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ISO22716 审核检查表CHECK LIST

发表时间:2019-05-16 08:50


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Scope of audit:

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Note: The number in the checklist is referenced to the clause number of the standard.


3. Personnel 人事

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3.1 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.对于参与指南中提及的活动的执行者,应当有明确的的关于生产,控制及储存货物质量的培训。







3.2 Organization 机构

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 product.公司员工应了解公司明确的组织结构图以及其体制及运作,该组织结构图应适用于各类型公司及各项产品。







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.根据工厂产品的多样性,工厂需确保在各项生产活动中都有足够的员工人数。







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.组织结构图应在工厂的另一单位中独立展示每个品质单位,如质量保证部门及质量控制部门。质量保证及质量控制部门可以由分别独立的品质保证部及品质控制部门负责,也可有同一个部门管控。







3.2.2 Number of people 员工人数

The company should have an adequate number of properly trained personnel with regards to the defined activities in these guidelines.在参与该指南定义的活动中,工厂应有足够的且参与过适当培训的员工人数。







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.该机构应得到最高管理层的支持。







3.3.1.2    The implementation of the 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由最高管理层负责,且需要公司各个部门及各个级别的员工的参与及承诺。







3.3.1.3    Management should define and communicate the areas in which authorized personnel are allowed to access.管理层应针对允许授权人员访问方面给出定义并传达。







3.3.2 Responsibilities of personnel 个人职责

All personnel should: 所有人员应当:

a) know their position in the organizational structure;知道自身在组织架构中的职位;

b) know their defined responsibilities and activities;知道自身的职责及工作;

c) have access to and comply with documents relevant to their particular responsibility scope;对于相关文件特定的自身职责范围应了解并遵守;

d) comply with personal hygiene requirements;遵循个人健康要求;

e) be encouraged to report irregularities or other non-conformities which may occur at the level of their responsibilities; 对于举报可能发生在其职责范围内的违规现象及不遵守项给予鼓励。

f) have adequate education training and skills to perform the assigned responsibilities and activities.有足够的培训教育及技能来执行分配下来的工作及职责;







3.4 Training培训

3.4.1 Training and skills 培训及技能

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.参与生产,控制,仓储及装货的工作人员应获得基于其工作岗位的培训和经验,或者适合他们职责及工作的任何组合。







3.4.2 Training and Good Manufacturing Practices 培训及良好生产规范

3.4.2.1    Appropriate Good Manufacturing Practices training relative to the defined activities of these guidelines should be provided for all personnel.应为所有员工提供关于良好生产规范的培训。







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.应为公司的所有阶层的员工定制并实施相应的培训。







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.考虑到个人的专业知识和经验,定制的培训课程应适合个人的工作及职责。







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 organization, if necessary.根据需求及内部资源的许可性,培训课程可由公司自身设计并执行,如有必要,也可请求外部专家的协助。







3.4.2.5    Training should be regarded as a constant and on-going process that is subject to regular updates.培训应当视为一个常态的,持续不断的过程,应定期更新。







3.4.3 Newly recruited personnel 新雇佣人员

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.除了关于良好生产规范的基本理论和实践的培训外,新雇佣人员还需接受适合他们职责范围的培训。







3.4.4 Personnel training evaluations 人员培训评估

Knowledge accumulated by personnel should be evaluated during and/or after training.应在培训过程中或培训完成后对个人的知识累计做出评估。







3.5 Personnel hygiene and health 个人卫生与健康

3.5.1 Personnel hygiene 个人卫生

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.应建立卫生程序且该程序应适用于工厂的需求。要求所有人员了解且遵循该要求并将其投入生产,控制及仓储区域中。







3.5.1.2    Personnel should be instructed to use hand washing facilities.应要求员工使用工厂内洗手器。







3.5.1.3    Every person entering production, control and storage areas should wear appropriate clothing and protective garments to avoid contamination of cosmetic product.所有进入生产,控制及仓储区域的员工应穿着适当的工作服及防护服以避免化妆品产品污染。







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.在生产,控制及仓储区域应避免吃,喝,咀嚼,吸烟或者储存食物,饮料,吸烟物品或个人药物。







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,控制及仓储或其他可能影响产品质量的区域都应禁止任何不卫生的行为。







3.5.2 Personnel health 个人健康

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.应采取相关措施(只要是可行的)以确保任何有明显疾病或身体外露部分有损伤的人员都不应直接接触产品,直到个人情况好转或者由医务人员证实其不会影响到化妆产品后方可接触产品。







3.6 Visitors and untrained personnel 来访者及未经训练人员

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 personnel hygiene and the prescribed protective clothing. They should be closely supervised.来访者及未经培训的人员最好不要进入生产,控制及仓储区域;如上述情况不可避免,那么该人员应事先了解须注意事项,特别是个人卫生及穿戴规定的工作服方面,另外,该人员应受到密切的监督。





















4 Premises 经营地址

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4.1 Principle 原则

4.1.1 Premises should be located, designed, constructed and utilized so as: 经营地址的位置,设计,建造及使用遵循如下几点:

a
to ensure protection of the product; 确保可以保护产品。

b
to permit efficient cleaning, if necessary, sanitizing and maintenance;能够进行高效的清洁,如有必要还能够进行消毒和维护;

c
to minimize the risk of mix-up of products, raw materials and packing materials.能够将产品,原材料和包装材料的混合风险降至最低。







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.在指南中有描述关于经营地址的设计建议。设计方式应取决于工厂生产的化妆品产品,现有条件,清洁及有必要的话需考虑消毒和维护措施。







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.分开或已界定好的区域都应有仓储,生产,质量控制,辅助,洗涤及厕所。







