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1、【純干貨】PDA TR49 生物制品清潔驗證考慮要點(中英文版)節選1(1.0-2.0)

2、【純干貨】清潔程序的設計與開發(中英文版)(PDA TR 49內容節選)

3、【純干貨】清潔驗證可接受限度(中英文版)(PDA TR 49內容節選3)

4、【純干貨】清潔驗證可接受限度-下(中英文版)(PDA TR 49內容節選4)

5、【純干貨】清潔驗證之取樣方法(PDA TR 49內容節選5 中英文版)

6、【純干貨】清潔驗證之分析方法-上(PDA TR 49內容節選6 中英文版)

7、【純干貨】清潔驗證之分析方法-下(PDA TR 49內容節選7 中英文版)

8、【純干貨】清潔驗證方案(PDA TR 49內容節選8?中英文版)9、【純干貨】驗證狀態維護(PDA TR 49內容節選9 中英文版)10、純干貨】總體規劃清潔驗證(PDA TR 49內容節選10 中英文版)10.0 Risk assessment and Management風險評估和管理Quality Risk Management (QRM) is a readily applied and logical process that iseffectively used to support the?planning and strategy for maintaining a system or a process under continuous quality oversight. The many?benefits of a quality risk management process include, but are not limited to:Improved planning and preparation to prevent potential failures

• Increased understanding of the critical aspects of systems, processes and products

• Improved stakeholder relationships through better communication

• Increased levels of assurance through documentation of the decision-making process

• Reduced risk to patients by modifying processes to eliminate or reduce risk

• Improved detectability of fault conditions

• Optimization and prioritization of qualification efforts and resources

• Selection of test methods and acceptance criteria which are aligned with critical quality attributes of products

• Compliance with regulatory requirements or expectations

• Assistance in maintaining processes in a state of control

質量風險管理(QRM)是一個便于應用且合理的流程，它能有效地支持計劃和策略，使系統或工藝維持在連續的質量監督下。質量風險管理有許多優點，但不局限于以下幾點：改進計劃、預防潛在失誤

• ??增進對系統、工藝和產品關鍵方面的理解

• ? 通過更好的溝通改善利益雙方關系

• ? 通過對決策流程的記錄提高保障水平

• ? 通過改進工藝消除或減少風險，降低給患者帶來的風險

• ? 提高故障檢測性

• ? 優化驗證資源

• ? 選擇檢測方法和可接受標準，同產品關鍵質量屬性一致

• ? 符合法規要求或期望

• ? 使工藝維持在受控狀態

The role of risk management is integral to the design and validation strategy for manufacturing systems. Risk?management is a continuous process. Key inputs and data are analyzed and evaluated, and risk mitigation?measures are implemented to ensure the outputs of the design are appropriately considered and verified,?and that the subject system is demonstrated as fit for purpose. Cleaning and cleaning validation?requirements are determined from inputs related to the knowledge of process systems, soils and equipment?cleaning aids (e.g., chemical and mechanical features). These requirements are subject to a design review?and then verified in accordance with the acceptance criteria that are used to prove that the system?requirements have been achieved.Product knowledge, process knowledge, regulations and quality attributes are used to develop the?requirements for cleaning and to define the technologies that will best support the cleaning of?manufacturing systems and components. Issues that may impact cleaning include: soil type, cleaning process,?equipment design and configuration and availability of utility services. Process knowledge is used to?determine CPPs and define CQAs. Examples of each are presented in Table 10.1 below.Table 10.1 CPP and CQA Considerations that have Potential Risk Impact to a Cleaning Process風險管理貫穿于生產系統整個設計和驗證策略。風險管理是一個連續的過程。分析和評估關鍵的投料量和數據，采取風險緩解措施確保設計合理有效，證明目標系統符合預期用途。清潔和清潔驗證要求由工藝系統、臟物和設備清潔相關(如化學和機械特性)的知識來確定。這些要求要通過設計審核，然后證實符合可接受標準，該可接受標準用于證明系統要求已經達根據產品知識、工藝知識、法規和質量屬性確定清潔要求，規定能夠最好支持清潔生產系統和組分的方法。可能影響清潔的問題包括：臟物類型、清潔程序、設備設計、配置和現有的公共服務工藝方面的知識用于確定CPPs和定義CQAs。例子見下表10.1.Table 10.1 CPP and CQA Considerations that have Potential Risk Impact to a Cleaning Process表10.1 對清潔程序有潛在風險影響的CPP和CQA

