ISO22716标准（中英文对照）

1 INTERNATIONA STANDARD L 国际标准 ISO22716 First edition 2007-11-15 第一版本发行于 2007 年 11 月 15 日 Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices 化妆品—良好生产规范（GMP）准则 ISO 22716:2007(E) 标准号 ISO22716:2007(E) 2 Contents Page Introduction ............................................................................................................................ 1 1 Scope .................................................................................................................................. 1 2 Terms and definitions ........................................................................................................... 1 3 Personnel............................................................................................................................ 4 4 Premises .............................................................................................................................. 6 5 Equipment ............................................................................................................................ 8 6 Raw materials and packaging materials ......................................................................... 10 7 Production......................................................................................................................... 11 8 Finished products.............................................................................................................. 14 9 Quality control laboratory................................................................................................. 15 10 Treatment of product that is out of specification.......................................................... 17 11 Wastes .............................................................................................................................. 17 12 Subcontracting................................................................................................................. 18 13 Deviations......................................................................................................................... 19 14 Complaints and recalls ............................................................................................... 19 15 Change control................................................................................................................ 19 16 Internal audit ................................................................................................................... 20 17 Documentation................................................................................................................ 20 3 目录 介绍 .......................................................................1 1 范围 ..................................................................... 1 2 术语和定义.................................................................1 3 员工...................................................................... 4 4 厂房 ......................................................................6 5 设备 ......................................................................8 6 原料和包材 ................................................................10 7 生产.......................................................................11 8 成品.......................................................................14 9 实验室质量控制制.......................................................... 15 10 不合格品的处理.......................................................... .17 11 废弃物................................................................... 17 12 外包..................................................................... 18 13 偏差..................................................................... 19 14 投诉和召回............................................................... 19 15 变更控制................................................................. 19 16 内审 .................................................................... 20 17 文档..................................................................... 20 4 Introduction These guidelines are intended to provide guidance regarding Good Manufacturing Practices for cosmetic products. These guidelines have been prepared for consideration by the cosmetic industry and take into account the specific needs of this sector. These guidelines offer organizational and practical advice on the management of the human, technical and administrative factors affecting product quality. These guidelines have been written to allow them to be used following the flow of products from receipt to shipment. Additionally, in order to clarify the way this document reaches its objectives, a ‘principle’ is added to each major section. Good Manufacturing Practices constitute the practical development of the quality assurance concept through the description of the plant activities that are based on sound scientific judgement and risk assessments. The objective of these GMP guidelines is to define the activities that enable you to obtain a product that meets defined characteristics. Documentation is an integral part of Good Manufacturing Practices. 