| In the background of economic globalization, the industries have been changing greatly.And it will influence the whole world more and more profound and extensive. Although the pharmaceutical packaging industry is smaller, but it services a high-tech, high-margin, and high-quality requirement industry-pharmaceutical, which needs it to be more sophisticated and rigorous, and to keep moving with the time.After studying the whole process of the pharmaceutical packaging development, the author thinks that the whole industry is in the junction of transformation and upgrading. However, in the past,some Medical Packaging Company came to some quality problems in the research and development of new products which caused the investment is not so smooth, or even failure.In this paper, the author analyses the problems existing in the HM company and gets the result:lack of management on the quality of R&D, such as lack of education on quality, the imperfect on the quality management system, not clear on the related quality requirement, and lack of studying on the quality on the process of R&D.Based on previous research result, the basic principle of standardized, ISO9001, quality by design theory, quality risk management theory, quality function deployment, idea, the author proposes some suggestions for the HM company medicinal packaging R&D quality. Which including:the studying of quality system on different level of R&D process, prevent the quality risk of R & D, establish and improve the quality management system.Based on the features of medicinal packaging products, the author proposes the a term of "quality-related persons". which means the quality of packaging materials and drugs have a certain relationship with some institutions or personnel, such as raw materials suppliers, customers, packaging equipment suppliers, relevant government departments, doctors and patients, and so on. After considering all the requirement of the quality, the R&D of pharmaceutical packaging can be successful. |
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