Desenvolvimento de um plano de amostragem na indústria farmacêutica

Abstract

This work presents a Sample Plan of a case to guarantee and improve the quality of patients in the pharmaceutical industry, with the help of Quality Assurance tools. The Sampling Plan was developed to meet the requirements of regulatory bodies such as the FDA and ANVISA. The objective was achieved through theoretical guidelines and research in the literature, explaining important concepts and definitions for understanding the theme. Processes were analyzed and defined that help the development of the Sampling Plan, this organized was presented as a tool to be a way to guarantee the quality of a certain productive process. In the pharmaceutical industrial segment, the risks involved are known, since they are directly linked to the health of the consumer, so some errors at the end of the production of a medicine can be catastrophic. Thus, with the research carried out, exchanges of information, analyzes of real cases and risk analyses, the Sampling Plan can be developed in the safest possible way.