4.3 Space空间

Sufficient space should be provided to facilitate operations such as receipt, storage and production.应以供足够的空间以便操作,如接收,储存及生产。







4.4 Flow流程

Flow of materials, products and personnel through the building or buildings should be defined in order to prevent mix-ups.材料,产品及个人在建筑物内或建筑物之间的流动都应被明确以防止混乱发生。







4.5 Floors, walls, ceilings, windows 地板,墙面,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.在生产区域的地板,墙壁,天花板及窗户应设计或建造为易于清洗的,如有必要,还应进行卫生处理并保持清洁及维修。







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.在通风足够的环境中,窗户应设计为非开合。如果窗户向外部环境打开,则应适当的屏蔽。







4.5.3    New construction of production areas should incorporate considerations for proper cleaning and maintenance. Design of new construction should include smooth surface if appropriate and these surfaces should allow for resistance to corrosive cleaning and sanitizing agents.在生产区域中的新建筑物应该考虑合适的清洁及维护,新的建筑物如适用,应使用光滑的墙面,且该墙面能够抵抗耐腐蚀性的清洁及消毒。







4.6 Washing and toilet facilities 清洗及厕所设施

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. 应为个人提供足够的,清洁的清洗及厕所设施,清洗及厕所设置应当是有区别的且易接近生产区域的;如适用,还可提供足够冲洗及换衣场所。







4.7 Lighting 光照

4.7.1    Adequate lighting, that is sufficient for operations, should be install in all areas.应有足够的照明安装在各个区域用以操作。







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.灯具应按规则安装,以确保防止任何潜在的破损;或者采取相应的保护产品措施。







4.8 Ventilation 通风设备

Ventilation should be sufficient for the intended production operations. Alternatively, specific measures should be taken to protect the product.通风设施应满足预定的生产操作;或者采取相应的产品保护措施。







4.9 Pipework, drains and ducts 管道,排水管道及通风管道

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,排水及通风管道应按照要求安装,水滴及凝结物不会污染到材料,产品,表面及设备。







4.9.2    Drains should be kept clean and should not aloe back flow.排水管道应保持清洁,且不能够回流。







4.9.3    Design considerations should be given to the following:应考虑如下设计要素:

a
exposed overhead roof beams, pipes and ducts should be avoided;应避免暴露的高架屋顶梁,管道及通风管道;

b
exposed pipes should not touch walls, but be suspended from or supported by brackets, sufficiently separated to allow thorough cleaning;裸露在外的管道不应靠墙,而应悬吊或者由支架支撑,且有足够的空间用以清洁;

c
alternatively, specific measures should be taken to protect the product.另外还需采取具体措施用以保护产品。







4.10 Cleaning and sanitization 清洁及卫生

4.10.1    Premises used for activities described in these guidelines should be maintained in a clean condition.指南中指出用于活动的经营场所应保持卫生环境。







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(如有必要还需进行消毒)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.应定期进行有效的清洁(如有必要可使用卫生消毒剂)。







4.10.4    There should be cleaning and, if necessary, sanitization programmes corresponding to specific needs of each area.应有针对各个区域的相应清洁(如有必要还需进行消毒)计划。







4.11 Maintenance 维护

Premises used in activities described in these guidelines should be maintained in a good state of repair.指南指出用以经营的场所应保持一个良好的修护状态、







4.12 Consumables消耗品

Consumables used for premises should not affect the quality of the product.经营场所使用的耗材产品不可影响产品质量。







4.13 Pest control 害虫防治

4.13.1    Premises should be designed, constructed and maintained so as to restrict access to insects, birds, rodents, pests and other vermin.应设计,建造及维护经营场所以防止昆虫,鸟类,老鼠害虫及其他有害物的进入。







4.13.2    There should be a pest control programme appropriate for the premises.经营场所应有适当的害虫控制程序。







4.13.3    Measures should be taken to control the exterior of the premises to prevent attracting or harbouring pests.应采取措施控制经营场所以防止吸引或窝藏害虫。










5 Equipment 设备

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5.1 Principle原则

Equipment should be suitable for the intended purpose and capable of being cleaned and, if necessary, sanitized and maintained. This clause applies to all equipment within the scope of these guidelines. If automated systems are introduced into activities described in these guidelines, they should take into account the application of the given relevant principles.设备应适合预期的目的及能够被清洗,如需要还可被消毒及维修。这个要求适用于所有在指南中提及的设备。如果在指南中描述的工作项中有自动化系统引入,则应考虑已给出的应用程序相关原则。







5.2 Equipment design 设备设计

5.2.1 production equipment should be designed to prevent contamination of the product.生产设备的设计应能够防止产品污染。







5.2.2 Bulk product containers should be protected from air contaminants, such as dust and moisture.散货产品容器应防止空气污染,如灰尘及水汽。







5.2.3 Transfer hoses and accessories that are not in use should be cleaned and, if necessary sanitized, kept dry and protected from dust, splash or other contamination.不使用的输送管及配件应清洗(如必要可消毒),并保持干燥存放以保护其不受灰尘,水滴或其他污染。







5.2.4 The material used in the construction of equipment should be compatible with products and the cleaning and sanitizing agents.用于设备构成的材料应为能够与产品兼容且清洁并消毒的。





















5.3.1    The design and the installation of equipment should ease its drainage in order to facilitate cleaning and sanitization.设备的设计和安装放宽其排水系统以便于清洁及消毒。







5.3.2    Equipment should be placed so that movement of materials, mobile equipment and personnel do not pose a risk to quality.设备应为安放好的,这样,材料,通讯设备及人员的移动就不会造成质量风险。







5.3.3    Reasonable access under, inside and around equipment should be provider for maintenance and cleaning.应合理检查设备的内外以便于设备的维护及清洁。







