ISO 22716: 2007 化妆品良好生产规范 中英文对照（范围、术语与定义）

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

1 Scope 范围

This International Standard gives guidelines for the production, control, storage and shipment of cosmetic products. 

本标准提供了化妆品生产、控制、储存和装运的指南。

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. 

本标准涉及产品质量方面，但不涉及工厂人员安全和环境保护。安全和环境保护是企业本身的责任，按地方法律法规监管。

These guidelines are not applicable to research and development activities and distribution of finished products. 

本标准不适用于研发和销售活动。

2 Terms and definitions 术语与定义

For the purposes of this document, the following terms and definitions apply. 

下列术语与定义适用于本标准。

2.1 acceptance criteria 接收标准

numerical limits, ranges, or other suitable measures for acceptance of test results 

作为试验结果接收依据的数值限量、范围或其他适当的方法。

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 

系统和独立的检查，以确定质量活动和相关结果是否符合计划安排、安排是否得到有效实施以及是否适合目标达成。

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 

由同一过程或同一系列过程生产的一定数量的相同的原料、包装材料或产品。

2.4 batch number 批号

distinctive combination of numbers, letters and/or symbols, which specifically identifies a batch 

用于识别“批”的一组数字、字母和（或）符号的组合。

2.5 bulk product 半成品

any product which has completed manufacturing stages up to, but not including, final packaging 

已完成制造过程，但未最后包装的产品。

2.6 calibration 校准

set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard

在规定条件下，将测量仪器或测量系统的测量值、物质的测量值跟相应参考标准的已知数值建立关联的一系列操作。

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 

为确保所有制造、包装、控制和储存的产品符合规定的接收标准，与良好生产规范所涉及的一项或多项活动的计划内变更相关的内部组织及职责。

2.8 cleaning 清洁

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 

确保清洁度和外观达到一定要求的所有操作，包括采用化学、机械、温度和时间等措施分离、去除表面可见的污垢。

2.9 complaint 投诉

external information claiming a product does not meet defined acceptance criteria 

声称产品不符合规定接收标准的外部信息。

2.10 contamination 污染

occurrence of any undesirable matter such as chemical, physical and/or microbiological matter in the product 

产品中出现化学、物理和（或）微生物等不符合要求的物质。

2.11 consumables 消耗品

materials such as cleaning agents and lubricants that are used up during cleaning, sanitization or maintenance operations 

在清洁消毒或维护中消耗的物质，如清洁剂和润滑油等。

2.12 contract acceptor 合同接受方

person, company or external organization carrying out an operation on behalf of another person, company or organization 

代表其他个人、公司或组织执行一项工作的个人、公司或外部组织。

2.13 control 控制

verification that acceptance criteria are met 

验证是否达到接收标准的要求。

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 

由于与良好生产规范所涉及的一项或多项活动相关的计划或非计划和临时性事件，造成内部组织及责任与规定要求出现偏离。

2.15 finished product 产品

cosmetic product that has undergone all stages of production, including packaging in its final container, for shipment 

已完成全部生产过程，包括装入最终容器，等待装运的化妆品。

2.16 in-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 

在生产过程中进行的控制，目的是为了监控并在适当情况下调整过程，以确保产品符合规定的接收标准。

2.17 internal audit 内部审核

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

由公司内部可胜任的人员进行系统的和独立的检查，旨在确定本标准所涉及活动以及相关结果是否符合计划安排、安排是否得到有效实施以及是否适合目标达成。

2.18 major equipment 主要设备

equipment specified in production and laboratory documents which is considered essential to the process 

生产和实验室文件中指定的关键设备。

2.19 maintenance 维护

any periodic or unplanned support and verification operations designed to keep premises and equipment in proper working condition 

定期或不定期的支持和验证，使厂房设施和设备处于正常工作状态。

2.20 manufacturing operation 制造过程

set of operations from the weighing of raw materials to the making of the bulk product 

从原料称重到制成半成品的一系列操作。

2.21 out-of-specification 不合格

examination, measurement or test result that does not comply with defined acceptance criteria 

检查、测量或试验结果不符合规定的接收标准。

2.22 packaging 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 

从半成品到成品所进行的所有包装步骤，包括充填、贴标签等。

2.23 packaging material 包装材料

any material employed in the packaging of a cosmetic product, excluding any outer packaging used for transportation 

化妆品包装使用的材料，不包括运输所用的外包装。

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：根据是否与产品直接接触，包装材料分为内包装材料和外包装材料。

2.24 plant 工厂

location for production of cosmetic products 

化妆品的生产场所。

2.25 premises 厂房和设施

physical location, buildings and supporting structures used to conduct receipt, storage, manufacturing, packaging, control and shipment of product, raw materials and packaging materials 

用于接收、储存、制造、包装、控制和装运产品、原料和包装材料的物理场所、建筑物和支撑结构。

2.26 production 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 

2.28 raw material 原料

any substance going into or involved in the manufacturing of a bulk product 

用于生产半成品的物质。

为确保产品符合接收标准所必需的所有计划内和系统的活动。

2.29 recall 召回 

decision made by a company to call back a product batch that has been put on the market

公司收回已投放市场的产品的决定。

2.30 reprocessing 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 

对某生产阶段产生的不合格成品或半成品的整批或部分进行再处理，通过一项或多项措施使其质 量符合要求。

2.31 return 退货

sending finished cosmetic products which may or may not present a quality defect back to the plant 

将存在或不存在质量缺陷的成品退回工厂。

2.32 sample 样品

one or more representative elements selected from a set to obtain information about that set 

从某一系列内选择一个或多个代表性元素，以获得该系列有关信息。

2.33 sampling 抽样

set of operations relating to the taking and preparation of samples 

与取样和制样相关的一系列操作。

2.34 sanitization 消毒

operation, used to reduce undesirable micro-organisms on inert contaminated surfaces depending on the objectives set 

减少被污染的惰性表面的微生物的操作。

NOTE It is the action of reducing generally invisible contaminants from a surface. 

注：该行为通常是减少表面不可见的污染物。

2.35 shipment 装运

set of operations relative to the preparation of an order and its putting in a transport vehicle 

与定单准备和装载进运输工具相关的一系列操作。

2.36 waste 废弃物

any residue of a production operation, transformation or use, any substance, material, product that its holder intends for disposal

产品生产、转运或使用的残留物质以及待丢弃的任何物质、材料和产品