Estudo prévio para validação de limpeza : padronização de procedimentos operacionais padrão e adequação de metodologia analítica para quantificação de resíduos de zidovudina.

Abstract

The cleaning validation is part of the evolution of quality concept and its preparation is essential for compliance with Good Manufacturing Practices, in order to off er qualit y and safety to medicines. Before the validation itself, it is necessary to develop a preliminary study to ensure that the cleaning procedures are logical and , therefore , applicable to pharmaceutical industry routine . This work is a previous study to cleaning validation of equipment used in the production of zidovudine syrup, conducted in coll aboration with the Laboratório Farmacêutico do Estado de Pernambuco - LAFEPE at Liquids Division facilities . To conduct the study, the Standard Operating Proc edures have been updated and modified according the requirements of the Nati onal Health Surveillance Agency, and the selection of zidovudine as worst case contaminant was based on the need of the laboratory to validate the cleaning process for this pharmac eutical active . W ere determined the waste a cceptance limits , and the analytical meth odology for zidovudine determination was adequate and challenged as to its applicability in quantifying the wa ste after the cleaning process. T he analysis of the active res idues showed that the analytical method is ap plicable to validation cleaning and the cleaning process is effective to remove contaminating debris Therefore, the res ults reported by previous study report the necessary basis for the development of validation itself