介 绍 这份准则为化妆品良好生产规范做出指导，是适合化妆品行业并考虑了行业的具体要求，在人 员，技术和影响产品质量的综合因素方面提供了系统性的和实际性的建议。 这个指导是为了让员工遵守产品接收到装运的 流程 快递问题件怎么处理流程河南自建厂房流程下载关于规范招聘需求审批流程制作流程表下载邮件下载流程设计 下如何去利用资源。为了达到此目的，在每 一个章节里都添加了“原则”这一栏。 良好生产规范中的质量保证发展观念是通过描述建立在科学有效的判定和风险评估上的工厂活 动来完成的，这份准则的目的是为了界定能让你获得达标产品的活动。 文件是 GMP 不可或缺的一部分。 5 ISO22716:2007(E) 化妆品良好生产规范准则 1 Scope 范围 This International Standard gives guidelines for the production, control, storage and shipment of cosmetic products 此国际标准为化妆品生产，控制，储存和装运提供指南 These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the personnel engaged in the plant, nor do they cover aspects of protection of the environment. Safety and environmental aspects are inherent responsibilities of the company and could be governed by local legislation and regulation. 这个标准包含产品质量的各个方面但不包括员工安全和对环境的保护方面，安全和环境保护是公司的应的责任，可 以通过当地的法律和法规加以管制 These guidelines are not applicable to research and development activities and distribution of finished products. 这些准则并不适用于设计和开发和产品营销活动。 2 Terms and definitions 术语和定义 For the purposes of this document, the following terms and definitions apply. 以下术语和定义对于本文件是适用的 2.1 acceptance criteria 接收标准 numerical limits, ranges, or other suitable measures for acceptance of test results 数值限度，范围或者其他可作为接受测试结果的方法 2.2 audit 审核 systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives 为获得审核证据并对其进行客观评价，以确定满足审核准则的程度而进行的 系统的、独立的、形成文件的过程。 2.3 Batch 批 defined quantity of raw material, packaging material or product issued from one process or series of processes so that it could be expected to be homogeneous 从某个或多个操作获得的、认为是一致的特定数量的原料，包材或产品。 2.4 batch number 批号 distinctive combination of numbers, letters and/or symbols, which specifically identifies a batch 单个数字，字母，或字母和数字结合的，用来指定识别一批产品的代码. 2.5bulk produc 散装产品 any product which has completed manufacturing stages up to, but not including, final packaging 经过所有制造工艺过程的产品，除了没有填充到独立包装的产品。 2.6Calibration 校准 set of operations that establish, under specified conditions, the relationship between values indicated by a measuring 6 instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard 在特定条件下，通过一系列操作在测量仪器或测量系统所指示的量值，或事物量具或参考事物表示的值，和按标准 实现的相应值间建立起一种关系。 2.7 change control 变更控制 internal organization and responsibilities relative to any planned change of one or several activities covered by the Good Manufacturing Practices in order to ensure that all the manufactured, packaged, controlled and stored products correspond to the defined acceptance criteria 为确保生产，包装，控制，储存符合接收标准，组织所作的内部机构、职责与 GMP 内容有关的任何 计划 项目进度计划表范例计划下载计划下载计划下载课程教学计划下载 的变动。 2.8Cleaning 清洗 all operations that ensure a level of cleanliness and appearance, consisting of separating and eliminating generally visible dirt from a surface by means of the following combined factors, in variable proportions, such as chemical action, mechanical action, temperature, duration of application 为确保达到洁净水平，隔离或消除表面赃物的所有操作。例如用化学作用，机械作用，温度，时间等方法。 2.9Complaint 投诉 external information claiming a product does not meet defined acceptance criteria 外部信息断言成品有质量缺陷。 2.10Contamination 接触污染 occurrence of any undesirable matter such as chemical, physical and/or microbiological matter in the product 指在产品中发现任何不应出现化学的，物理的，生物的物质的事件。 2.11Consumables 耗材 materials such as cleaning agents and lubricants that are used up during cleaning, sanitization ormaintenance operations 指某些在清洁、消毒或维护中消耗的材料诸如清洁剂、润滑油等。 2.12contract acceptor 受托方 person, company or external organization carrying out an operation on behalf of another person, company or organization 代表某人、公司、组织实施操作的个人、公司或外部的组织。 2.13 Control 控制 verification that acceptance criteria are met 确认可接受准则得到满足 2.14 Deviation 偏差 internal organization and responsibilities relative to the authorization to deviate from specified requirements due to a planned or unplanned and, in any case, temporary situation concerning one or several activities covered by the Good Manufacturing Practices 由于计划的或非计划的临时情况，组织和职责偏离了 GMP 所覆盖的一个或多个活动的特定要求。 2.15finished product 成品 cosmetic product that has undergone all stages of production, including packaging in its final container, for shipment 7 化妆品产品经历了所有的生产阶段，包括在其最后的容器包装，出货。 2.16in-process control 过程控制 controls performed during production in order to monitor and, if appropriate, to adjust the process to ensure that the product meets the defined acceptance criteria 对生产过程进行监控，如果需要可对过程进行调整以确保产品达到可接受准则。 2.17internal audit 内审 systematic and independent examination made by competent personnel inside the company, the aim of which is to determine whether activities covered by these guidelines and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives 由内部有能力的人员实施的系统和独立的检查，目的是为了确定活动是否覆盖了与指南和策划的相关结果，以及这 些安排是否得到有效实施并适用于实现目标。 