Critical process parameters關鍵工藝參數	Criticai Quality Attributes關鍵質量屬性
工藝溫度工藝壓力工藝流程工藝時間清潔劑濃度臟東西保持時間(贓物情況)清潔保持情況	目測或限度清潔劑殘留產品殘留微生物殘留限度濾水性/干燥電導率/電阻率

QRM involves elements of risk assessment, risk control and periodic review to ensure continuous andagement process is best supported by a team of Subject Matter?Experts that have an appropriate level of experience from various areas such as operations, technical?services, engineering, quality control, quality assurance and regulatory. The experience and diversity of?the team provides the opportunityto identify and address all conditions that impact CPP and CQA for the?cleaning or manufacturing process.

QRM涉及風險評估、風險控制和定期審核，從而保證連續和有效的控制。質量風險管理流程最好由來自各個領域的，如生產、技術、工程、質量控制、質量保證和藥政，有一定經驗的主題專家組來構建。專家組成員的經驗和多元化有助于鑒定和說明清潔或生產過程中影響CPP和CQA的所有情況。10.2Techniques and Tools for Risk Management and Assessment10.2 風險管理和評估的方法及工具Techniques and tools for risk management include process mapping, brainstorming, Hazard Analysis and?HACCP, FTA, Cause and Effect Analysis, HAZOP, and FMEA. Risk assessment is initiated early in the life?cycle process starting in the planning, development and specification phases of the cleaning process. Risk?evaluations are performed periodically. Feedback data is used to make decisions that impact the cleaning?process.風險管理的方法和工具包括過程分析、集體討論、危害分析、HACCP(危害分析和關鍵環節控制點)、FTA(故障樹分析)、因果分析、HAZOP(危險與可操作性分析)和FMEA(失效模式影響分析)。風險評估開始于清潔程序整個生命周期的初期階段，從清潔程序的計劃、發展和標準建立階段開始。反饋數據用于對受影響的清潔程序做出決定。Risk analysis is integral to the change management process. The impact of a proposed change is?evaluated for quality and safety impacts, and the outcome of the assessment is used to drive the?activities that are required to effectively implement the change. Low-risk change tasks (such as an?increase in rinsing time) may require little to no additional testing. High-risk change tasks (such as a?change in the nature of the cleaning solution) may require a significant level of testing. Risk analysis can?also be used to determine the economic impact of a change. It may become evident that a proposed?change offers no economic benefit; consequently the change is not implemented.風險分析是變更控制不可或缺的一部分。變更要評估對質量和安全的影響，評估結果有助于變更的有效執行。低風險變更(如延長清洗時間)可能不需要額外檢測。高風險變更(如清洗方法本質改變)可能需要相應程度的檢測。風險分析也能用于確定變更對經濟方面的影響。一個變更有可能很明顯不會帶來經濟效益，因此不會執行該變更。In summary, quality risk management is a systematic process that involves elements of assessments,?development of controls and continuous review throughout the life cycle of the cleaning process. The?risk assessment process is effective at identifying CPPs and CQAs. Risk management tools are used to?generate data and drive decisions. This information is used to affect risk mitigation, and it reduces risk to?an acceptable level. Risk assessments should be documented so that critical factors are identified,?decision pathways are understood, and the information is effectively? communicated to the stakeholders.總而言之，質量風險管理是一個系統的流程，涉及清潔程序整個生命周期的評估、控制開發和連續審核。風險評估能有限鑒別CPPs和CQAs。風險管理工具用于生成數據和做出決策。這些信息會影響風險緩解，降低風險的可接受水平。應當記錄風險評估，以便識別關鍵因素、了解決策思路和使信息有效的傳達給利益相關者。總而言之，質量風險管理是一個系統的流程，涉及清潔程序整個生命周期的評估、控制開發和連續審核。風險評估能有限鑒別CPPs和CQAs。風險管理工具用于生成數據和做出決策。這些信息會影響風險緩解，降低風險的可接受水平。應當記錄風險評估，以便識別關鍵因素、了解決策思路和使信息有效的傳達給利益相關者。免責聲明：上述內容僅供交流學習使用，對文中陳述、觀點判斷保持中立，不對所包含內容的準確性、可靠性或完整性提供任何明示或暗示的保證。僅作參考，并請各位自行承擔全部責任。版權歸原作者所有，如遇版權問題請聯系小編刪除。

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