摘要:目的:研究FDA的医药产品cGMP相关的警告信。方法:采用统计分析的方法,对FDA医药产品cGMP相关的警告信进行分析讨论,推测FDA对医药产品质量管理体系监管重点和意图。结果与结论:FDA警告信的内容非常有价值,对把握世界医药产品质量管理的趋势和改进质量管理水平有很大帮助。
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