ISO 22716: 2007 化妆品良好生产规范 中英文对照（人员、厂房和设施）

官方英文版：

https://www.iso.org/standard/36437.html

官方中文版：

https://std.samr.gov.cn/hb/search/stdHBDetailed?id=8B1827F1C68ABB19E05397BE0A0AB44A

Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices

化妆品良好生产规范

3 Personnel 人员

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.

从事与本标准有关活动的人员应经过适当的培训，以按照规定的质量生产、控制和储存产品。

3.2 Organization 组织

3.2.1 Organization chart 组织结构图

3.2.1.1 The organizational structure should be defined such that the organization and functioning of the staff of the company be understood. It should be appropriate for the size of the company and the diversity of its products.

应规定组织结构，以明确企业的组织和员工职责分工。组织结构应与公司规模和产品相适应。

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.

根据产品多样性，公司应确保人员数量满足不同活动范围的需要。

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. 

质量管理部门，如质量保证部门和质量控制部门，应独立于工厂其他部门。质量保证和质量控制的职责可分别由质量保证部门和质量控制部门承担，也可由单独一个部门承担。

3.2.2 Number of people 人员数量

The company should have an adequate number of properly trained personnel with regards to the defined activities in these guidelines.

企业里从事本标准涉及活动的人员应当充足，并经过适当培训。

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.

组织应得到公司最高管理者支持。

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.

良好生产规范的实施应是最高管理者的职责，同时应要求所有员工参与和保证。

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

组织里的职责和权限应得到规定和沟通。

3.3.2 Responsibilities of personnel 人员职责

All personnel should:

所有员工应：

a) know their position in the organizational structure;

了解自身在组织结构中的位置；

b) know their defined responsibilities and activities;

了解自身的职责和活动；

c) have access to and comply with documents relevant to their particular responsibility scope;

能根据自身职责范围获得相关的文件并遵照执行；

d) comply with personal hygiene requirements;

符合个人卫生要求；

e) be encouraged to report irregularities or other non-conformities which may occur at the level of their responsibilities;

被鼓励报告自身职责范围内出现的异常或不符合情况；

f) have adequate education training and skills to perform the assigned responsibilities and activities.

经过适当的教育培训，具有履行工作职责所需的技能。

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.

基于相关的培训和经验，从事生产、控制、储存和运输的员工应具有与其工作职责相适应的技能。

3.4.2 Training and Good Manufacturing Practices 培训和良好生产规苑

3.4.2.1 Appropriate Good Manufacturing Practices training relative to the defined activities of these guidelines should be provided for all personnel.

应对全体员工进行与本标准涉及活动相关的良好生产规范的适当培训。

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.

应确定全体员工的培训需求，制定相应的培训计划并实施。

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.

培训课程应根据各个员工的专业和经验定制并与其工作和职责相适应。

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. 

根据需要及内部资源的情况，培训课程可由公司内部设计并执行，必要时由外部专家设计并执行。

3.4.2.5 Training should be regarded as a constant and on-going process that is subject to regular updates.

培训应长期持续并定期更新。

3.4.3 Newly recruited personnel 新聘人员

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.

除了良好生产规范理论和实践的基本培训外，新聘人员还应接受与其职责相适应的培训。

3.4.4 Personnel training evaluations 人员培训评估

Knowledge accumulated by personnel should be evaluated during and/or after training.

在培训期间和（或）培训后，应评估员工所积累的知识。

3.5 Personnel hygiene and health 人员卫生和健康

3.5.1 Personnel hygiene 人员卫生

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.

应制定适应工厂需要的卫生制度。进入生产、控制和储存区域的所有人员都应了解并遵守相关要求。

3.5.1.2 Personnel should be instructed to use hand washing facilities.

应指导员工使用洗手设施。

3.5.1.3 Every person entering production, control and storage areas should wear appropriate clothing and protective garments to avoid contamination of cosmetic products.

进入生产、控制和储存区域的人员应穿着适当的服装和防护服，以避免污染化妆品。

3.5.1.4 Eating, drinking, chewing, smoking or the storage of food, drink or smoking materials or personal medication in the production, control and storage areas should be avoided.

应避免在生产、控制或储存区域饮食、吸烟或储存食品、饮料、烟草制品或药品。

3.5.1.5 Any unhygienic practice within the production, control and storage areas or in any other area where the product might be adversely affected should be forbidden.

在生产、控制、储存区域或可能使产品受到不利影响的其他区域应禁止任何不卫生行为。

3.5.2 Personnel health 人员健康

Steps should be taken to ensure, as far as is practicable, that any person affected by an apparent illness or having open lesions on the exposed body surface should be excluded from direct contact with product until the condition is corrected or determined by medical personnel that the quality of cosmetic products will not be compromised.

应采取措施尽量确保患有明显疾病或在暴露的身体表面有开放性损伤的人员不直接接触产品，直至由医务人员治愈或确认其不会影响化妆品质量。

3.6 Visitors and untrained personnel 来访人员与未受训人员

Visitors or untrained personnel should preferably not be taken into production, control and storage areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.

来访人员与未受训人员尽量不进入生产、控制和储存区域。如不可避免，应事先告知其有关情况，尤其是注意个人卫生和穿着规定的防护服，并对其密切监督。

4 Premises 厂房和设施

4.1 Principle 原则

4.1.1 Premises should be located, designed, constructed and utilized so as:

厂房和设施的地点、设计、建造和使用应：

a) to ensure protection of the product;

确保产品得到保护；

b) to permit efficient cleaning, if necessary, sanitizing and maintenance;

允许进行有效的清洁，必要的消毒和维护；

c) to minimize the risk of mix-up of products, raw materials and packaging materials. 

