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目的:全面调查北京市医药生产企业临床试验用药品生产质量管理的现状,为今后国家加强和完善临床试验用药品生产质量监管政策提供参考依据。方法:面向北京市医药生产企业进行问卷调查,对回收的有效问卷进行统计分析。结果:临床试验用药品的生产在机构与人员、厂房与设施设备、物料管理情况、生产过程管理、质量控制和质量保证等各个方面与上市药品的生产管理都存在不同。结论:临床试验用药品生产质量的监管政策应当充分考虑到临床试验用药品的生产特点。
Objective: To comprehensively investigate the status quo of quality control of clinical trial drug production in pharmaceutical manufacturing enterprises in Beijing and provide reference for the future countries to strengthen and perfect the regulatory policy of drug production quality for clinical trials. Methods: A questionnaire survey was conducted for pharmaceutical manufacturers in Beijing and statistical analysis of valid questionnaires was conducted. Results: The production of clinical trial drugs differed from that of listed drugs in all aspects such as institutions and personnel, plant and facility equipment, material management, production process management, quality control and quality assurance. Conclusion: The regulatory policy of clinical trial drug production quality should take full account of the production characteristics of clinical trial drugs.