3 Personnel 員工
3.1 Princ?iple 原則
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.
任何規范中提到的參與活動的人員應具備生產，控制，儲存合格品的訓練技能
3.2 Organization 組織
3.2.1 Organization c...更多3 Personnel 員工
3.1 Princ?iple 原則
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.
任何規范中提到的參與活動的人員應具備生產，控制，儲存合格品的訓練技能
3.2 Organization 組織
3.2.1 Organization chart 組織結構
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.
應制定組織結構，以確保公司組織和員工職能能被理解，組織機構應適合公司的規模和產品的多樣性
3.2.1.2 Each company should ensure that there are adequate staffing levels in the different scope of activity, according to
the diversity of its production.根據產品多樣性，每個公司應確保在活動的不同范圍都有充足的員工
3.2.1.3 The 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.組織機構應表明
質量保證和質量控制的部門獨立于工廠的其它部門，質量保證和質量控制的職責可以分成兩個也可以合并成一個。
3.2.2 Number of people 員工數量
The company should have an adequate number of properly trained personnel with regards to the defined activities in these
guidelines.
公司應該有一定數量的經過適當有關這個規范培訓的員工
3.3 Key responsibilities 主要職責
3.3.1 Management responsibilities 管理職責
3.3.1.1 The organization should be supported by the top management of the company
.組織應當得到這個公司*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 的實施是*高管理階層的職責并且需要所有部門和每個員工的支持和參與
3.3.1.3 Management should define and communicate the areas in which authorized personnel are
allowed to access.
管理職責需要確定相關人員的授權并與之溝通
3.3.2 Responsibilities of personnel 個人職責
All personnel should:每個人都應;
a) know their position in the organizational structure 知道自己在組織結構中的位置
b) know their defined responsibilities and activities;知道被規定的責任和行為
c) have access to and comply with documents relevant to their particular responsibility scope;有機會獲得并符合其特殊的
職責范圍的文件
d) comply with personal hygiene requirements; 遵守個人衛生要求
e) be encouraged to report irregularities or other non-conformities which may occur at the level of their responsibilities;被
鼓勵報告非法或不符規定的可能發生在他們職責范圍的行為
f) have adequate education training and skills to perform the assigned responsibilities and activities.有足夠的教育背景和
技能從而勝任規定的職責和活動
3.4 Training 培訓
3.4.1 Training and skills 培訓和技能
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.
涉及生產，控制，儲存和裝運的員工要有相關的培訓和經驗，或者其他任何適合其工作的等等
3.4.2 Training and Good Manufacturing Practices 培訓和良好生產規范
3.4.2.1 Appropriate Good Manufacturing Practices training relative to the defined activities of these guidelines should be
provided for all personnel.良好生產規范培訓都要提供給每個人
3.4.2.2 The 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.這個每個人需要培訓，不管什么水平和位置，
所相應的培訓項目要產生并且實施
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.
考慮到每個員工的特長和經驗不同，培訓可以根據每個人的工作和職責來設定
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 external organizations, if necessary.根據需要和現有的可利用資源，培訓課程可
由公司自己編制或由外部專業人士編寫
3.4.2.5 Training should be regarded as a constant and on-going process that is subject to regular
updates.
培訓應該是持續的并能及時更新
3.4.3 Newly recruited personnel 新員工招聘
Besides basic training on the theory and practice of Good Manufacturing Practices, newly recruited personnel should
receive training appropriate to the duties assigned to them.
除了基本的理論和 GMP 培訓，新員工還要他們崗位的培訓
3.4.4 Personnel training evaluations 個人培訓評估
Knowledge accumulated by personnel should be evaluated during and/or after training
.在培訓過程中或者過后，個人知識的積累需進行評估
3.5 Personnel hygiene and health 個人衛生和健康
3.5.1 Personnel hygiene 個人衛生
3.5.1.1 Hygiene programmes should be established and adapted to the needs of the plant. These
requirements should be understood and followed by every person whose activities take them into production, control and
storage areas.
就建立衛生程序并滿足工廠的需要，在生產，控制，儲存區域工作的人員要理解這些要求并且遵守
3.5.1.2 Personnel should be instructed to use hand washing facilities
.每個人要被指導如何使用洗手設備
3.5.1.3 Every person entering production, control and storage areas should wear appropriate clothing and protective
garments to avoid contaminat
