摘要
目的就建立我国GMP认证检查员的法律地位和资质标准提出建议。方法简要回顾了中国GMP认证检查员队伍的形成和发展过程,从法理角度分析了检查员的法定地位,结合实际对检查认证方法进行探讨评估。结果与结论GMP认证是对药品生产行为的法定制度,因此,明确GMP检查员的法律地位与资质标准非常必要。
Objective To offer a proposal about establishing a qualification standard and legal status of the pharmaceutical inspectorate （PI）. Methods By reviewed briefly on the development process of PI in our country, and analyzed PI＇s legal status from a view of law, the certification manner was discussed based on practice. Results and Conclusions GMP certification is a statutory system for pharmaceutical production act, therefore, it is necessary to define the legal status and qualification standards of GMP inspectorates.
出处
《中国药事》
CAS
2009年第8期835-837,共3页
Chinese Pharmaceutical Affairs
关键词
GMP认证
检查员
资质
法律地位
GMP certification
inspectorate
qualification
legal status
