FDA的结论是,“警告信中的重要发现表明,质量部门无法充分行使其权力和/或责任”。基于违反GMP的性质,FDA强烈建议聘请顾问。
以下缺陷引述显示了实验室中GMP合规性似乎存在严重问题:“你们的分析人员向我们的检查人员提供了来自互联网搜索的未经验证的分析方法,该方法似乎不适用于你们的药品,也不适合任何药品。 The FDA asked the company to provide, beside others, the following information: FDA要求该公司提供以下信息: An assessment ...
FDA的结论是,“警告信中的重要发现表明,质量部门无法充分行使其权力和/或责任”。基于违反GMP的性质,FDA强烈建议聘请顾问。
资质上传入口需要上传「生产企业GMP证书」、「美国化妆品FDA备案证明」和「外包装/标签实拍图」,即代表该产品需要做OTC资质认证(如图所示) 4如何上传FDA资质 登录商家后台,进入「商品」-「商品管理」页面 - 选择相应的产品 点击【编辑】商品 -「美国资质」- 上传「美国化妆品FDA备案证明」 - 上传「外包装/标签实拍...
In some countries, a GMP certificate is awarded by an official agency after a thorough inspection. In the US, no certificate is issued—full responsibility for compliance remains with the company. When required by law, governments ensure compliance through review of new product sub...
In addition to GMP failures, unapproved drug claims were another common observation made among violative hand sanitizer products. For example, the Spartan Chemical Company’s hand sanitizer product claims to be “effective in shortening the duration of infection and preventing infection or disease from...
Management System CertificationGMP, BSCI, ISO 13485ISO 9001, ISO 9000, GMP, FSCISO 9001, ISO 9000, GMP, FSCISO 9001, ISO 9000, GMP, FSCISO 9001, ISO 9000, GMP, FSC Trade Capacity Export MarketsNorth America, South America, Eastern Europe, Western EuropeNorth A...