacia

versão On-line ISSN 1561-2988

Resumo

JIMENEZ DOMINGUEZ, Leidys Dolores et al. Introduction of Quality and Safety Management System in pig's production with pharmaceutical fates. Rev Cubana Farm [online]. 2010, vol.44, n.2, pp. 160-167. ISSN 1561-2988.

To obtain a biological-origin pharmaceutical raw material (pig useful lung) from young pigs fulfilling the safety and quality requirements to use in drug manufacture (Surfacen®), Quality and Safety Management model was applied in this productive process where work materials used were the Good Practice of Production guidelines, pharmaceutical regulations, requirements of Analysis System of Dangers and Control of Critical Points, as well as the evaluation of productive end efficient indicators. Results obtained corresponding to collected information in diagnosis applied in design stage evidenced in the manual application of Analysis System of Dangers and Control of Critical Points, operation and instructive standardization procedures, and the activity registries. We conclude that the system applied allowed us in staff training, to identify the critical points of process control, to document and record the activities, to increment the controls, as well as to collect data to measure the operations path and give the appropriate responses to client request.

Palavras-chave : Useful lung; pig; raw material; Surfacen.

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