ISO 22716: 2007 化妆品良好生产规范 中英文对照（成品、质量控制实验室）

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

8 Finished products 成品

8.1 Principle 原则

Finished products should meet the defined acceptance criteria. 

成品应符合相关的接收标准。

Storage, shipment and returns should be managed in a manner so as to maintain the quality of finished products. 

储存、运输和退货的管理应能保证成品质量。

8.2 Release 放行

8.2.1 Prior to being placed on the market, all finished products should be controlled in accordance with established test methods and should comply with acceptance criteria. 

投放市场之前，成品应按规定的试验方法进行控制并符合相关的接收标准。

8.2.2 Product release should be carried out by the authorized personnel responsible for quality.

只有经授权的质量负责人员才有权放行成品。

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. 

成品应在适宜的条件下存放于规定的区域内，储存适当的时间。储存过程中必要时应对成品实施监控。

8.3.2 Storage areas should permit organized storage. 

储存区域应整齐有序。

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.

放行、待处理或拒收的成品应分区存放，或采取其他有效措施避免混淆。

8.3.4 Identification of finished product containers should indicate: 

成品容器的标识应载明：

a) name or identifying code; 

名称或代码；

b) batch number; 

批号；

c) storage conditions when such information is critical to assure the quality of the product; 

与产品质量密切相关的储存条件；

d) quantity.

数量。

8.3.5 Measures should be set up to ensure stock turnover. 

应采取措施确保库存周转率。

Except in special circumstances, stock rotation should ensure that the oldest released stock is used first.

除特别情况，应采用先进先出的原则。

8.3.6 Periodic inventory checks should be performed to: 

应定期进行盘点，以确保：

a) ensure inventory accuracy; 

库存准确性；

b) ensure that acceptance criteria are met. 

符合接收标准。

Any significant discrepancy should be investigated.

应对重大差异进行调查。

8.4 Shipment 装运

Measures should be taken to ensure the shipment of the defined finished product. 

应采取措施确保成品按规定装运。

Precautions should be taken to maintain the finished product quality, when appropriate. 

适当时应采取预防措施保证成品质量。

8.5 Returns 退货

8.5.1 Returns should be identified in an appropriate way and stored in defined areas. 

退回的成品应明显标识并储存在指定的区域。

8.5.2 Returns need to be evaluated against established criteria to determine their disposition. 

应根据规定的标准评价退回的成品，以决定处理措施。

8.5.3 Release should be given before placing returns on the market again. 

退回的成品应经过放行才能重新投放市场。

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. 

应采取措施辨别返工的退货，避免因疏忽将未经放行的退货重新分销。

9 Quality control laboratory 质量控制实验室

9.1 Principle 原则

9.1.1 Principles described for personnel, premises, equipment, subcontracting, and documentation should apply to the quality control laboratory. 

人员、厂房、设备、分包和文件等部分所规定的原则同样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.

质量控制实验室负责在其活动范围内对抽样和试验实施必要的控制，以确保只有符合接收标准的物料才能放行使用、符合接收标准的产品才能放行装运。

9.2 Test methods 试验方法

9.2.1 The quality control laboratory should use all test methods necessary to confirm that the product complies with acceptance criteria. 

质量控制实验室应采用必要的试验方法确定产品符合接收标准。

9.2.2 Controls should be performed on the basis of defined, appropriate and available test methods.

应按规定采用适宜可行的试验方法实施控制。

9.3 Acceptance criteria 接收标准

Acceptance criteria should be established to specify the requirements to be met for raw materials, packaging materials, bulk products and finished products. 

应建立接收标准，规定原料、包装材料、半成品和成品应达到的要求。

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.

应对所有结果进行审查。审查后，应明确作出接受、拒绝或待定的结论。

9.5 Out-of-specification results 不合格结果

9.5.1 Out-of-specification results should be reviewed by authorized personnel and properly investigated. 

不合格结果应由经授权人员审查并进行适当的调查。

9.5.2 There should be sufficient justification for any re-testing to be performed. 

应有充分的理由方允许进行复验。

9.5.3 After the investigation, a decision by authorized personnel should be made, notably in terms of deviation, rejection or pending.

调查后，经授权人员应明确作出偏差、拒绝或待定的结论。

9.6 Reagents, solutions, reference standards, culture media 试剂、溶液、标准物质、培养基

Reagents, solutions, reference standards, culture media, etc. should be identified by the following information: 

试剂、溶液、标准物质和培养基等应做好标识，载明：

a) the name; 

名称；

b) its strength or concentration, when appropriate; 

浓度（适用时）；

c) expiration date, when appropriate; 

有效期限（适用时）；

d) the name and/or signature of the person who prepared it, when appropriate; 

配制人员姓名和（或）签名（适用时）；

e) opening date; 

开启日期；

f) storage conditions, when appropriate. 

储存条件（适用时）。

9.7 Sampling 抽样

9.7.1 Sampling should be performed by authorized personnel. 

应由经授权的人员负责抽样。

9.7.2 Sampling should be defined in terms of: 

抽样应规定：

a) sampling method; 

抽样方法；

b) equipment to be used; 

使用的设备；

c) amounts to be taken; 

抽样数量；

d) any precautions to be observed to avoid contamination or deterioration; 

防止污染或损坏的措施；

e) identification of sample; 

样品标识；

f) frequency. 

抽样频率。

9.7.3 Samples should be identified by: 

样品应标识：

a) the name or identifying code; 

名称或代码；

b) the batch number; 

批号；

c) the date of sampling; 

抽样日期；

d) the container from which the sample was taken; 

被抽样的容器；

e) the sampling point, if applicable. 

抽样点（适用时）。

9.8 Retain sample 留样

9.8.1 Samples of finished product should be retained in an appropriate manner and in designated areas. 

成品样品应在指定区域内用适当的方式保存。

9.8.2 Sample size of finished products should allow analyses to be carried out in accordance with local regulations.

成品留样数量应根据法规规定，满足分析检测的需要。

9.8.3 Retain samples of finished product should be kept in their primary package for an appropriate time under the recommended storage conditions. 

成品留样应保持内包装完好，在推荐的储存条件下保存适当的时间。

9.8.4 Samples of raw materials may be retained according to company practice or in accordance with local regulations.

原料的留样根据企业或相关法规的规定执行。