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1、【純干貨】PDA TR49 生物制品清潔驗(yàn)證考慮要點(diǎn)(中英文版)節(jié)選1(1.0-2.0)

2、【純干貨】清潔程序的設(shè)計(jì)與開(kāi)發(fā)(中英文版)(PDA TR 49內(nèi)容節(jié)選)

3、【純干貨】清潔驗(yàn)證可接受限度(中英文版)(PDA TR 49內(nèi)容節(jié)選3)

4、【純干貨】清潔驗(yàn)證可接受限度-下(中英文版)(PDA TR 49內(nèi)容節(jié)選4)

5、【純干貨】清潔驗(yàn)證之取樣方法(PDA TR 49內(nèi)容節(jié)選5 中英文版)

6、【純干貨】清潔驗(yàn)證之分析方法-上(PDA TR 49內(nèi)容節(jié)選6 中英文版)

7、【純干貨】清潔驗(yàn)證之分析方法-下(PDA TR 49內(nèi)容節(jié)選7 中英文版)

8、【純干貨】清潔驗(yàn)證方案(PDA TR 49內(nèi)容節(jié)選8?中英文版)9、【純干貨】驗(yàn)證狀態(tài)維護(hù)(PDA TR 49內(nèi)容節(jié)選9 中英文版)10、純干貨】總體規(guī)劃清潔驗(yàn)證(PDA TR 49內(nèi)容節(jié)選10 中英文版)10.0 Risk assessment and Management風(fēng)險(xiǎn)評(píng)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(zhì)量風(fēng)險(xiǎn)管理(QRM)是一個(gè)便于應(yīng)用且合理的流程，它能有效地支持計(jì)劃和策略，使系統(tǒng)或工藝維持在連續(xù)的質(zhì)量監(jiān)督下。質(zhì)量風(fēng)險(xiǎn)管理有許多優(yōu)點(diǎn)，但不局限于以下幾點(diǎn)：改進(jìn)計(jì)劃、預(yù)防潛在失誤

• ??增進(jìn)對(duì)系統(tǒng)、工藝和產(chǎn)品關(guān)鍵方面的理解

• ? 通過(guò)更好的溝通改善利益雙方關(guān)系

• ? 通過(guò)對(duì)決策流程的記錄提高保障水平

• ? 通過(guò)改進(jìn)工藝消除或減少風(fēng)險(xiǎn)，降低給患者帶來(lái)的風(fēng)險(xiǎn)

• ? 提高故障檢測(cè)性

• ? 優(yōu)化驗(yàn)證資源

• ? 選擇檢測(cè)方法和可接受標(biāo)準(zhǔn)，同產(chǎn)品關(guān)鍵質(zhì)量屬性一致

• ? 符合法規(guī)要求或期望

• ? 使工藝維持在受控狀態(tài)

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(fēng)險(xiǎn)管理貫穿于生產(chǎn)系統(tǒng)整個(gè)設(shè)計(jì)和驗(yàn)證策略。風(fēng)險(xiǎn)管理是一個(gè)連續(xù)的過(guò)程。分析和評(píng)估關(guān)鍵的投料量和數(shù)據(jù)，采取風(fēng)險(xiǎn)緩解措施確保設(shè)計(jì)合理有效，證明目標(biāo)系統(tǒng)符合預(yù)期用途。清潔和清潔驗(yàn)證要求由工藝系統(tǒng)、臟物和設(shè)備清潔相關(guān)(如化學(xué)和機(jī)械特性)的知識(shí)來(lái)確定。這些要求要通過(guò)設(shè)計(jì)審核，然后證實(shí)符合可接受標(biāo)準(zhǔn)，該可接受標(biāo)準(zhǔn)用于證明系統(tǒng)要求已經(jīng)達(dá)根據(jù)產(chǎn)品知識(shí)、工藝知識(shí)、法規(guī)和質(zhì)量屬性確定清潔要求，規(guī)定能夠最好支持清潔生產(chǎn)系統(tǒng)和組分的方法。可能影響清潔的問(wèn)題包括：臟物類(lèi)型、清潔程序、設(shè)備設(shè)計(jì)、配置和現(xiàn)有的公共服務(wù)工藝方面的知識(shí)用于確定CPPs和定義CQAs。例子見(jiàn)下表10.1.Table 10.1 CPP and CQA Considerations that have Potential Risk Impact to a Cleaning Process表10.1 對(duì)清潔程序有潛在風(fēng)險(xiǎn)影響的CPP和CQA

