Product Quality Review as an Element of Management Review

Dr. A.A. Spiridonova, Associate Professor, Moscow Technological University, Moscow, Russia, al.spiridonova@gmail.com

Dr. E.G. Khomutova, Professor, Moscow Technological University, Moscow, Russia, khomutova@mail.ru

key words

product quality review, quality management system, GMP, pharmaceutical enterprise

References

The value of the product quality review in the quality management system of pharmaceutical enterprise is proved in this article. Special attention is paid to the analysis of the document contents for carrying out management review in case of development of the integrated quality management system based on GMP and GOST R ISO 9001–2015. The possibility of product quality review development in non-pharmaceutical industrial enterprises is emphasized and the positive sides of the document application are considered. The product quality review content for the manufacturing enterprises is considered in detail and the recommendations concerning the description of each document section are step by step made. The challenges that the organization can face in the development of product quality reviews are analyzed and reasonable ways to overcome it are proved.

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