Periodicity.: July - September 2018
e-ISSN......: 2236-269X
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Total Quality Management in the biopharmaceutical industry: "Planning and development of Quality Function Deployment (QFD) for the research and development of products and processes of human plasma derived products”

Sergio Alejandro Oviedo Albarracin


In the industrial sector, the work of the research and development departments is related both to the processes performed and to the products to be marketed, and it includes everything from the design and development of a new product to the redesign or development of the process of production. Therefore, response time represents a key point in the structure of the company, provided that the response is fast and effective. Besides, the quality of the development and design is not limited to the benefits of the product. Quality Function Deployment (QFD) for Pharmaceutical Products Research and Development appears as an important tool that allows us to face the design or modification of a product or process according to customers needs, and to their expectations about the product quality requirements. In this work we deal with the development of a plasma derived product, on the basis of QFD rules. The application of QFD fulfilled the proposed objectives. QFD added simplicity and reliability to the production as well security and highly competitive costs to both, the product development and the final product itself. QFD was supplemented with Good Manufacturing Practices (GMP), and it also proved to be highly applicable in the pharmaceutical industry even in the case that certification for a quality system is not pursued.


QFD; Biopharmaceuticals; Quality Management; Human Plasma Products

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