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首页> 外文期刊>Independent Journal of Management & Production >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”
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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”

机译：生物制药行业的全面质量管理：“用于研究和开发人类血浆衍生产品的产品和工艺的质量功能部署（QFD）的规划和开发”

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摘要

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.
机译：在工业领域，研发部门的工作与执行的过程以及将要上市的产品有关，包括从新产品的设计和开发到重新设计或开发过程的一切。生产。因此，只要响应迅速而有效，响应时间便是公司结构中的关键点。此外，开发和设计的质量不仅限于产品的优势。药品研发的质量功能部署（QFD）似乎是一种重要工具，使我们能够根据客户需求以及他们对产品质量要求的期望来面对产品或过程的设计或修改。在这项工作中，我们根据QFD规则处理血浆衍生产品的开发。 QFD的应用满足了建议的目标。 QFD为产品增加了简单性和可靠性，并为产品开发和最终产品本身增加了安全性和极具竞争力的成本。 QFD补充了良好生产规范（GMP），并且即使在未寻求质量体系认证的情况下，它也被证明在制药行业具有很高的适用性。

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