The pharmaceutical Quality Unit has beenthe target of many FDA Warning Letters as the underlying cause of productquality and CGMP compliance problems. We have seen instances where the ultimate“no confidence” vote is cast when third-party experts are either recommended byFDA, or court ordered to take over their duties.
药品质量部门一直是许多FDA警告信中产品质量和CGMP合规问题的目标。我们已经看到，当FDA或法院命令推荐第三方专家时，最终投了"不信任"票。
Therefore, it’svery important to have a clear understanding of the regulatory responsibilitiesof the Quality Unit and to ensure that those responsibilities are effectivelyexecuted.
因此，必须清楚地了解质量部门的监管职责，并确保这些职责得到有效执行。
Remember—theQuality Unit is the only job description that appears in the Code of FederalRegulations!
请记住，质量部门是联邦法规中唯一有所描述的工作！
Here defines thejob of the Quality Unit.
以下描述质量部门的工作。
1. To establish the quality system
建立质量体系
Establish the quality management system to describe how the firm follows CGMPs and operates to maintain a state of control
建立质量管理体系，描述公司如何遵循 CGMP 并运营以保持控制状态
Keep the quality management system current with good industry practices
通过良好的行业实践保持质量管理体系与时俱进
2. To audit compliance to the qualitysystem
审查质量体系的遵守情况
Audit for compliance to policies and procedures: on paper vs. practice.
对政策和程序的遵守情况进行审查：书面审查或实际审查。
Report quality system performance metrics, including trends, that help decision-making and taking proactive targeted actions
报告质量体系性能指标（包括趋势），帮助决策并采取主动有针对性的措施
3. To establish procedures andspecifications
制定程序和标准
Ensure that procedures and specifications are appropriate and followed
确保程序和标准适当并得到遵循
Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.)
确保合同公司的程序和标准同样适当并得到遵循，例如保持控制并对第三方提供商（合同制造商、合同实验室等）负责
4. To establish manufacturing controls
建立生产控制
Ensure that appropriate manufacturing in-process controls are implemented
确保实施适当的生产过程控制
Ensure in-process controls are performed during manufacturing operations and results are satisfactory
确保在生产操作期间执行过程控制，并确保结果令人满意
5. To perform laboratory tests orexaminations
确保实验室测试或检查
Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications
确保使用基于科学的与其标准相适应的经验证的方法对组分、容器、中间产品、包装材料和成品进行实验室测试
Approve or reject drug products manufactured, processed, packed, or held under contract by another company, i.e., final product release is not delegated to a contractor.
批准或拒绝合同制造组织生产、加工、包装或保存的药品，即最终产品放行不委托给受托方。
Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions
对已批准的组分、药品容器和密封部件经长期存放或暴露于不利条件后，执行复检或复验。
6. To review and approve or reject allthings CGMP
审核、批准或拒绝 CGMP 范围内的所有内容
Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents
审核和批准/拒绝任何包含工作说明和设置要求的文件，如程序、方案、检验方法和标准，包括对这些文件的更改
Review and approve/reject reprocessing and rework procedures
审核和批准/拒绝重新加工和返工程序
Review and approve/reject production batch records and make the final decision to release a product lot into commerce.
审核和批准/拒绝生产批记录，并最终决定批产品是否可以销售。
7. To ensure investigation ofnonconformance
确保对不合格的调查
Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes
确保对生产和控制记录的错误、偏差和不合格（包括质量属性）的调查得到实施，并消除根本原因
Review complaints to determine if it relates to a failure to meet specification, if so investigate and report to FDA if it is serious and unexpected
审查投诉，以确定它是否与不合格有关，如果是，进行调查。如是严重和意外的，向药监局报告
8. To keep management informed
随时通知管理层
Report on product, process and system risks—and keep management informed
报告产品、工艺和系统风险，并随时向管理层通报
Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure—and keep management informed.
报告监管检查的结果，并确保答复完整并管理以使关闭可确认，并随时向管理层通报。
Keep management informed—get it?
随时向管理层通报—重要的事情说三遍
9. To describe responsibilities in writing
以书面形式描述责任
Have a complete and compliant procedure that describes responsibilities
建立完整且合规的程序，描述职责
Follow the procedure
遵循规程
10. To remainindependent
保持独立
Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities
确保监管责任与实际日常活动之间没有利益冲突
Be independent reviewer and approver with respect to manufacturing and process/ product development units
在生产和工艺/产品开发方面作为独立的审核者和批准者
Don’t drink the “Kool-Aid”
切勿偏听偏信
