Controle Estatístico de Processo aplicado a uma linha de produção de medicamento tópico de uma indústria farmacêutica

Abstract

The pharmaceutical industry is one of the most competitive and requires constant innovation, dynamism, investments in research and development. The adoption of quality tools in order to ensure efficient production processes that accomplish the parameters defined by companies and legislation, is capable of increasing the productivity of processes, as well as avoiding waste of raw materials, inputs and other industrialization products . Statistical Process Control is one of the quality tools that have a statistical nature, and with the use of charts or graphs of control, allows the visualization of the behavior of the process over time, the control for detection of deviations of parameters representative of the process and the analysis and blocking of possible special causes responsible for the instabilities of the process under study, reducing the quantity of products out of specification and production costs. In this way, this work aims to identify the critical points in the production of drugs in a pharmaceutical industry from the application of control charts. This study is a retrospective analysis of data from 26 batches produced from a topical product line of a pharmaceutical industry during the year 2016, using the data related to the liquid packaging processes considering the parameters of net weight, weight of talcum, tube / valve height, tube / valve diameter and gas container, considering the process parameters of the net gas weight, gross weight and pressure. In the first phase, a descriptive analysis (Action Stat® software) and the normality test for variables (software R, Livre) were performed, applying the Shapiro-Wilk test to evaluate if the sample had a Normal distribution to perform an exploratory verification on viability of application of the control charts, where it was possible to verify that the parameters liquid weight, talc weight, net weight of gas and pressure were normal. However, the parameters of tube / valve height, tube / valve diameter and gross weight were not normal and could not have their control charts considered for the studies. In the second phase, the data that showed normality had their control charts for variables X bar and R, mean and amplitude, applied, in addition to calculations related to the capacity of the process with analysis, interpretation of results and suggestion of improvements, where the following results were observed: 1) the net weight parameter presents a process under control with Cp = 1.05 and Cpk = 0.71 and not able; 2) the weight parameter of the talc presents a process under control with Cp = 0.60 and Cpk = 0.59 and also not able; 3) the parameter net weight of the gas after a second plot of the data was under control and with Cp = 1.17 and Cpk = 1.03 and reasonably capable; 4) the pressure parameter also after a second plot of the data was under control and with Cp = 4.29 and Cpk = 4.16 and able. As an improvement, an Ishikawa Diagram was created for each parameter studied in order to investigate the special causes that may act under the process and a framework that assists in corrective action measures.