3 Personnel 员工
3.1 Principle 原则
Persons involved in the implementation of the activities described in these guidelines should have appropriate training to produce, control and store products with a defined quality.任何规范中提到的参与活动的人员应具备生产，控制，储存合格品的训练技能
3.2 Organization 组织
3.2.1 Organization chart 组织结构
3.2.1.1 The organizational structure should be defined in order that the organization and functioning of the staff of the company be understandable. It should be appropriate for the size of the company and the diversity of its products.
应制定组织结构，以确保公司组织和员工职能能被理解，组织机构应适合公司的规模和产品的多样性
3.2.1.2Each company should ensure that there are adequate staffing levels in the different scope of activity, according to the diversity of its production.根据产品多样性，每个公司应确保在活动的不同范围都有充足的员工
3.2.1.3The organization chart should show the independence, from the other units of the plant, of each quality unit, such as quality assurance unit and quality control unit. The quality assurance and quality control responsibilities can be undertaken by a separate quality assurance unit and a quality control unit, or they can be undertaken by a single unit.组织机构应表明质量保证和质量控制的部门独立于工厂的其它部门，质量保证和质量控制的职责可以分成两个也可以合并成一个。
3.2.2 Number of people 员工数量
The company should have an adequate number of properly trained personnel with regards to the defined activities in these guidelines.公司应该有一定数量的经过适当有关这个规范培训的员工
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
3.4 Training 培训
3.4.1 Training and skills 培训和技能
Personnel involved in production, control, storage and shipment should have skills based on relevant training and experience acquired, or any combination thereof, that are appropriate to their responsibilities and activities.涉及生产，控制，储存和装运的员工要有相关的培训和经验，或者其他任何适合其工作的等等
3.4.2 Training and Good Manufacturing Practices 培训和良好生产规范
3.4.2.1Appropriate Good Manufacturing Practices training relative to the defined activities of these guidelines should be provided for all personnel.良好生产规范培训都要提供给每个人
3.4.2.2The training needs of all personnel, regardless of level or seniority in the company, should be identified and a corresponding training programme should be developed and implemented.这个每个人需要培训，不管什么水平和位置，所相应的培训项目要产生并且实施
3.4.2.3 Considering the expertise and experience of the respective personnel, training courses should be tailored to be appropriate to the jobs and responsibilities of individuals.考虑到每个员工的特长和经验不同，培训可以根据每个人的工作和职责来设定
3.4.2.4 According to the needs and in-house resources available, training courses may be designed and executed by the company itself or with the help of expert e