Pharmaceutical industrial equipment qualification in Brazil: a strategic test proposal for vaccine secondary material packaging lines

Abstract

This research has as main objective prepare a qualification plan for vaccines secondary material packaging lines, in order to guide its practice and to define the tests required for the pharmaceutical industry in Brazil. This study sought to ensure product quality and health through better testing planning needed for proper installation, operation and performance of the equipment, as the few existing national regulations are generic regarding this type of approach. For this, a literature review was conducted using the most comprehensive research bases of scientific articles to describe the state of the art on the subject. The survey questionnaire was applied to the qualification and validation specialists. The use of a statistical tooling helped in the process of identification of the tests which cannot be missed within a quality planning. It is expected that the result of this study, through the development of a qualification plan, will add safety, reproducibility and effectiveness to the quality of the product and facilitate regulatory compliance with regulatory agencies. In addition, this plan will aim to contribute to other equipment and systems aimed at guiding specialists in qualification activities and the advancement of literature research.