5.3.4    Major equipment should be readily identifiable.大型设备应易于识别







5.4 Calibration 校准

5.4.1    Laboratory and production measuring instruments that are important for the quality of the product, should be calibrated regularly.实验室及生产质量仪器对于生产质量非常重要,应进行定期校准。







5.4.2    If results of calibration are out-of-acceptance criteria, measuring instruments should be appropriately identified and removed from service.如果校准的结果超出可接受范围标准,衡量工具应进行适当的鉴定并停止使用。







5.4.3    An out-of-calibration condition should be investigated to determine if there is any impact to the quality of the product and appropriate steps taken based on this investigation.应调查超出标准情况以确定是够有任何影响产品质量的情况并基于此调查采取适当的措施。







5.5 Cleaning and sanitization 清洁及卫生处理

5.5.1    All equipment should be subject to an appropriate cleaning and, if necessary, sanitization programme. 所有的设备都应经过适当的清洁(如需要还可消毒)程序。







5.5.2    Cleaning and sanitizing agents should be specified and effective.清洁及消毒剂应是指定且有效的。







5.5.3    Where equipment is assigned to continuous production or production of successive bathes of the same product, equipment should be cleaned and, if necessary, sanitized at appropriate intervals.当设备指定为连续生产使用或继续为生产同一产品服务的,该设备应该给予清洁,如有必要,还可进行适当的间隔性消毒。







5.6 Maintenance维护

5.6.1    Equipment should be regularly maintained.设备应定期维护







5.6.2    Maintenance operations should not affect the quality of the product.维护操作不应影响产品生产质量。







5.6.3    Defective equipment should be identified accordingly, excluded from use and isolated if possible.有缺陷的设备应及时发现,如可能,应将其独立防止不再使用。







5.7 Consumables消耗品

Consumables used for equipment should not affect the quality of the product.设备使用的耗材不应影响产品的质量







5.8 Authorization授权

Equipment or automated systems used in production and control should be accessed and used by authorized personnel.在生产及控制过程中使用的设备或自动化程序应经过授权方可进入及使用。







5.9 Back-up systems备份系统

Adequate alternative arrangements should be available for systems which need to be operated in the event of a failure or breakdown.为系统配置足够的备份以便应对系统发生故障或系统崩溃。










6 Raw materials and packaging materials原材料及包装材料

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6.1 Principle原则

Raw materials and packaging materials that are purchased should meet defined acceptance criteria relevant to the quality of finished products.已购买的原材料及包装材料应符合关于成品质量可接受标准。







6.2 Purchasing 采购

Purchasing of raw materials and packaging materials should be based on:采购原材料及包装材料应遵循以下:

a
evaluation and selection of the supplier;供应商的评估及选择;

b
establishment of technical clauses such as type of selection to be conducted, acceptance criteria, actions in the case of defect or modifications, transport conditions;建立技术准则例如:进行类型的选择,接受标准,在缺陷及修正案例中的行动,运输条件;

c
setting of relations and exchanges between the company and supplier such as questionnaire, assistance and audits.制作公司及供应商之间关系及交流平台,如文件,协助及审查。







6.3 Receipt收据

6.3.1    The purchase order, the delivery note and the delivered materials should match.订单,交付记录及交付的材料应该是匹配的。







6.3.2    The integrity of the raw materials and packaging materials shipping containers should be checked visually. If necessary, additional checks of transport data should be performed.应检查原材料及包装材料集装箱的完整性;如必要,可额外检查其运输数据。







6.4 Identification and status 识别及状态

6.4.1    Containers of raw materials and packaging materials should be labelled in order to identify the material and the batch information.原材料及包装材料的装箱应该贴有标签用以识别材料及批次信息







6.4.2    Raw materials and packaging materials showing defects that might affect product quality should be held pending a decision.有缺陷且可能影响产品质量的原材料及包装材料应抽起另做决策。







6.4.3    Raw materials and packaging materials should be identified in an appropriate way according to their status such as accepted, rejected or quarantined. Other systems can replace this physical system of identification, if they ensure the same level of assurance.应使用适当的方法确认原材料及包装材料的状态,如可接受,被拒绝或隔离;在确保其他系统也具有同等保证时,也可使用其他系统代替此确认方法。







6.4.4    Identification of raw materials and packaging materials should contain the following information:确认原材料及包装材料须包含以下几点:

a
name of the product marked on the delivery note;记录送货单上标明的产品名称;

b
name of the product as given by the company, if different from the name given by the supplier and/or its code number; 如供应商提供的产品名称与公司提供的产品名称或编码不同,使用公司提供的产品名称。

c
date or number of receipt, if appropriate;如适用,记录收据的日期及数量。

d
supplier’s name;记录供应商名称

e
batch reference given by the supplier and the one given at receipt, if different.如批次号不相同,记录供应商提供的批次参考及收据上的批次号。







6.5 Release发放

6.5.1    Physical or alternative systems should be set up to ensure that only released raw materials and packaging materials are used.应建立检查或可代替的系统用以确保只发放原材料及包装材料。







6.5.2    The release of materials should be carried out by the authorized personnel responsible for quality.材料的发放应由负责质量的人员负责。







6.5.3    Raw materials and packaging materials can be accepted on the basis of the supplier certificate of analysis only if there are established technical requirements, experience and knowledge of the supplier, supplier audit and agreed supplier’s test methods.只要供应商能够提供其已建立了关于经验及知识技术要求,供应商审核及同意供应商测试方法的分析证书,其原材料及包装材料即可被接受。







6.6 Storage仓储

6.6.1    Storage condition should be appropriate for each raw materials and packaging materials.仓储条件应适用于各种原材料及包装材料。







6.6.2    Raw materials and packaging materials should be stored and handled in a manner appropriate to their characteristics.原材料及包装材料应根据其特性来存放及操作。







