Implementação da verificação continuada de processo em medicamento sólido oral na indústria farmacêutica

Abstract

The national pharmaceutical industry went through an update in the good manufacturing practices as of RDC 30112019, which included the need for the validation approach be performed in three phases: Development (1), Process Validation (2) and continued process verification (3). A scientifically based methodology is fundamental to avoid possible study failures, legislation non-compliance, and excess that could make it unviable. This way, the main of this study was to develop a methodology for suitability and implementation Continual Process verification of in a solid oral medicine in order to evaluate the statistical estate of control of the critical quality attributes. In development of this methodology, were defined the critical quality attributes in phase 2 and established the statistical tools for phase 3. It was applied in an oral solid medicine. As result, the study strategy was defined, with tools capable of show the ability of the process to meet the specification and the results reliability, consolidating a program and standard operational procedure for reproducing the activity. The proposed methodology included the division of phase 3 into phase 3A and 3B, with were applied, with the delivery of the first stage being control limits for monitoring the attributes. In the first phase, 24 batches were monitores and the control limit was define for the dosing and unit dose uniformity attributes. Phase 3B included the monitoring of a further 44 plots and found that both attributes are under control. Thus, it was cocluded that the developed methodology shows secure and viable statistical alternatives to evaluate the state of control of the medicine process, it also can be applied to other drugs developed whitin the life cycle concept.