3.3 Key responsibilities 主要职责

3.3.1 Management responsibilities 管理职责

3.3.1.1 The organization should be supported by the top management of the company

组织应当得到这个公司最高管理的支持

3.3.1.2 The implementation of Good Manufacturing Practices should be the responsibility of top management and should require the participation and commitment of personnel in all departments and at all levels within the company

.GMP 的实施是最高管理阶层的职责并且需要所有部门和每个员工的支持和参与

3.3.1.3 Management should define and communicate the areas in which authorized personnel are allowed to access.

管理职责需要确定相关人员的授权并与之沟通

3.3.2 Responsibilities of personnel 个人职责

ll personnel should:每个人都应;

a)know their position in the organizational structure 知道自己在组织结构中的位置

b)know their defined responsibilities and activities;知道被规定的责任和行为

c)have access to and comply with documents relevant to their particular responsibility scope;有机会获得并符合其特殊的职责范围的文件

d) comply with personal hygiene requirements; 遵守个人卫生要求

e)be encouraged to report irregularities or other non-conformities which may occur at the level of their responsibilities;被鼓励报告非法或不符规定的可能发生在他们职责范围的行为

f)have adequate education training and skills to perform the assigned responsibilities and activities.有足够的教育背景和技能从而胜任规定的职责和活动