6.6.3    Specific storage conditions should be respected and monitored, where appropriate.如适用,要对特殊储存条件材料引起重视并对其进行监控。







6.6.4    Containers of raw materials and packaging materials should be closed and should be stored off the floor.储存原材料及包装材料的容器应是密封包装并其离地摆放。







6.6.5     When raw materials and packaging materials are repacked, they should carry the same labeling as at origin.当原材料及包装材料再包装时,应贴上与原标签相同的标签。







6.6.6    When raw materials and packaging materials are quarantined or rejected, they should be stored in their respective physical locations or by using any other system providing the same level of assurance.对于被隔离或被拒收的原材料及包装材料,应将其分别储存在特定的位置或者使用其他系统确保与上述相同的保障。







6.6.7    Measures should be set up to ensure stock turnover. Except in special circumstances, stock rotation should ensure that the oldest released stock is used first.应建议相应措施以确保库存周转率,除特殊情况外,存货周转应确保先使用最旧的材料。







6.6.8    Periodic inventory should be performed to ensure stock reliability. Any significant discrepancy should be investigated and corrective action taken.应执行定期盘存以确保存货的可靠性,任何重大的差异都应立即展开调查及纠正行动。







6.7 Re-evaluation 再评估

A system should be set up to re-evaluate materials as appropriate to determining their suitability for use, after a defined period of storage. The system should be set up so as to prevent the use of materials which require re-evaluation.应建立一个适当的再评估材料系统用以确认经过一段存储其的材料是否仍然能够正常使用。建立此系统用以防止需要进行再评估的材料直接使用。







6.8 Quality of water used in production生产用水质量

6.8.1    The water treatment system should supply a defined quality of water.水处理系统应给用水质量提供一个标准。







6.8.2    Water quality should be verified by either testing or monitoring of process parameters.用水的质量应经测试或检测处理参数核实。







6.8.3    The water treatment system should permit sanitization.用水处理系统应允许进行卫生处理。







6.8.4    Water treatment equipment should be set up so as to avoid stagnation and risks of contamination.应建立用水处理装置用以避免堵塞及污染的风险。







6.8.5    Materials used in water treatment equipment should be selected to ensure that water quality is not affected.应正确选择水处理装置使用的材料以确保用水质量不受影响。












7. Production生产

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7.1 Principle原则

At each stage of manufacturing operations and packaging operations, measures should be taken to produce a finished product that meets the defined characteristics.在生产操作及包装操作的各个阶段都应采取措施以确保生产产品符合其特征。







7.2 Manufacturing operations生产操作

7.2.1 Availability of relevant documents相关文件的可用性

7.2.1.1    Relevant documentation should be available at each stage of manufacturing operations.在生产操作的各个阶段的文件应齐全且可用。







7.2.1.2    manufacturing operations should be carried out according to manufacturing documwntation,

including: 生产操作应该根据生产文件进行,包括以下:

a
suitable equipment;使用适合的器材

b
formula for the product;使用适合的产品配方

c
list of all raw materials identified according to relevant documents indicating batch numbers and quantities;根据相关文件标明的批次号及数量列出所有原材料;

d
detailed manufacturing operations for each stage, such as addition of raw materials, temperatures,

speeds, mixing times, sampling, cleaning and, if necessary, sanitizing of equipment, and bulk product transfer.将生产操作的各个阶段细节化,如增加的原材料情况,温度,速度,混合时间,样品情况,清洁情况,如必要可添加设备卫生情况,以及散货产品转化,







7.2.2 Start-up checks 生产前检查

Before starting any manufacturing operations, it should be ensured that:在开始任何生产操作前,都应确保一下几点:

a
all documentation relevant to the manufacturing operations is available;所有相关生产操作的文件都可用;

b
all raw materials are available and released;所有原材料都已取得并可用;

c
suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized;适当的设备是可用的,在工作状态中的,清洁的且消过毒的(如适用);

d
clearance of the area has been performed to avoid mixing with materials from previous operations.已和之前的生产区域隔开以避免材料与上一次生产材料混合。







7.2.3 Assignment of a batch number批次号分配

A batch number should be assigned to each batch of manufactured bulk product. This number does not need to be identical with the batch number that appears on the label of the finished product, but, if not, it should be easy to relate to that number.对每一批生产的产品都应分配一个批次号,这个数字不需和成品上的标签号一致,但这个数字可以和标签号有关。







7.2.4 Identification of in-process operations 识别进程中的操作

7.2.4.1    In accordance with the formula, all raw materials should be measured or weighed, into clean and suitable containers labelled with appropriate identification or directly into the equipment used for manufacturing.根据标准,所有原材料都应经过测量及称重后放入适合且清洁的容器并贴上适当的标签或直接放入设备内进行生产。







7.2.4.2    At all times, it should be possible to identify major equipment, containers of raw materials and containers of bulk products.不论何时,都应确认大型设备,安放原材料容器及散货储存箱。







7.2.4.3    Identification of containers of bulk products should indicate:安置散货的箱子应具备如下:

a
name or identifying code;名字或识别号

b
batch number;批次号

c
storage conditions when such information is critical to assure the quality of the product.当储存条件是确保产品质量的重要标准时,还需标明存储条件







7.2.5 In-process control 进程中控制

7.2.5.1    In-process controls and their acceptance criteria should be defined.应给过程控制及验收标准进行定义。







7.2.5.2    In-process controls should be performed according to a defined programme.过程控制应该根据制定好的程序执行。







7.2.5.3    Any result outside the acceptance criteria should be reported and appropriately investigated.任何不被验收标准所接受的情况都应向上报告并作出适当的调查。







