版药品gmp认证检查评定标准解读qa.doc

2008年版药品GMP认证检查评定标准解读 机构与人员 *0301企业应建立药品生产和质量管理机构，明确各级机构和人员的职责。 1、组织机构图应包括企业各部门的设置、隶属关系、职责范围及各部门之间的关系、部门负责人。其中生产和质量管理部门应分别独立设置，负责人不得兼任。质量管理部门受企业负责人直接领导。 2、岗位职责包括各级领导的岗位职责、各部门及负责人职责（特别是质量管理部门应有独立的权限，能对生产等部门执行《药品生产质量管理规范》进行监督和制约，职责应包括《药品生产质量管理规范》规定中的所有内容）、各岗位的职责（应体现GMP的所有规定，做到权、责明确，无交叉，无空白）。 3、部门之间的共同职责，应在部门职责中分别体现，但描述上应有所区别。如：供应商的审计是生产、质量和物料管理等部门的共同职责。 0302企业应配备一定数量的与药品生产相适应的具有相应的专业知识、生产经验及工作能力，应能正确履行其职责的管理人员和技术人员。 1、企业管理人员一览表、企业技术人员一览表、企业质量管理人员一览表。基本内容包括：姓名、职务、职称学历、毕业院校、所学专业、从药年限、所在岗位等。 2、有关人员的学历、职称、执业药师、各类外出培训证书等相关材料的复印件。生产及质量管理相关中层干部的任命文件。 3、以上人员均应为全职人员，不能兼职或挂名 Safety Supervision Bureau of the partys mass line educational practice reform program to promote the implementation of the rectification, establish a new system to work, in accordance with the requirements of the county Party committee, County Safety Supervision Bureau leadership check out the four winds there are problems, make the following implementation of the rectification program. First, the guiding ideology and basic principles of (a) guide thought: the partys eighteen, the eighteen session of the second, the Third Plenary Session of the spirit as a guide, conscientiously implement the spirit of general secretary Xi Jinpings important speech series, in strict accordance with the look in the mirror, dress up, wash bath, cure treatment, the general requirements, focus on maintaining the partys advanced nature and purity, closely linked to the people and pragmatic clean the main And look in the mirror, dress up, wash bath, cure treatment, the general requirements of focus to solve the four winds issue, the priority among priorities rectification as firmly put the four winds, the system construction is the fundamental strategy of the comprehensive wipe out the root cause, in order to promote the implementation of the rectification and the establishment of the work to ensure that educational practice from start to finish, good to do good, credibility, benefit the