ISO 22716: 2007 化妆品良好生产规范 中英文对照（不合格品处理、废弃物、转包合同）

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

10 Treatment of product that is out of specification 不合格品处理

10.1 Rejected finished products, bulk products, raw materials and packaging materials 拒绝的成品、半成品、原料和包装材料

10.1.1 Investigations of rejected product or materials should be performed by personnel authorized to do so. 

应由经授权人员对拒绝的成品或物料进行调查。

10.1.2 Decisions to destroy or to reprocess should be approved by the personnel responsible for quality. 

应由质量负责人员做出销毁或返工的决定。

10.2 Reprocessed finished products and bulk products 返工的成品和半成品

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. 

如果一个批次的成品或半成品全部或部分不符合接收标准，通过返工使其符合质量要求的决定应得到质量负责人员的批准。

10.2.2 The method of reprocessing should be defined and approved.

返工的方法应予以规定并得到批准。

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.

应对返工的成品和半成品予以控制。应由经授权人员对结果进行审查，以验证成品或半成品是否符合接收标准。

11 Wastes 废弃物

11.1 Principle 原则

Wastes should be disposed of in a timely and sanitary manner. 

废弃物的处理应及时、卫生。

11.2 Types of waste 废弃物类型

Using findings from production and quality control laboratories, the company should define the different types of waste that could affect the quality of the product. 

应确定生产过程及质量控制实验室所产生的可能影响产品质量的各种废弃物类型。

11.3 Flow 流向

11.3.1 The flow of waste should not impact on the production and laboratory operations. 

废弃物的流向不应对生产和实验室操作造成影响。

11.3.2 Appropriate measures should be taken concerning collection, transportation, storage and disposal of wastes. 

应采取适当的措施收集、运输、储存和处置废弃物。

11.4 Containers 容器

Containers of waste should be properly identified as to contents and other information, as appropriate. 

应根据内容物和其他情况对废弃物的容器加以标识。

11.5 Disposal 处置

The disposal of waste should be performed in an appropriate way with an adequate level of control.

废弃物的处置应采用适当的方法并进行充分的控制。

12 Subcontracting 转包合同

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.

合同提供方与合同接受方应就转包事项共同确认和控制，并签订书面合同或协议，以确保合同接受方所提供的产品或服务符合合同提供方的要求。

12.2 Types of subcontracting 转包类型

This clause concerns subcontracting of: 

转包包括以下事项：

a) manufacturing; 

制造；

b) packaging; 

包装；

c) analysis; 

分析；

d) cleaning, sanitization of premises; 

厂房设施的清洁消毒；

e) pest control; 

虫害控制；

f) equipment and premises maintenance. 

设备和厂房设施的维护。

12.3 Contract giver 合同提供方

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. 

合同提供方应评估合同接受方履行合同的能力，确保合同接受方具备履行合同的所有方法。适当时，合同提供方应评估合同接受方遵循本指南的能力，确保合同的执行按协议进行。

12.3.2 The contract giver should provide the contract acceptor with all the information required to carry out the operations correctly.

合同提供方应向合同接受方提供正确操作所需要的所有信息。

12.4 Contract acceptor 合同接受方

12.4.1 The contract acceptor should ensure that they have the means, experience and competent personnel to meet the contract requirements. 

合同接受方应确保具备方法、经验和能胜任的人员以满足合同的要求。

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.

除非得到合同提供方的批准和同意，否则合同接受方不得将合同规定的任何活动再转包给第三方。第三方和合同接受方应确保合同提供方能够以原来合同规定的方式获得所有信息。

12.4.3 The contract acceptor should facilitate any checks and audits that the contract giver has defined in the contract. 

合同接受方应对合同提供方按照合同规定进行的检查和审核提供便利。

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. 

除非合同另有规定，合同接受方在实施之前应将可能影响到所提供的产品或服务质量的任何变化通知合同提供方。

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. 

合同提供方和合同接受方应签订书面合同或协议，明确双方的义务和职责。

12.5.2 All data should be kept or made available to the contract giver.

所有的资料应保存，确保合同提供方能获取。