7.2.6 Bulk product storage散货储存

7.2.6.1     Bulk product should be stored in suitable containers, in defined areas, and under appropriate conditions.散货应储存在适当的容器内,指定的区域内以及有适当的储存条件。







7.2.6.2    The maximum bulk product storage duration should be defined.应对产品的最大储存时间应作出定义。







7.2.6.3    When this duration is reached, the bulk product should be re-evaluated before use.当存货达到了最大储存时间,这些散货需要经过再评估程序后方可使用。







7.2.7 Re-stocking raw materials重回库存的原材料

If raw materials remain unused after weighing and are intended and deemed acceptable to return to stock, their containers should be closed and properly identified.如果原材料在称重后仍未使用且被认定为可重新放入库存的,安置该原材料的容器应密封且作出正确的标识。







7.3 Packaging operations包装操作

7.3.1 Availability of relevant documents相关文件的可用性

7.3.1.1    Relevant documentation should be available at each stage of packaging operations.包装操作各个阶段的相关文件应齐全且可用。







7.3.1.2    Packaging operations should be carried out according to packaging documentation including:包装操作应根据包装文件进行,如下:

a
suitable equipment:使用正确的设备

b
list of packaging materials defined for the intended finished product;将打算用作成品包装的材料列出来;

c
detailed packaging operations such as filling, closing, labelling, and coding.包装操作的细节,如:填充,封口,贴标机编码。







7.3.2 Start-up checks 工作前检查

Before starting any packaging operation, it should be ensured that:在开始任何包装操作前,都应确保如下:

a
the area has been cleared of materials to avoid mixing with materials from previous operations;工作区域已经清扫以避免与之前操作的材料混合;

b
all documentation relevant to the packaging operations, is available;所有相关包装操作文件是可用的;

c
all packaging materials are available;左右包装材料是可用的;

d
suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized;适当的设备是可用的,在工作状态的,清洁的且消过毒的(如适用);

e
any coding to permit identification of the product is defined.制定能够识别产品的编码;







7.3.3 Assignment of batch number批次号分配

7.3.3.1    A batch number should be assigned to each unit of finished product.每个成品都应分配一个批次号;







7.3.3.2    This number does not need to be identical with the batch number that appears on the label of the bulk product, but, if not, it should be easy to relate to that number.该批次号不需要和散装产品的批次号一致,但该号码可以和其有联系。







7.3.4 Packaging line identification包装线识别

At all times, it should be possible to identify the packaging line with its name or identifying code, the name or identifying code of the finished product and the batch number.不论何时,都应能够根据生产线的名字或识别号,成品及批号的名字及识别号 识别包装线。







7.3.5 Checks of on-line control equipment在线控制设备检查

If used, on-line control equipment should be regularly checked according to a defined programme.如有需要,在线控制设备应根据制定的程序做定期检查,







7.3.6 In-process control进程控制

7.3.6.1    In-process controls and their acceptance criteria should be defined.应对进程控制及接受标准进行定义。







7.3.6.2    In-process controls should be performed according to a defined programme.进程控制应根据制定的程序执行。







7.3.6.3    Any result that is outside the acceptance criteria should be reported and appropriately investigated.任何在验收标准范围外的时间都应向上汇报并作出适当的调查。







7.3.7 Re-stocking of packaging materials再回仓的包装材料

If packaging materials remain unused after packaging operations and are intended and deemed acceptable to return to stock, their containers should be closed and properly identified.如果包装材料在包装操作完成后仍未使用,且被认定为可放置会仓库的,安置该材料的容器应密封且作上适当的标志。







7.3.8 Identification and handling of work-in-process半成品的识别和处理

Filling and labelling is usually a continuous process. Where this is not the case, special measures including segregation and identification should be applied so that no mix-ups or mislabelling can occur.填充及贴标通常是持续的程序;事实上,会应用特别的标准(如分离及标识),防止混合和错乱贴标是事件发生。










8. Finished product产成品

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8.1 Principle原则

Finished product should meet the defined acceptance criteria.产成品应符合验收标准定义

Storage, shipment and returns should be managed in a manner so as to maintain the quality of finished products.对于储存,运送及返厂都应有相应的程序以维持产成品的质量。







8.2 Release发放

8.2.1   Prior to being placed on the market, all finished product should be controlled in accordance with established test methods and should comply with acceptance criteria.在产成品上市前,所有的产成品都应根据建立好的测试方式及应该遵守的验收标准进行控制。







8.2.2   Product release should be carried out by the authorized personnel responsible for quality.产品的发放应由负责质量的授权人员进行。







8.3 Storage储存

8.3.1    Finished products should be stored in defined areas under appropriate conditions for an appropriate length of time, If necessary, finished products should be monitored while stored.产成品应储存在有特定条件及时间段的特定区域;如有需要,应产成品的存放进行监控。







8.3.2    Storage areas should permit organized storage.仓储区域应有组织的存放。







8.3.3    When finished products are released, quarantined or rejected, they should be stored in their respective physical locations or by using any other system providing the same level of assurance.当产成品发放,隔离或拒收时,其应分开存放于单独的位置或者使用其他能够有同等保障的系统管理。







8.3.4    Identification of finished product containers should indicate:识别成品容器应包含以下:

a) name or identifying code; 名称及识别号

b) batch number;批次号

c) storage conditions when such information is critical to assure the quality of the product;如储存条件是保障产品质量的准则,则须标明产品质量;

d) quantity.数量







8.3.5 Measures should be set up to ensure stock turnover.

Except in special circumstances, stock rotation should ensure that the oldest released stock is used first.应建立相应标准以确保库存周转率,除特殊情况外,存货周转应确保优先适用最老的存货。







