Utilização de métodos bootstrap na verificação continuada de processos

Abstract

The product life cycle concept was inserted in the process validation activity at the pharmaceutical industry, comprising three phases. In phase 3, called continuous process verification, there is the determination of control limits for the critical quality attributes and the construction of control charts for monitoring production batches, properly evaluating the state of process control. The definition of the limits of controls and confidence intervals using the bootstrap resampling method, demonstrated by the results obtained to be an alternative to comply with the regulations, when in the portfolio of companies there are products with low production demand, with a restricted size of available samples, an since this method makes it possible to make statistical inferences without the need for assumptions related to sample size or population distribution. In this context, this study presents significant relevance, since, at a low productive volume, traditional methods are not recommended.