Development and optimization of preservative systems using Quality by Design (QbD) concepts

• Grant number: 16/17451-3
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: July 01, 2017
• End date: June 30, 2018
• Field of knowledge: Health Sciences - Pharmacy - Medicines Analysis and Control
• Principal Investigator: Felipe Rebello Lourenço
• Grantee: Juliana Thaynara Fidelis Pinto
• Host Institution: Faculdade de Ciências Farmacêuticas (FCF). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

In the pharmaceutical industry there is a great concern to ensure the quality and effectiveness of their products. With this, strategies have been adopted to provide security during the manufacturing process, as well as, in the final product. In order to achieve excellence in their actions, the industry introduced two specific sectors: quality control and quality assurance incorporating good manufacturing practices Good manufacturing practices (GMP) are intended to ensure the sanitary quality and compliance in the manufacture of pharmaceuticals and/or cosmetics with regulators, satisfying the criteria of international standards and quality system. Compliance with the GMP is intended to mitigate risks or critical points during the production process, which can often not be planned or altered inappropriately. New quality tools are being deployed by the pharmaceutical industry/cosmetics in order to reduce errors during the production process, aiming at the optimization, cost reduction and the guarantee of a product within the standards of quality. Among the quality tools, we can cite the Quality by Design (QbD) whose goal is to evaluate different responses to certain variables for the design of a process that has the ability to produce robust and secure form lots which comply, without rejection throughout the life cycle of the process and/or product. Process Analytical Technology (PAT) is based on a solid analysis system in order to obtain qualitative and quantitative information on the manufacturing process, be they chemical, physical (rheological analyses, surfaces, etc.) and/or biological, as well as concepts such as instrumentation, sampling, sample transport, flow engineering and chemometrics, ensuring product quality in the final phase of the process. Through this, this project aims to evaluate the components of pharmaceutical formulation development of preservatives for topical formulations and systems correlate concepts of quality management system as the Quality by Design (QbD) and Process Analytical Technology (PAT), for use as tools in the industrial area ensuring the effectiveness, safety and quality of pharmaceuticals. (AU)