GMP中“文件”是指一切涉及药品生产、管理的书面标准和实施过程中的记录结果。“文件”在药品制造的GMP全过程最终都是以“文件”的形式反映的。无论世界卫生组织的GMP ,还是欧共体的GMP或我国的GMP ,均把“文件”单独列出作为一章 ,由此可见文件的重要程度。欧共体GMP“文件 GMP “document” refers to all involved in the production and management of pharmaceutical written standards and the implementation of the results of the record. The “document” in the pharmaceutical manufacturing GMP eventually the whole process is reflected in the form of “documents.” Regardless of the GMP of the World Health Organization, or the GMP of the EC or the GMP of our country, the “documents” are separately listed as a chapter, thus the importance of the documents can be seen. EC GMP "document