Validation of processes of production of Active Pharmaceutical Ingredients obtained from derived products of sugar's cane. Practical application

Authors

  • Mirta Elena Cuellar de la Cruz Centro de Bioactivos Químicos (CBQ), Universidad Central de Las Villas (UCLV), carretera a Camajuaní km 5 ½, Santa Clara, Villa Clara, Cuba
  • Heidy Licsie Alonso Rodríguez Centro de Bioactivos Químicos (CBQ), Universidad Central de Las Villas (UCLV), carretera a Camajuaní km 5 ½, Santa Clara, Villa Clara, Cuba
  • Nilo Castañedo Cancio Centro de Bioactivos Químicos (CBQ), Universidad Central de Las Villas (UCLV), carretera a Camajuaní km 5 ½, Santa Clara, Villa Clara, Cuba
  • Margarita de Jesús Fernández Clúa Centro de Bioactivos Químicos (CBQ), Universidad Central de Las Villas (UCLV), carretera a Camajuaní km 5 ½, Santa Clara, Villa Clara, Cuba

Keywords:

Validation of processes, validation of medications, validation of production’s processes

Abstract

The present work is developed with the objective of designing a system of process validation for the Production of Active Pharmaceutical Ingredients (IFA) obtained of derived products of sugar ‘s cane. To achieve this objective analyses type 5W and H are carried out, so giving answers to formulated questions in the application of this quality tool, necessary elements for this system are conformed, as a result, solutions that conform the system’s design are offered and corroborated by the validation of the production’s process of G-1 (2 - bromine -5-(2-bromine-2-nitrovinil)-furano) obtained in the Bioactive Chemical Center.

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Published

2008-01-01

How to Cite

Cuellar de la Cruz, M. E., Alonso Rodríguez, H. L., Castañedo Cancio, N., & Fernández Clúa, M. de J. (2008). Validation of processes of production of Active Pharmaceutical Ingredients obtained from derived products of sugar’s cane. Practical application. Centro Azúcar Journal, 35(1). Retrieved from http://centroazucar.uclv.edu.cu/index.php/centro_azucar/article/view/492

Issue

Vol. 35 No. 1 (2008)

Section

Original Articles

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