Controle estatístico de processo aplicado a uma linha de medicamento tópico de uma indústria farmacêutica

Abstract

The pharmaceutical industry is one of the most competitive and requires constant innovation, investments in research and development, and the adoption of efficient competitive strategies. Statistical Process Control (SPC) is a statistical tool capable of providing support to fulfill quality and decision-making requirements. The use of control charts allows the visualization of the behavior of the process over time, the control for detection of deviations of representative parameters and the analysis and blocking of possible special causes. This study aims to identify, through the SPC by applying the control cards X bar and R (mean and amplitude), if the variables of interest present significant variation and critical points in a stage of the production of a topical drug. This is a retrospective analysis of the liquid packaging process data from 26 topical product batches produced during the last quarter of 2016, considering the in-process control data of the following parameters: net weight, talc weight, height of the tube / valve and diameter of the tube / valve, for the creation of control graphs, besides the establishment of the indices of process capacity to analyze the studied process.