ISO 22716: 2007 化妆品良好生产规范 中英文对照（偏差、投诉和召回、更改控制、内部审核、文件）（完结）

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

13 Deviations 偏差

13.1 Deviations from the specified requirements should be authorized with sufficient data to support the decision. 

背离规定要求的偏差应具有充分的资料以供做出决定。

13.2 Corrective action should be made to prevent recurrence of the deviation. 

应采取纠正措施，防止偏差再发生。

14 Complaints and recalls 投诉和召回

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. 

工厂收到的本标准范围内的所有投诉应予以评审、调查和适当跟进。

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.

一旦做出产品召回决定，应采取适当措施完成本标准范围内的召回事宜，并采取纠正措施。

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). 

若有转包事宜，合同提供方和合同接受方应在产品投诉管理方面达成一致（见１２.１）。

14.2 Product complaints 产品投诉

14.2.1 Authorized personnel should centralise all complaints. 

应由经授权人员集中管理所有的投诉事宜。

14.2.2 Any complaints concerning a product defect should be kept with the original details and follow-up information. 

涉及产品缺陷的投诉应保留最初详情以及后续处理措施的资料。

14.2.3 Appropriate follow-up on the concerned batch should be completed. 

应对投诉涉及批次的产品采取适当的跟进措施。

14.2.4 Complaint investigations and follow-up should include: 

投诉的调查与跟进应包括：

a) steps to prevent recurrence of the defect; 

防止缺陷再发生的措施；

b) checking other batches in order to determine whether they are also affected, where appropriate. 

适用时，检查其他批次的产品是否受到影响。

14.2.5 Complaints should be reviewed periodically to check for trends or recurrence of a defect. 

应定期对投诉进行分析，检查缺陷发生的趋势或再发生的情况。

14.3 Product recalls 产品召回

14.3.1 The authorized personnel should coordinate the recall process. 

产品召回应由经授权人员进行协调处理。

14.3.2 Product recall operations should be capable of being initiated promptly and in a timely manner.

产品召回的启动应迅速、及时。

14.3.3 The appropriate authorities should be notified of recalls which could have an impact upon consumer safety. 

应将可能影响到消费者安全的召回事件报告主管部门。

14.3.4 Recalled products should be identified and stored separately in a secure area while awaiting a decision. 

召回的产品应有明显的标识，储存于独立安全的区域等待处理。

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 更改控制

Changes that could affect the quality of product should be approved and performed by authorized personnel on the basis of sufficient data.

任何可能影响产品质量的更改应基于充分的数据并由经授权人员批准和实施。

16 Internal audit 内部审核

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. 

内部审核是用于监控良好生产规范的实施和状况，必要时建议采取纠正措施的工具。

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. 

专门指定的能胜任的人员应定期或根据需要进行独立和详细的内部审核。

16.2.2 All observations made during the internal audit should be evaluated and shared with appropriate management. 

内部审核所有的审核发现应予以评估并汇报管理层。

16.3 Follow-up 跟进

Internal audit follow-up should confirm the satisfactory completion or implementation of corrective action. 

内部审核的跟进应确认纠正措施得到完成或实施。

17 Documentation 文件

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. 

企业应根据组织结构和产品类型建立、设计、安装并维护文件系统。可以使用电子系统编制和管理文件。

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.

文件是良好生产规范的组成部分。文件的目的是为了描述本标准规定的活动，以保持以往活动的可追溯性，并且防止语言沟通本身所带来的阐释、信息丢失、混淆或错误等风险。

17.2 Type of document 文件类型

17.2.1 Documents should be composed of constituents such as procedures, instructions, specifications, protocols, reports, methods, and records appropriate to the activities covered by these guidelines. 

 文件应包含与本标准所涉及活动相关的程序文件、作业指导书、标准、方案、报告、方法和记录等。

17.2.2 Documents can be hard-copy papers or electronic data processing records. 

文件可以是纸质文件或电子文本。

17.3 Writing, approval and distribution 编写、批准和发放

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. 

文件应详细规定并描述相关操作、预防措施以及应用于与本标准相关的所有活动的措施。

17.3.2 The title, nature and purpose of documents should be stated. 

应写明文件的名称、种类和编写的目的。

17.3.3 Documents should be: 

文件应：

a) written in a legible and comprehensive way; 

清晰易读，易于理解；

b) approved, signed and dated by authorized persons before being used; 

使用前应由经授权人员批准、签发并注明日期；

c) prepared, updated, withdrawn, distributed, classified; 

编制、更新、回收、发放和分类；

d) referenced to ensure that obsolete documents are not used; 

确保不使用作废文件；

e) accessible to appropriate personnel; 

确保使用人员可获得；

f) removed from the job area and destroyed if they are out-dated.

过期文件应从工作区域撤走并销毁。

17.3.4 Records which require the entry of handwritten data should: 

手写的记录应：

a) indicate what is to be entered; 

写明所记录的内容；

b) be written legibly with permanent ink; 

用不易褪色的墨水清晰书写；

c) be signed and dated; 

签名并注明日期；

d) be corrected, if needed, leaving the original entry still readable; where appropriate, the reason for the correction should be recorded. 

记录内容如有修改，应使原文仍可辨认。适用时，应记录更改理由。

17.4 Revision 修订

Documents should be updated, when necessary, and the revision number indicated. 

必要时应对文件进行更新，并标明修订版本。

The reason for each revision should be retained. 

应保留每次修订的理由。

17.5 Archiving 归档

17.5.1 Only original documents should be archived and only controlled copies should be used. 

只有文件原件应予以归档，只能使用受控文件。

17.5.2 The duration of archiving original documents should be defined according to applicable legislation and regulations.

应根据适用的法律法规规定文件原件的保存期。

17.5.3 The storage of original documents should be properly secured.

文件原件的保存应确保安全。

17.5.4 Documents may be archived as either electronic or hard-copies and their legibility should be ensured.

归档的文件可以是电子文本或纸质文件，应确保易于辨认。

17.5.5 Backup data should be stored at a separate and secure location at regular intervals.

备份的资料应定期储存在独立、安全的地方。