新版GMP实施过程中厂房改造的探讨

摘要

Several aspects, including whether or not the plant should be reconstructed or retransformed during the implementation of new GMP, guarantee of organization system of the implementation of the project, plant design and process layout, the objective and scientiifc risk assessment to the project design, quality control in the progress of project implementation, full estimation of project resources so as to better manage the progress of the project and so on, were described in order to ensure that the company can complete the construction of the plant or the acceptance of its transformation in accordance with the requirements of the project in a limited period of time and to guarantee that the plant can meet the requirements of the new GMP and its intended use and furthermore to provide a reference for the sustained and stable production in the future.%本文对新版GMP的实施过程中是否新建或改造厂房、项目实施的组织体系保证、厂房设计及工艺布局、项目设计环节客观科学的风险评估、项目实施过程中的质量控制、充分预估项目的资源以做好项目的进度管理等方面进行了阐述，以便在有限的时间内既按照工程要求完成厂房的新建或改造验收，又确保厂房符合预定用途及新版GMP的要求，为保证日后持续稳定地生产提供借鉴。