Qualidade por design na operação unitária de liofilização de um produto biológico

Abstract

The pharmaceutical industry has being implementing regulatory practices to assure that consumers obtain products with quality, safety and efficacy. The use of Quality by Design (QbD) for products on development has increased though the years to avoid problems related to the lack of planning of limits of acceptance of quality parameters. As a holistic vision, the QbD has been suggested by Regulatory Agencies to standardize globally the documentation necessary for the registration of new products. Although the concepts of QbD gain importance for products under development it is still not a widespread practice to existing systems and products already on the market. Therefore, this work aims to propose a case study with a measles, mumps and rubella vaccine using QbD concepts on the lyophilization unit operation production step to provide robustness and increase efficiency, leading to a lyophilization cycle time reduction. To achieve this, instead of designing the process from product development, as recommended by the international quality guides, a historical database of production process, its results, and its non-conformities, risk analysis tools, and statistical analysis were applied in the vaccine production as a case study. With this, it was possible to propose a methodology for mapping critical parameters and the formation of a design space in the lyophilization unit operation. With the generation of better product and process knowledge from the methodology it is expected to predict risks through a scientific knowledge base, assuring regulatory agencies that the producer has a broad knowledge and control of the activities of this unitary operation and that can assure products with the required quality.