Outsourcing e regulação sanitária :como a desverticalização afeta os requisitos regulatórios e o sistema da qualidade farmacêutico

Abstract

The pharmaceutical industry has experienced a de-verticalization movement, especially involving outsourcing which, despite its potential advantages, entails a tendency to quality risk increasing. In this scenario, companies need to address new demands to the quality system in order to mitigate that risk, assure regulatory compliance, and achieve desired performance. This process of de-verticalization also affects regulatory authorities that need to adjust their acting and requirements, consequently impacting the organizations. The objective of this work is to advance the pharmaceutical quality system knowledge in the context of outsourcing starting from the analysis of the Brazilian health authority perspective and discussing its impacts in the industry, mainly in the scope of quality, but also in the operational strategy.