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Advisor(s)
Abstract(s)
Desde sempre, que a indústria farmacêutica se caracterizou pelo facto de possuir um controlo
de qualidade exigente. O facto de a saúde do utilizador depender diretamente da qualidade do
produto torna necessário o cumprimento de um conjunto de normas e regulamentos estritos que
permitem alcançar a qualidade exigida para a colocação do produto no mercado. O
cumprimento dos requisitos necessários para a sua comercialização, é um trabalho conjunto
entre todos os departamentos do fabricante. Assim, a qualificação das instalações, dos
equipamentos e dos sistemas é necessária para que um processo esteja validado, garantindo a
qualidade do produto exigida pelos regulamentos.
O trabalho insere-se num contexto de estágio numa empresa de produção de fármacos e em
específico num grupo de trabalho que analisa as necessidades de qualificação da empresa, bem
como todos os aspetos teórico-práticos necessários para a validação de equipamentos de
sistemas e de processos.
Os resultados obtidos serão analisados e validados no decorrer das qualificações efetuadas.
ABSTRACT: The pharmaceutical industry has always been characterized by strict quality control. The fact that the health of the user is directly dependent on the quality of the product makes it necessary to comply with a set of strict rules and regulations that allow the quality required for placing the product on the market to be achieved. The fulfillment of the necessary requirements for its commercialization, is a joint work among all the departments of the manufacturer. Thus, the qualification of facilities, equipment and systems is necessary for a process to be validated, ensuring the product quality required by the regulations. The work is part of an internship context in a drug production company and specifically in a working group that analyzes the qualification needs of the company, as well as all the theoretical and practical aspects necessary for the validation of systems and process equipment. The results will be analyzed and validated during the qualifications made.
ABSTRACT: The pharmaceutical industry has always been characterized by strict quality control. The fact that the health of the user is directly dependent on the quality of the product makes it necessary to comply with a set of strict rules and regulations that allow the quality required for placing the product on the market to be achieved. The fulfillment of the necessary requirements for its commercialization, is a joint work among all the departments of the manufacturer. Thus, the qualification of facilities, equipment and systems is necessary for a process to be validated, ensuring the product quality required by the regulations. The work is part of an internship context in a drug production company and specifically in a working group that analyzes the qualification needs of the company, as well as all the theoretical and practical aspects necessary for the validation of systems and process equipment. The results will be analyzed and validated during the qualifications made.
Description
Keywords
Qualidade Qualificação Validação