8.3.6 Periodic inventory checks should be performed to:应定期检查库存:

a
ensure inventory accuracy;确保库存的准确性;

b
ensure that acceptance criteria are met.确保满足验收标准;

Any significant discrepancy should be investigated.任何重大差异都应展开调查。







8.4 Shipment装货

Measures should be taken to ensure the shipment of the defined finished product.应采取措施以确保产成品的装载。

Precautions should be taken to maintain the finished product quality , when appropriate.如适用,还需采取预防措施以维持产成品的质量。







8.5 Returns返厂

8.5.1    Returns should be identified in an appropriate way and stored in defined area.应制定一个适当的返厂方式及货物的储存地点。







8.5.2    Return need to be evaluated against established criteria to determine their disposition.对于返厂货物应制定标准用以确定其处理方式。







8.5.3    Release should be given before placing returns on the market again.在货物重返市场前应先发行。







8.5.4    Measures should be established to distinguish any reprocessed return. Measures should be taken to avoid the inadvertent redistribution of unreleased finished product.










9 Quality control laboratory质量控制实验室

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9.1 Principle 原则

9.1.1    Principles described for personnel, premises, equipment, subcontracting, and documentation should apply to the quality control laboratory. 描述人员、场所、设备、分包和文档的原则都应适用于质量控制实验室。







9.1.2    The quality control laboratory is responsible for ensuring that the necessary and relevant controls, within its activity, are carried out for sampling and testing so that materials are released for use and products are released for shipment, only if their quality fulfils the   required acceptance criteria.质量控制实验室应对确保必要及相关的控制负责,在其工作时进行采样及测试,只有在其质量满足要求验收标准的情况下,该这材料可用于发布。







9.2 Test methods测试方法

9.2.1   The quality control laboratory should use all test methods necessary to confirm that the product complies with acceptance criteria. 质量控制实验室应使用所有必要的测试方法以确认产品符合验收标准。







9.2.2    Controls should be performed on the basis of defined, appropriate and available test methods.控制的执行应基于制定的,适当的可行的测试方法上。







9.3 Acceptance criteria 验收标准

Acceptance criteria should be established to specify the requirements to be met for raw materials, packaging materials, bulk products and finished products.应建立验收标准,使得原材料,包装材料,散装产品和成品都应符合该标准。







9.4 Results结果

All results should be reviewed. After this review, a decision should be made, notably in terms of approval, rejection or pending对于所有的结果都应进行复查,复查后应作出相应的决定,特别是批准,拒绝或是延后。







9.5 Out-of-specification results检验偏差

9.5.1    Out-of-specification results should be reviewed by authorized personnel and properly investigated.检验偏差应由授权人员进行复查,并作出适当的调查。







9.5.2    There should be sufficient justification for any re-testing to be performed.对于任何测试的执行都应有充分的理由。







9.5.3   After the investigation, a decision by authorized personnel should be made, notably in terms of deviation, rejection or pending. 在复查后,授权人员应作出相应的决定,是批准,拒绝或是延后。







9.6 Reagent, solutions, reference standards, culture media化学试剂、解决方案、参考标准、培养基

Reagent, solutions, reference standards, culture media, etc. should be identified by the following information:化学试剂、解决方案、参考标准、培养基应确认如下信息:

a
the name;名称

b
its strength or concentration, when appropriate;应记录长度及浓度;

c
expiration data, when appropriate;有效期

d
the name and/or signature of the person who prepared it, when appropriate;应有准备人的名字或签名

e
opening date;开盖日期

f
storage conditions, when appropriate.储存条件







9.7 Sampling样本

9.7.1    Sampling should be performed by authorized personnel.采样应由授权人员操作







9.7.2    Sampling should be defined in terms of: 采集样本应确认下几点:

a
sampling method;采样方法

b
equipment to be used;适用器材

c
amounts to be taken;采集数量

d
any precautions to be observed to avoid contamination or deterioration;用以避免样本被污染或恶化的措施

e
identification of sample;样本识别

f
frequency.频次







9.7.3    Samples should be identified by:样本应根据以下几点进行确认

a
the name or identifying code;样本名称及代码

b
the batch number;批次号

c
the date of sampling;采样日期

d
the container from which the sample was taken;样品容器

e
the sampling point, if applicable.采样点







9.8 Retain sample样本保存

9.8.1    Samples of finished product should be retained in an appropriate manner and in designated areas.产成品的样本应使用正确的保存方法保留在制定的地方。







9.8.2    Sample size of finished products should allow analyses to be carried out in accordance with local regulations.产成品的样本大小应根据当地法规进行分析。







9.8.3    Retain samples of finished product should be kept in their primary package for an appropriate time under the recommended storage conditions.保留的产成品样本应将其放在原始包装内,使用正确的储存条件及适合的存放时间。







9.8.4    Samples of raw materials may be retained according to company practice or in accordance with local regulations.原材料样本应根据公司惯例或当地法规给予保存。










10 Treatment of product that is out of specification不合规产品处理

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10.1    Rejected finished products, bulk products, raw materials and packaging materials拒收产成品、散货、原材料及包装材料

10.1.1    Investigations of rejected product or materials should be performed by personnel authorized to do so.应由授权人员对拒收产品或拒收原材料情况进行调查。







10.1.2    Decisions to destroy or to reprocess should be approved by the personnel responsible for quality.应有质量负责人决定相关产品是销毁还是进行再生产加工。







10.2    Reprocessed finished products and bulk products产成品及散货再加工

10.2.1    If all or part of a batch of finished product or bulk product does not meet the defined acceptance criteria, a decision to reprocess in order to obtain the defined quality should be approved by personnel responsible for quality.如果全部或部分产成品及散货未达到验收标准,应由质量负责人确认再加工的质量标准。







