Establecimiento del límite aceptable para el residuo de limpieza en los equipos de producción de la industria farmacéutica

at present, the demands of the governing bodies of good manufacturing practice aimed at assuring the quality and consistency of pharmaceuticals are increasing. one of the basic aspects that the authorities make emphasis on is the cleaning validation program, particularly the validation of manufacturing equipment cleaning methods. there is no clear-cut guide to setting cleaning residues limit but very general guidelines for a great variety of drugs and manufacturing situations. to this end, the paper gathered and analyzed different criteria for estimation and selection of the acceptable residue limit. some solutions for certain situations that may occur in practice were suggested and the importance of a right limit setting was underlined. it is expected that this paper be useful for the detection of situations where each limit approach may be convenient.