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(guī)范中提到的參與活動(dòng)的人員應(yīng)具備生產(chǎn)，控制，儲(chǔ)存合格品的訓(xùn)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(guī)范中提到的參與活動(dòng)的人員應(yīng)具備生產(chǎn)，控制，儲(chǔ)存合格品的訓(xùn)練技能
3.2 Organization 組織
3.2.1 Organization chart 組織結(jié)構(gòu)
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(yīng)制定組織結(jié)構(gòu)，以確保公司組織和員工職能能被理解，組織機(jī)構(gòu)應(yīng)適合公司的規(guī)模和產(chǎn)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(jù)產(chǎn)品多樣性，每個(gè)公司應(yīng)確保在活動(dòng)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(jī)構(gòu)應(yīng)表明
質(zhì)量保證和質(zhì)量控制的部門獨(dú)立于工廠的其它部門，質(zhì)量保證和質(zhì)量控制的職責(zé)可以分成兩個(gè)也可以合并成一個(gè)。
3.2.2 Number of people 員工數(shù)量
The company should have an adequate number of properly trained personnel with regards to the defined activities in these
guidelines.
公司應(yīng)該有一定數(shù)量的經(jīng)過適當(dāng)有關(guān)這個(gè)規(guī)范培訓(xùn)的員工
3.3 Key responsibilities 主要職責(zé)
3.3.1 Management responsibilities 管理職責(zé)
3.3.1.1 The organization should be supported by the top management of the company
.組織應(yīng)當(dāng)?shù)玫竭@個(gè)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(shí)施是*高管理階層的職責(zé)并且需要所有部門和每個(gè)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(zé)需要確定相關(guān)人員的授權(quán)并與之溝通
3.3.2 Responsibilities of personnel 個(gè)人職責(zé)
All personnel should:每個(gè)人都應(yīng);
a) know their position in the organizational structure 知道自己在組織結(jié)構(gòu)中的位置
b) know their defined responsibilities and activities;知道被規(guī)定的責(zé)任和行為
c) have access to and comply with documents relevant to their particular responsibility scope;有機(jī)會(huì)獲得并符合其特殊的
職責(zé)范圍的文件
d) comply with personal hygiene requirements; 遵守個(gè)人衛(wèi)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(lì)報(bào)告非法或不符規(guī)定的可能發(fā)生在他們職責(zé)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(guī)定的職責(zé)和活動(dòng)
3.4 Training 培訓(xùn)
3.4.1 Training and skills 培訓(xùn)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(chǎn)，控制，儲(chǔ)存和裝運(yùn)的員工要有相關(guān)的培訓(xùn)和經(jīng)驗(yàn)，或者其他任何適合其工作的等等
3.4.2 Training and Good Manufacturing Practices 培訓(xùn)和良好生產(chǎn)規(guī)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(chǎn)規(guī)范培訓(xùn)都要提供給每個(gè)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(gè)每個(gè)人需要培訓(xùn)，不管什么水平和位置，
所相應(yīng)的培訓(xùn)項(xiàng)目要產(chǎn)生并且實(shí)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(gè)員工的特長和經(jīng)驗(yàn)不同，培訓(xùn)可以根據(jù)每個(gè)人的工作和職責(zé)來設(shè)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(jù)需要和現(xiàn)有的可利用資源，培訓(xùn)課程可
由公司自己編制或由外部專業(yè)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(xùn)應(yīng)該是持續(xù)的并能及時(shí)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(xùn)，新員工還要他們崗位的培訓(xùn)
3.4.4 Personnel training evaluations 個(gè)人培訓(xùn)評估
Knowledge accumulated by personnel should be evaluated during and/or after training
.在培訓(xùn)過程中或者過后，個(gè)人知識(shí)的積累需進(jìn)行評估
3.5 Personnel hygiene and health 個(gè)人衛(wèi)生和健康
3.5.1 Personnel hygiene 個(gè)人衛(wèi)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(wèi)生程序并滿足工廠的需要，在生產(chǎn)，控制，儲(chǔ)存區(qū)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(gè)人要被指導(dǎo)如何使用洗手設(shè)備
3.5.1.3 Every person entering production, control and storage areas should wear appropriate clothing and protective
garments to avoid contaminat
