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.
藥品質量部門一直是許多FDA警告信中產(chǎn)品質量和CGMP合規(guī)問題的目標。我們已經(jīng)看到，當FDA或法院命令推薦第三方專家時，最終投了"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，必須清楚地了解質量部門的監(jiān)管職責，并確保這些職責得到有效執(zhí)行。
Remember—theQuality Unit is the only job description that appears in the Code of FederalRegulations!
請記住，質量部門是聯(lián)邦法規(guī)中唯一有所描述的工作！
Here defines thejob of the Quality Unit.
以下描述質量部門的工作。
1. To establish the quality system
建立質量體系
Establish the quality management system to describe how the firm follows CGMPs and operates to maintain a state of control
建立質量管理體系，描述公司如何遵循 CGMP 并運營以保持控制狀態(tài)
Keep the quality management system current with good industry practices
通過良好的行業(yè)實踐保持質量管理體系與時俱進
2. To audit compliance to the qualitysystem
審查質量體系的遵守情況
Audit for compliance to policies and procedures: on paper vs. practice.
對政策和程序的遵守情況進行審查：書面審查或實際審查。
Report quality system performance metrics, including trends, that help decision-making and taking proactive targeted actions
報告質量體系性能指標（包括趨勢），幫助決策并采取主動有針對性的措施
3. To establish procedures andspecifications
制定程序和標準
Ensure that procedures and specifications are appropriate and followed
確保程序和標準適當并得到遵循
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.)
確保合同公司的程序和標準同樣適當并得到遵循，例如保持控制并對第三方提供商（合同制造商、合同實驗室等）負責
4. To establish manufacturing controls
建立生產(chǎn)控制
Ensure that appropriate manufacturing in-process controls are implemented
確保實施適當?shù)纳a(chǎn)過程控制
Ensure in-process controls are performed during manufacturing operations and results are satisfactory
確保在生產(chǎn)操作期間執(zhí)行過程控制，并確保結果令人滿意
5. To perform laboratory tests orexaminations
確保實驗室測試或檢查
Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications
確保使用基于科學的與其標準相適應的經(jīng)驗證的方法對組分、容器、中間產(chǎn)品、包裝材料和成品進行實驗室測試
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.
批準或拒絕合同制造組織生產(chǎn)、加工、包裝或保存的藥品，即最終產(chǎn)品放行不委托給受托方。
Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions
對已批準的組分、藥品容器和密封部件經(jīng)長期存放或暴露于不利條件后，執(zhí)行復檢或復驗。
6. To review and approve or reject allthings CGMP
審核、批準或拒絕 CGMP 范圍內的所有內容
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
審核和批準/拒絕任何包含工作說明和設置要求的文件，如程序、方案、檢驗方法和標準，包括對這些文件的更改
Review and approve/reject reprocessing and rework procedures
審核和批準/拒絕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.
審核和批準/拒絕生產(chǎn)批記錄，并最終決定批產(chǎn)品是否可以銷售。
7. To ensure investigation ofnonconformance
確保對不合格的調查
Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes
確保對生產(chǎn)和控制記錄的錯誤、偏差和不合格（包括質量屬性）的調查得到實施，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
審查投訴，以確定它是否與不合格有關，如果是，進行調查。如是嚴重和意外的，向藥監(jiān)局報告
8. To keep management informed
隨時通知管理層
Report on product, process and system risks—and keep management informed
報告產(chǎn)品、工藝和系統(tǒng)風險，并隨時向管理層通報
Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure—and keep management informed.
報告監(jiān)管檢查的結果，并確保答復完整并管理以使關閉可確認，并隨時向管理層通報。
Keep management informed—get it?
隨時向管理層通報—重要的事情說三遍
9. To describe responsibilities in writing
以書面形式描述責任
Have a complete and compliant procedure that describes responsibilities
建立完整且合規(guī)的程序，描述職責
Follow the procedure
遵循規(guī)程
10. To remainindependent
保持獨立
Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities
確保監(jiān)管責任與實際日?；顒又g沒有利益沖突
Be independent reviewer and approver with respect to manufacturing and process/ product development units
在生產(chǎn)和工藝/產(chǎn)品開發(fā)方面作為獨立的審核者和批準者
Don’t drink the “Kool-Aid”
切勿偏聽偏信
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