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New revision of the drug production quality management standards (hereinafter re

Time：2017-04-16 11:54:23

       Secondly, highlight the enterprise is the first person responsible for the quality of drugs". According to the previous implementation of GMP in the presence of the main responsibility of the enterprise is not implemented, the initiative is not strong, daily operation in place of, the newly revised GMP emphasized the full participation quality management philosophy, emphasize including investors, enterprises responsible for quality, responsible person, quality authorized person senior management, including the full responsibility for the quality, to the drugs production enterprise quality management responsibilities of the provisions is more comprehensive and in-depth。

      Third, software construction than hardware transformation. The core of the implementation of the newly revised Drug GMP lies in the construction of quality assurance system, the focus is to strengthen the construction of software, rather than the transformation of plant equipment, it is not the capacity to upgrade. Enterprises only truly establish and implement a comprehensive, systematic, scientific quality management system, equipped with adequate resources, including human resources and management system, in order to high quality and efficient operation。