1. GESTIÓN DE CALIDAD EN EL DESARROLLO DE PROCESOS Y PRODUCTOS BIOFARMACÉUTICOS.
- Author
-
Fernández, Mercedes Delgado, Melo, Aurora Tamara García, and Valdés, Elizabeth T. Arias
- Subjects
- *
PHARMACEUTICAL biotechnology industry , *BIOTECHNOLOGY industry management , *QUALITY control , *MANUFACTURING processes , *TECHNOLOGY transfer , *BIOPHARMACEUTICS , *ISO 9001 Standard - Abstract
The development of biopharmaceutical products and processes needs the integrated application of regulations, the achievement of quality standards, high qualified people, multidisciplinary teams, the use of high technology and the application of technological transference from the research until the scale-up of productive process. In this sense, the adoption of the quality management is required starting in the R&D stages. This paper focuses in these topics ISO 9001:2000, Good Manufacturing Practices and technology management designed and applied in a Cuban biopharmaceutical enterprise. [ABSTRACT FROM AUTHOR]
- Published
- 2007