2.18major equipment 主要设备 equipment specified in production and laboratory documents which is considered essential to the process 在生产和实验室文件中详细说明的，被认为是对加工必不可少的设备 2.19Maintenance 维护 any periodic or unplanned support and verification operations designed to keep premises and equipment in proper working condition 为了保持房屋和设备处于适宜的工作状态所实施的定期或非计划的维护和验证检查。 2.20manufacturing operation 制造过程 set of operations from the weighing of raw materials to the making of the bulk product 从原料的称量到散装产品的制造必走的过程 2.21out-of-specification 超出规格 examination, measurement or test result that does not comply with defined acceptance criteria 检查，测量或测试的结果不符合规定的可接收标准 2.22packaging operation 包装过程 all packaging steps including filling and labelling, which a bulk product has to undergo in order to become a finished product 所有包装步骤包括填充，就是散装产品到成品必走的过程 2.23packaging material 包材 any material employed in the packaging of a cosmetic product, excluding any outer packaging used for transportation 任何 用于包装产品的包装材料，除了用于运输的外包装 NOTE Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.注意：包材可分为第一和第二材料根据它们是否与产品直接接触 2.24Plant 工厂 location for production of cosmetic products 化妆品厂的位置。 2.25Premises 厂房 physical location, buildings and supporting structures used to conduct receipt, storage, manufacturing, packaging, control and shipment of product, raw materials and packaging materials 8 物理位置，建筑物和支撑结构，用于实施接收，储存，制造，包装，控制和产品，原料，包材运输等活动 2.26production 生产 manufacturing and packaging operations 制造和包装过程 2.27 quality assurance 质量保证 all those planned and systematic activities necessary to provide confidence that a product satisfies given acceptance criteria 为了确保产品符合标准所进行的计划和系统的活动。 2.28raw material 原料 any substance going into or involved in the manufacturing of a bulk product 制造一个散装产品所引入的或有关的物质 2.29Recall 召回 decision made by a company to call back a product batch that has been put on the market 决定从市场上回收某个批次的产品。 2.30Reprocessing 返工 re-treatment of all or part of a batch of finished product or bulk product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations 对确定生产阶段的所有或部分不合格成品或散装产品重新加工以让其允收。 2.31Return 返回 sending finished cosmetic products which may or may not present a quality defect back to the plant 将可能有或没有质量缺陷的成品退回工厂。 2.32Sample 样品 one or more representative elements selected from a set to obtain information about that set 从一批里选择出的一个或多个具有典型要素的，可以获得那批信息的产品 2.33Sampling 抽样 set of operations relating to the taking and preparation of samples 操作中涉及选择和准备样品的活动。 2.34Sanitization 消毒 operation, used to reduce undesirable micro-organisms on inert contaminated surfaces depending on the objectives set NOTE It is the action of reducing generally invisible contaminants from a surface 在钝化的被污染的表面实施的操作，目的是减少不良微生物。 注：它是一个减少通常不可见的污染的操作。 2.35Shipment 装运 set of operations relative to the preparation of an order and its putting in a transport vehicle 有关订单的准备和装入运输工具的一系列行为。 2.36Waste 废弃物 any residue of a production operation, transformation or use, any substance, material, product that its holder intends for 9 disposal 生产过程产生的或转化而成的，或者使用后的原料，产品等需要废弃的任何物质。 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 医疗器械组织机构图医疗器械组织机构公司组织结构框架图公司组织机构图怎么做公司组织机构设置要求 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 3.2.1.2 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，每个公司应确保在活动的不同范围都有充足的员工 3.2.1.3 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 All 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 10 e) be encouraged to report irregularities or other non-conformities which may occur at the level of their responsibilities;被 鼓励 报告 软件系统测试报告下载sgs报告如何下载关于路面塌陷情况报告535n,sgs报告怎么下载竣工报告下载 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 3.4.2.1 Appropriate 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 3.4.2.2 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.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 external organizations, if necessary.根据需要和现有的可利用资源，培训课程可 由公司自己编制或由外部专业人士编写 3.4.2.5 Training should be regarded as a constant and on-going process that is subject to regular updates. 培训应该是持续的并能及时更新 3.4.3 Newly recruited personnel 新员工招聘 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. 除了基本的理论和 GMP 培训，新员工还要他们岗位的培训 3.4.4 Personnel training evaluations 个人培训评估 Knowledge accumulated by personnel should be evaluated during and/or after training .在培训过程中或者过后，个人知识的积累需进行评估 3.5 Personnel hygiene and health 个人卫生和健康 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. 就建立卫生程序并满足工厂的需要，在生产，控制，储存区域工作的人员要理解这些要求并且遵守 3.5.1.2 Personnel should be instructed to use hand washing facilities .每个人要被指导如何使用洗手设备 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，储存区域人员要穿好防护衣从而避免污染产品 11 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，储存区域吃东西、喝水、吃口香糖、抽烟、储存食物，个人药品。 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 .任何不卫生的行为都不能出现在生产，控制，储存区域或