欧盟和美国检查方法的不同

fruutuun

Differences in EMEA/European Union and FDA Inspection Approach 欧盟和美国检查方法的不同点

FDA	EMEA/European  Union
Inspections检查范围: Ø  Inspect all manufacturing facilities:  API, Drug product, contractors 检查所有的厂房设施：API, 成品，第三方	Inspection检查范围: Ø  Inspect only drug product manufacturing  facilities 只检查生产该产品的生产厂房
Investigators检查员: Ø  Join the FDA after college, often without  having any industry experience (receive a below average salary) 大学毕业加入FDA，常常没有任何行业经验（收入低于平均工资）	Investigators检查员: Ø  Join a EMEA/European regulatory agency  after many years of working in industry; often a Qualified Person (receive a  competitive salary) 有多年行业经验加入EMEA/欧洲药监局，通常是一个合格人员（具有有竞争力的收入）
Audit Approach审计方法: Ø  Focus is on enforcement agency with the  purpose to protect American consumers 执法的目的是保护美国消费者。 Ø  Ensure adherence to the rules 确保遵守法规要求。	Audit Approach审计方法: Ø  Emphasis is on ensuring Quality Systems  are in place; less focused on the rules; more open to alternative approaches  and solutions; concerned with security – how employees can access the  facility and how areas are controlled in order to ensure there is no  possibility of cross-contamination 重点是现场的质量系统，很少关注法规本身，更开放的替代方法和解决方案；关注安全--员工如何进入和控制工厂，以确保没有交叉污染的可能。 Ø  Expect to see well-defined  responsibilities and an organizational chart 希望看到明确的职责和组织结构图。
Conducting the audit:审计实施 Ø  Most time spent reviewing documents and  questioning management 更多的时间花在文件审核和管理问题 Ø  Don’t provide any recommendations during  audit; wait until the end to comment via the FD-483 审计期间不提供任何意见，等到最后汇总成FDA-483评论 Ø  Don’t like the firm to make  recommendations on audit schedule 不喜欢工厂对审计计划提出建议 Ø  Do not accept gratis meals 不接受免费的餐点	Conducting the audit:审计实施 Ø  Spend more time reviewing plant  facilities/operations; watching & interviewing operations, personnel,  clothing, discipline gets more attention 更过时间用于审核工厂/操作；观察&面对面操作。更重视人员、服装的科学性。 Ø  Work to resolve issues with you during  the audit 努力解决审计中你的问题。 Ø  Investigators are open to a recommended  structure for the audit from the firm (suggested agenda/schedule)
Audit Close-out审计关闭: Ø  Written observations issued at close-out  on Form FD-483 Ø  There is no formal assignment of which  observations are the most critical. Typically citations are listed in order  of criticality on FD-483. The first observation listed is usually the most  critical.	Audit Close-out审计关闭: Ø  Verbal observations issues at close-out Ø  Critical, major & minor observations  and points to consider (request for additional information) on written report  issued approximately 2 weeks after inspection Ø  Issue draft report and provide  opportunity for company to clarify and/or correct inaccuracies
Information released to the public公开信息: Ø  Freedom of Information Act (FOIA)  provides the public the opportunity to read FD-483s, Establishment Inspection  Reports, Warning Letters, etc	Information release to public公开信息: Ø  A system like FOIA does not exist in  EMEA/Europe – this information is not made available to the public.

这么近那么远

沙发顶一个，学习了。

sunny1225

道路漫长黑暗

谢谢分享。FDA这个审计期间不提供任何意见以及不接受免费的餐点非常值得借鉴。

一沙一叶

道路漫长黑暗 发表于 2015-1-7 10:40
谢谢分享。FDA这个审计期间不提供任何意见以及不接受免费的餐点非常值得借鉴。

这一条是扯淡  

一沙一叶

这些有争议

叶非

从我接受的检查来看，上述内容扯淡的占多数！估计是哪一年的某个文献！

为胜利而来

原则上如此，实际运作很灵活

小天南星

Investigators检查员:
Ø  Join the FDA after college, often without  having any industry experience (receive a below average salary)
大学毕业加入FDA，常常没有任何行业经验（收入低于平均工资）

FDA检查员的经验还是非常丰富的，检察官分不同级别。

田天向上

好象实际不是那么回事哦