降低产品、原料和包装材料混淆的风险。

4.1.2 Premises design recommendations are described in these guidelines. Design decisions should be based on the type of cosmetic product produced, existing conditions, cleaning and, if necessary, sanitizing measures used.

本标准对厂房设施的设计提出建议。最终的设计应根据所生产的化妆品类型、现有条件、清洁以及必要时采取的消毒措施而确定。

4.2 Types of area 区域类型

Separate or defined areas should be provided for storage, production, quality control, ancillary, washing and toilets.

应分别设置储存、生产、质量控制、辅助和盥洗等区域。

4.3 Space 空间

Sufficient space should be provided to facilitate operations such as receipt, storage and production.

应为接收、储存和生产提供足够的空间以便于操作。

4.4 Flow 流向

Flow of materials, products and personnel through the building or buildings should be defined in order to prevent mix-ups.

应规定物料、产品和人员在建筑物内部和建筑物之间的流向，避免产生交叉污染。

4.5 Floors, walls, ceilings, windows 地面、墙壁、天花板、窗户

4.5.1 Floors, walls, ceilings and windows in production areas should be designed or constructed for ease of cleaning and, if necessary, sanitization and be kept clean and in good repair.

生产区的地面、墙壁、天花板和门窗的设计和构造应易于清洁和必要的消毒，保持清洁并维护完好。

4.5.2 Windows should be of non-opening design where ventilation is adequate. If windows are opened to the outside environment, they should be properly screened.

在通风良好的地方，窗户应为封闭式设计。如窗户对外部环境打开，应有适当的掩蔽。

4.5.3 New construction of production areas should incorporate considerations for proper cleaning and maintenance. Design of new construction should include smooth surfaces if appropriate and these surfaces should allow for resistance to corrosive cleaning and sanitizing agents.

生产区新建的地面、墙壁、天花板和门窗应考虑适当的清洁和维护，其表面应光滑耐腐蚀。

4.6 Washing and toilet facilities 盥洗设施

Adequate, clean, washing and toilet facilities should be provided for personnel. The washing and toilet facilities should be differentiated from, but accessible to, production areas. Adequate facilities for showering and changing clothes should be provided when appropriate.

应为人员提供足够、洁净的盥洗设施。盥洗设施应与生产区分离，但易于到达生产区。适当时应提供足够的淋浴和更衣设施。

4.7 Lighting 照明

4.7.1 Adequate lighting, that is sufficient for operations, should be installed in all areas.

所有区域应安装足够的照明设施，照度应满足操作的要求。

4.7.2 Lighting should be installed in a manner to ensure containment of any debris from potential breakage.Alternatively, measures should be taken to protect the product.

照明设施的安装应防止其破碎时碎片可能造成的污染，或采取相应措施保护产品。

4.8 Ventilation 通风

Ventilation should be sufficient for the intended production operations. Alternatively, specific measures should be taken to protect the product.

生产时应保证良好的通风，或采取特定措施保护产品。

4.9 Pipework, drains and ducts 管道工程管、排水管与输送管

4.9.1 Pipework, drains and ducts should be installed in such a manner so that drip or condensation does not contaminate materials, products, surfaces and equipment.

管道工程管、排水管与输送管的安装应防止水滴或冷凝水对物料、产品、表面和设备造成污染。

4.9.2 Drains should be kept clean and should not allow back flow. 

排水管应保持清洁，防止回流。

4.9.3 Design considerations should be given to the following:

设计应考虑：

a) exposed overhead roof beams, pipes and ducts should be avoided;

避免屋顶横梁、管道和输送管暴露在外；

b) exposed pipes should not touch walls, but be suspended from or supported by brackets, sufficiently separated to allow thorough cleaning;

暴露在外的管道不应接触墙壁，应采用托架悬挂或支撑，与四周有足够的间隔以便于彻底清洁；

c) alternatively, specific measures should be taken to protect the product.

或采取特定措施保护产品。

4.10 Cleaning and sanitization 清洁和消毒

4.10.1 Premises used for activities described in these guidelines should be maintained in a clean condition.

用于本标准所涉及活动的厂房和设施应保持清洁。

4.10.2 Cleaning and, if necessary, sanitization should be carried out to achieve the objective of protecting each product.

应进行清洁及必要的消毒，以达到保护产品的目的。

4.10.3 Cleaning and, if necessary, sanitizing agents to be used should be specified and effective.

应规定所使用的清洁剂及必要的消毒剂并保证其有效性。

4.10.4 There should be cleaning and, if necessary, sanitization programmes corresponding to specific needs of each area.

应根据各个区域的需要制定清洁及必要的消毒程序。

4.11 Maintenance 维护

Premises used in activities described in these guidelines should be maintained in a good state of repair.

用于本标准所涉及活动的厂房和设施应加以维护，保持良好状态。

4.12 Consumables 消耗品

Consumables used for premises should not affect the quality of the product.

用于厂房和设施的消耗品不得影响产品质量。

4.13 Pest control 虫害控制

4.13.1 Premises should be designed, constructed and maintained so as to restrict access to insects, birds, rodents, pests and other vermin.

厂房和设施的设计、建造和维护应能有效防止昆虫、鸟类、啮齿动物和其他害虫的进入。

4.13.2 There should be a pest control programme appropriate for the premises.

应制定适当的厂房虫害控制制度。

4.13.3 Measures should be taken to control the exterior of the premises to prevent attracting or harbouring pests. 

应采取措施防止厂房外部虫害的聚集和孳生。