10.2.2    The method of reprocessing should be defined and approved.应制定再加工方法并确认。







10.2.3    Controls should be performed on the reprocessed finished products or bulk products. Results should be reviewed by authorized personnel in order to verify the conformity of the finished product or bulk product with the acceptance criteria.应控制再加工的产成品及散货,相关结果应由授权人员再次核查以确认其产成品及散货符合验收标准。










11 Wastes废弃物

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11.1 Principle原则

Wastes should be disposed of in a timely and sanitary manner.废弃物应使用卫生手段及时处理







11.2 Types of waste废弃物类型

The company should define the different type of waste (from production and from the quality control laboratory ) that could affect the quality of the product.公司应定义可能影响产品质量的不同种类废弃物(如废弃物是来自生产过程或是质量控制实验室)







11.3 Flow流程

11.3.1    The flow of   waste should not impact on the production and laboratory operations.废弃物处理流程不应影响生产或实验室操作。







11.3.2    Appropriate measures should be taken concerning collection, transportation, storage and disposal of wastes.对于废弃物的收集,运输,储存及处理应有相应的措施。







11.4 Containers容器

Containers of waste should be properly identified as to contents and other information, as appropriate.装载废弃物的容器应将其装载废弃物的名称及相关信息标识出来。







11.5 Disposal处理

The disposal of waste should be performed in an appropriate way with an adequate level of control.应使用适当的方法处理废弃物且需要足够的管制水平。











12 Subcontracting分包

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12.1 Principle原则

A written contract or agreement should be established, mutually confirmed and controlled between the contract giver and the contract acceptor covering subcontracted activities. The objective of this step is to obtain a product or service that complies with the defined contract giver requirements.应制定一份双方都确认的成文合同或协议且合同双方都受制于合同所提及的分包工作。这一行为的目的是制作合同方得到合规的产品或服务。







12.2 Types of subcontracting分包类型

This clause concerns subcontracting of:分包应注意以下几项条款

a
manufacturing;制造商

b
packaging;包装

c
analysis;鉴定结果

d
cleaning, sanitization of premises;经营场所的卫生消毒情况

e
pest control;害虫防控

f
equipment and premises maintenance.设备及房屋维修







12.3 Contract giver 合同给方

12.3.1    The contract giver should assess the contract acceptor’s ability and capacity to carry out the contracted operations. Further, the contract giver should ensure that the contract acceptor has all the means available to carry out the contract. The contract giver should assess the contract acceptor’s ability to comply with these guidelines, as appropriate, and to ensure the operations can be performed as agreed.合同给方应评估合同受方的操作生产能力,另外,合同给方应确认合同受方履行合同的所有可用方式。合同给方还应视情况评估合同受方履行相应指南的能力以确保生产操作可以如约执行。







12.3.3    The contract giver should provide the contract acceptor with all the information required to carry out the operations correctly.合同给方应向合同受方告知所有正确操作的要求信息。







12.4 Contract acceptor合同受方

12.4. 1    The contract acceptor should ensure that they have the means, experience and competent personnel to meet the contract requirements.合同受方应确认自身有足够的方法,经验及人员以胜任合同上的所有要求







12.4.2     The contract acceptor should not pass to a third party any of the work entrusted to them in the contract without the contractor giver’s prior approval and consent. Arrangements should be made between the third party and the contract acceptor to ensure that all information about operations is made available to the contract giver in the same way as in the original contract.合同受方不可在没有得到合同给方的事先批准下将合同上的工作委托至第三方;合同受方与第三方签署的协议应确保所有的操作信息与合同给方所提供的合同/协议上的内容相一致。







12.4.3    The contract acceptor should facilitate any checks and audits that the contract giver has defined in the contract.合同受方应协助合同给方完成各项核查及审核。







12.4.4    The contract acceptor should inform the contract giver of any changes that may affect the quality of the services or products provided prior to implementation unless otherwise specified in the contract.如有任何会影响到服务或产品质量的变动,合同受方应提前告知合同给方,除非合同有另外的规定。







12.5 Contract 合同

12.5.1    A contract or agreement should be drawn up between the contract giver and the contract acceptor which specifies their respective duties and responsibilities.合同或协议应在合同给方及合同受方间起草并约定双方应履行的责任及义务。







12.5.2    All data should be kept or made available to the contract giver.所有的数据都应保留或提供给合同给方。










13 Deviations偏差

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13.1    Deviations from the specified requirements should be authorized with sufficient data to support the decision.对于特定要求的偏差应由足够的数据给予支持。







13.2    Corrective action should be made to prevent recurrence of the deviation.为防止偏差再次发生,应实行纠正行动措施。









14 Compliant and recalls投诉及召回

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14.1 Principle原则

14.1.1    All complaints that fall within the scope of these guidelines and are communicated to the plant should be reviewed, investigated and followed-up on, as appropriate.任何属于指南内的投诉都应告知工厂并进行核查,调查及后期跟进。







14.1.2    When a product recall decision is made, appropriate steps should be taken to complete the recall within the scope of these guidelines and to implement corrective action.如作出产品召回的决定,应采取适当的步骤完成指南范围内的召回程序并实施行动纠正计划。







14.1.3    In the case of contracted operations, the contract giver and acceptor should agree on the process for managing complaints (see 12.1)在承包经营的情况下,合同给方及合同受方应就投诉管理的过程达成共识。







14.2 Product complaints 产品投诉

14.2.1    Authorized personnel should centralise all complaints.授权人员应将所有投诉集中管理







14.2.2    Any complaints concerning a product defect should be kept with the original details and follow-up information.任何关于产品缺陷的投诉都应保留投诉原始细节及更新信息。