Critical process parameters關(guān)鍵工藝參數(shù)	Criticai Quality Attributes關(guān)鍵質(zhì)量屬性
工藝溫度工藝壓力工藝流程工藝時(shí)間清潔劑濃度臟東西保持時(shí)間(贓物情況)清潔保持情況	目測(cè)或限度清潔劑殘留產(chǎn)品殘留微生物殘留限度濾水性/干燥電導(dǎo)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(fēng)險(xiǎn)評(píng)估、風(fēng)險(xiǎn)控制和定期審核，從而保證連續(xù)和有效的控制。質(zhì)量風(fēng)險(xiǎn)管理流程最好由來(lái)自各個(gè)領(lǐng)域的，如生產(chǎn)、技術(shù)、工程、質(zhì)量控制、質(zhì)量保證和藥政，有一定經(jīng)驗(yàn)的主題專(zhuān)家組來(lái)構(gòu)建。專(zhuān)家組成員的經(jīng)驗(yàn)和多元化有助于鑒定和說(shuō)明清潔或生產(chǎn)過(guò)程中影響CPP和CQA的所有情況。10.2Techniques and Tools for Risk Management and Assessment10.2 風(fēng)險(xiǎn)管理和評(píng)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(fēng)險(xiǎn)管理的方法和工具包括過(guò)程分析、集體討論、危害分析、HACCP(危害分析和關(guān)鍵環(huán)節(jié)控制點(diǎn))、FTA(故障樹(shù)分析)、因果分析、HAZOP(危險(xiǎn)與可操作性分析)和FMEA(失效模式影響分析)。風(fēng)險(xiǎn)評(píng)估開(kāi)始于清潔程序整個(gè)生命周期的初期階段，從清潔程序的計(jì)劃、發(fā)展和標(biāo)準(zhǔn)建立階段開(kāi)始。反饋數(shù)據(jù)用于對(duì)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(fēng)險(xiǎn)分析是變更控制不可或缺的一部分。變更要評(píng)估對(duì)質(zhì)量和安全的影響，評(píng)估結(jié)果有助于變更的有效執(zhí)行。低風(fēng)險(xiǎn)變更(如延長(zhǎng)清洗時(shí)間)可能不需要額外檢測(cè)。高風(fēng)險(xiǎn)變更(如清洗方法本質(zhì)改變)可能需要相應(yīng)程度的檢測(cè)。風(fēng)險(xiǎn)分析也能用于確定變更對(duì)經(jīng)濟(jì)方面的影響。一個(gè)變更有可能很明顯不會(huì)帶來(lái)經(jīng)濟(jì)效益，因此不會(huì)執(zhí)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(zhì)量風(fēng)險(xiǎn)管理是一個(gè)系統(tǒng)的流程，涉及清潔程序整個(gè)生命周期的評(píng)估、控制開(kāi)發(fā)和連續(xù)審核。風(fēng)險(xiǎn)評(píng)估能有限鑒別CPPs和CQAs。風(fēng)險(xiǎn)管理工具用于生成數(shù)據(jù)和做出決策。這些信息會(huì)影響風(fēng)險(xiǎn)緩解，降低風(fēng)險(xiǎn)的可接受水平。應(yīng)當(dāng)記錄風(fēng)險(xiǎn)評(píng)估，以便識(shí)別關(guān)鍵因素、了解決策思路和使信息有效的傳達(dá)給利益相關(guān)者?？偠灾?#xff0c;質(zhì)量風(fēng)險(xiǎn)管理是一個(gè)系統(tǒng)的流程，涉及清潔程序整個(gè)生命周期的評(píng)估、控制開(kāi)發(fā)和連續(xù)審核。風(fēng)險(xiǎn)評(píng)估能有限鑒別CPPs和CQAs。風(fēng)險(xiǎn)管理工具用于生成數(shù)據(jù)和做出決策。這些信息會(huì)影響風(fēng)險(xiǎn)緩解，降低風(fēng)險(xiǎn)的可接受水平。應(yīng)當(dāng)記錄風(fēng)險(xiǎn)評(píng)估，以便識(shí)別關(guān)鍵因素、了解決策思路和使信息有效的傳達(dá)給利益相關(guān)者。免責(zé)聲明：上述內(nèi)容僅供交流學(xué)習(xí)使用，對(duì)文中陳述、觀點(diǎn)判斷保持中立，不對(duì)所包含內(nèi)容的準(zhǔn)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(qǐng)各位自行承擔(dān)全部責(zé)任。版權(quán)歸原作者所有，如遇版權(quán)問(wèn)題請(qǐng)聯(lián)系小編刪除。

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【高峰論壇】第一屆無(wú)菌產(chǎn)品污染控制策略(CCS)高峰論壇(2020/11-26-28 上海)【線(xiàn)下專(zhuān)題小班】(11月北京)符合2020年版藥典分析方法驗(yàn)證、確認(rèn)、轉(zhuǎn)移風(fēng)險(xiǎn)評(píng)估的有效實(shí)施和案例分析【線(xiàn)下專(zhuān)題小班】(11月長(zhǎng)春)基于ISPE\WHO最新指南的制藥用水系統(tǒng)和空調(diào)系統(tǒng)驗(yàn)證【線(xiàn)下專(zhuān)題小班】(11月廣州)2020“1法2辦法”下的制藥企業(yè)年度質(zhì)量回顧及數(shù)據(jù)統(tǒng)計(jì)、分析和報(bào)告【線(xiàn)下專(zhuān)題小班】(11月北京)2020“1法2辦法”下的制藥企業(yè)年度質(zhì)量回顧及數(shù)據(jù)統(tǒng)計(jì)、分析和報(bào)告【線(xiàn)下專(zhuān)題小班】(11月蘇州)新政下藥品注冊(cè)核查的新要求及工藝變更申報(bào)、實(shí)施要點(diǎn)

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