4.1 Understanding the Organisation and its context

组织及组织环境的理解

Are external and internal issues concerning Cosmetic Ingredients (CI) Identified?

是否已识别组织内外部有关于化妆品成分的事项？

Are these reflected in the organization of QMS and GMP?

这些环境因素是否在实施QMS和GMP时体现？

Are issues reviewed and in particular is relevant legislation monitored for changes that may affect CI?

是否对可能影响化学品成分的相关监督法规进行评审？

4.2 Understanding the needs and expectations of interested Parties

了解利益相关方的需求和期望

Are interested parties and their requirements identified?

是否识别利益相关方和他们的要求？

Is there active monitoring for changes relevant to the requirements for CI?

是否对化学品成分要求的变更进行活动监控？

Are customers and regulatory authorities and their

requirements identified?

是否已识别客户和监管机构以及他们的要求？

Are users of cosmetics identified as an interested party?

化妆品使用者是否被定义为利益相关方？

4.3 Determining the Scope of the Quality Management System

定义质量管理体系的范围

Does the scope of the organizations GMP fall completely within the scope of the certified ISO 9001 system?

组织GMP的范围是否完全包含在已认证的ISO9001体系范围内？

Does the scope of the organization’s GMP include a list of activities, facilities and CI groups or CIs?    组织GMP的范围是否包括了一系列的活动、设施和化学品成分？

Is the scope of the organisations GMP and QMS defined and controlled as documented information?组织定义的GMP和QMS范围是否形成文件化信息？

Does the organisation only distribute CIs?, If yes then check with Appendix F to ensure the exempted clauses are correctly applied.

组织是否仅生产化学品成分？如果是，请根据附录F检查确认豁免条款是否适用。

4.4 Quality Management System and its Processes

质量管理体系和过程、EFfCI GMP 审核清单

4.4.1 i

Are methods, including criteria, specified to ensure the organisation can fulfil the requirements of GMP requirements and effective implementation?

是否有规定的方法（包括准则），以确保机构符合GMP规定的要求以及有效实施？

4.4.1j

Are all manufacturing processes, all testing and all other operations required to control and that effect CI quality included within the QMS?

QMS是否包含所有受控和影响化妆品成分质量的制造、检测和其他操作？

4.4.1k

Are any operations outsourced?

是否存在过程外包？

Are they included in the organisations QMS?

是否包含在组织的QMS中？

Is there evidence that GMP principles are followed in outsourced operations?

是否有证据证明外包过程遵循了GMP原则？

See section 8.4

见8.4

5 LEADERSHIP

领导

5.1.1k and 5.2.1e

Is there a well-publicised Quality Policy. Is it signed/authorized by top management? Does it include statements on the importance and relevance of GMP?

是否有已发布的质量方针？是否经由最高管理层签字/批准？是否包含GMP重要性和相关性的陈述？

5.1.1l

Are Quality Objectives set? Do these include GMP related objectives and adherence to GMP as an objective?

Are the performance against objectives measured, reviewed and objectives revised at an appropriate frequency?

组织是否建立了质量目标？这些目标是否包含GMP相关目标以及遵循GMP目标？

5.1.1.m

Have resources been explicitly identified for GMP quality system and for achievement of each quality objective?

是否明确识别GMP质量体系以及实现各质量目标的资源？

5.1.2

How is meeting customer requirements and meeting GMP requirements promoted and monitored by top management？

如何满足客户要求，以及由最高管理者提出并监控的GMP要求？