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为推行《药品生产质量管理规范(GMP)》,在2000年使80%的药厂达到GMP要求,我省卫生厅今年5月成立了“广东省GMP认证咨询专家组”并于七月七日组织专家召开了第一次审评会,对送审图纸进行了审批.送审图纸虽然未能过“关”,但厂家及设计单位对此心悦诚服,表示要按专家意见重新设计,保证新建药厂符合GMP规定.图纸设计合理与否直接关系着未来厂房及其布局能否达到GMP要求,关系着药品质量能否达到规定标准.为此,根据《药品管理法》第九条及《实施办法》第二十六条,我省卫生厅聘请医药、设计、药
In order to implement the GMP, 80% of the pharmaceutical companies reached the GMP requirement in 2000. The Provincial Department of Health set up the GMP Certification Advisory Group in Guangdong Province in May this year. On July 7 Organizational experts convened the first review meeting to examine and approve the drawings submitted for examination Although the drawings submitted for examination failed to pass the mark, the manufacturers and design institutes were heartfeltly convinced that they were required to redesign according to the opinions of experts and ensure that the new pharmaceutical factory would meet the requirements GMP Provisions Whether the design of the drawings is reasonable or not is directly related to whether the future plant and its layout can meet the requirements of GMP and whether the quality of the medicines can meet the required standards or not.Therefore, according to Article 9 of the Drug Administration Law and Article 9 of the Implementation Measures Twenty-six, our province Health Department hired medicine, design, medicine