Annals: Series on engineering sciences (Academy of Romanian Scientists) (Jun 2019)
QUALITY ANALYSIS OF PRINTED PHARMACEUTICAL LEAFLET MATERIALS
Abstract
The pharmaceutical packaging with engraved Braille is commonly used today. The paper presents the types of defects that may occur to these packages obtained by offset technology and the performance indicators of the quality specific to the manufacturing organization where the case study was carried out. The production process of pharmaceutical products is governed by the Good Manufacturing Practice quality management system. It’s more restrictive comparative with the ISO 9001:2015 standard. There is targeted the 100% quality and the procedures have a special focus on preventive and corrective actions in order to mitigate the non-conformity risk. In the paper it is analysed using the Ishikawa chart the appearance of the defect "pharmaceutical leaflets printed on one side". Corrective and preventive activities are proposed to eliminate this type of defect.