14.2.3    Appropriate follow-up on the concerned batch should be completed.应完成对于与投诉产品相关批次的其他产品的跟进程序。







14.2.4    Complaint investigations and follow-up should include:投诉调查及跟进应包含以下:

a
steps to prevent recurrence of the defect;防止缺陷再次发生的步骤。

b
checking other batches in order to determine whether they are also affected, where appropriate.检查其他批次产品以确认其他产品是否未受影响。







14.2.5    Complaints should be reviewed periodically to check for trends or recurrence of a defect.应定期核查各项投诉以确认趋势或确认再次发生的可能性。







14.3 Product recalls产品召回

14.3.1    The authorized personnel should coordinate the recall process.授权人员应协调召回程序。







14.3.2     Product recall operations should be capable of being initiated promptly and in a timely manner.产品召回程序应能够迅速及时的启动。







14.3.3    The appropriate authorities should be notified of recalls which could have an impact upon consumer safety.相关部门应通告有可能对消费者安全产生影响的召回程序。







14.3.4    Recalled products should be identified and stored separately in a secure area while awaiting a decision.召回后的产品应该做好标识并分开存放在安全区域,等待后续决策。







14.3.5    The product recall process should be periodically evaluated.应定期评估产品召回程序。










15 Change control变更控制

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Changes that could affect the quality of product should be approved and performed by authorized personnel on the basis of sufficient data.有可能影响产品质量的变更都应在有充分数据说明的情况下,由授权人员同意并执行。










16 Internal audit内部审核

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16.1 Principle原则

An internal audit is a tool which is designed to monitor the implementation and the status of these cosmetic Good Manufacturing Practices and , if necessary, to propose corrective actions.内部审核时用以实现监控产品良好生产规范的工具,如有必要还可提出纠正措施。







16.2 Approach 方法

16.2.1    Specially designated competent personnel should conduct internal audits in an independent and detailed manner, regularly or on demand.特别指定人员应定期或根据需要使用独立及详细的方案进行内部审核。







16.2.2    All observations made during the internal audit should be evaluated and shared with appropriate management.所有在内部审核时观察过得都应进行评估并告知管理层。







16.3 Follow-up跟进

Internal audit follow-up should confirm the satisfactory completion or implementation of corrective action.在内部审核完成后应确立一个完成的行动纠正计划。










17   Documentation文件

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17.1    Principle原则

17.1.1    Each company should establish, design, install and maintain its own system of documentation that is appropriate to its organizational structure and to the type of products. An electronic system can be used to prepare and manage documents.各个公司都应建立,设计,安装并维持适合其自身的组织结构及产品的文件系统,也可使用电子系统起草或管理文件。







17.1.2    Documentation is an integral part of Good Manufacturing Practices. Therefore, the objective of documentation is to describe activities defined in these guidelines in order to relate the history of these activities and to prevent risks of interpretation, loss of   information, confusion or errors inherent to verbal communication.文件编制是良好生产规范不可或缺的一部分,因此,文件编制的目的在于描述指南中的工作以便和相关的历史工作联系起来,又或是防止误解,丢失信息,混淆及内在的交流错误的发生。







17.2 Type of document文件类型

17.2.1    Document should be composed of constituents such as procedures, instructions, specifications, protocols, reports, methods, and records appropriate to the activities covered by these guidelines.文件应由指导方针上提及的工作的规程,说明,协议,报告,方法和记录组成。







17.2.2    Documents can be hard-copy papers or electronic data processing records.文档可由拷贝文档或电子数据处理记录下来。







17.3 Writing, approval and distribution起草,批准及发布

17.3.1   Documents should be defined and describe, with appropriate detail, the operations to be carried out,

precautions to be taken and measures to be applied in all activities connected with these guidelines. 文档应由指南内提及的工作的正确的细节,操作程序,预防措施及采取措施步骤等组成。







17.3.2    The title, nature and purpose of documents should be stated.应说明文档的标题,性质及目的。







17.3.3    Documents should be:文档应:

a
written in a legible and comprehensive way;以清晰及全面的方式起草

b
approved, signed and dated by authorized persons before being used;在落实前由授权人员批准并签署签名及日期。

c
prepared, updated, withdrawn, distributed, classified; 准备、更新、撤回、发布、分类;

d
referenced to ensure that obsolete documents are not used;确保不使用过期失效文档。

e
accessible to appropriate personnel;由正确的人员保管使用。

f
removed from the job area and destroyed if they are out-dated.已过期的文件应从工作区域移除并销毁。







17.3.4    Records which require the entry of handwritten data should:需手写的数据记录应包含以下:

a
indicate what is to be entered;说明登记的是什么

b
be written legibly with permanent ink;使用永不褪色墨水笔

c
be signed and dated;签署名字及日期

d
be corrected, if needed, leaving the original entry still readable; where appropriate, the reason for the correction should be recorded.如需纠正,原始信息也应被保留,如有需要,还应写明纠正原因。







17.4 Revision修正

Document should be updated, when necessary, and the revision number indicated.应定期更新文档,如有需要应标明修正编号。

The reason for each revision should be retained.应写明并保留修正文档的原因。







17.5 Archiving归档

17.5.1    Only original documents should be archived and only controlled copies should be used.应将原始文件归档存放使用而使用受控副本。







17.5.2    The duration of archiving original documents should be defined according to applicable legislation and regulations.应根据使用的法律法规对归档原始文件的时间做出规范。







17.5.3    The storage of original documents should be properly secured.应妥善保管储存的原始文档。







17.5.4    Documents may be archived as either electronic or hard-copies and their legibility should be ensured.文件可以使用电子版或硬件拷贝版归档,但不论何种方式都应确保其易读性。







17.5.5    Backup data should be stored at a separate and secure location at regular intervals.备份数据应定期储存在独立且安全的位置。









文章分类: ISO22716
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