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1、International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human UseImplementation of ICH Q8,Q9,Q10How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle ICH Quality Implementation Working Group-Integrated Implementation Tr
2、aining Workshop slide 3How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle OutlineWorkshop Goals and ObjectivesICH Q8,Q9&Q10How the guidelines are working together throughout the product life cycleUtility of ICH Q8,Q9&Q10Key messagesConclusion ICH,November 2010ICH Qua
3、lity Implementation Working Group-Integrated Implementation Training Workshop slide 4How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Workshop Goals and ObjectivesThis presentation is intended to outline the linkage between Q 8,9&10 and how the guidelines are worki
4、ng togetherThis presentation is NOT intended to outline regulatory expectations(assessment and/or inspection)This workshop will:-Provide training on the integrated implementation of Q 8,Q9 and Q10-Allow participants to share implementation strategies and experiences-Seek participants input and ident
5、ify implementation issue and concerns ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 5How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Nov 2005&Nov 2008November 2005June 2008ICH Q8,Q9 and Q10High level gu
6、idances(not prescriptive)Science and risk-basedEncourages systematic approachesApplicable over entire product lifecycleIntended to work together to enhance pharmaceutical product quality ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 6How
7、ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Pharmaceutical Development-Q8(R2)Describes science and risk-based approaches for pharmaceutical product and manufacturing process developmentIntroduced concepts of design space and flexible regulatory approachesIntroduce
8、d concepts of Quality by Design(QbD)and provided examples of QbD development approaches and design space ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 7How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Q8
9、(R2)-Example QbD ApproachQuality Target Product Profile(QTPP)Determine“potential”critical quality attributes(CQAs)Link raw material attributes and process parameters to CQAs and perform risk assessmentDevelop a design space(optional and not required)Design and implement a control strategyManage prod
10、uct lifecycle,including continual improvement ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 8How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Quality Risk Management Q9Describes systematic processes for
11、the assessment,control,communication and review of quality risks Applies over product lifecycle:development,manufacturing and distributionIncludes principles,methodologies and examples of tools for quality risk managementAssessment of risk to quality should:-Be based on scientific knowledge-Link to
12、the protection of the patient-Extend over the lifecycle of the product ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 9How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Quality Risk Management Process-Q9Pr
13、ocessDevelopmentControl StrategyDevelopmentContinual Improvement of the product ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 10How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Pharmaceutical Quality Sys
14、tem-Q10Describes key systems that facilitate establishment and maintenance of a state of control for process performance and product qualityFacilitates continual improvementApplies to drug substance and drug product throughout product lifecycleSound pharmaceutical development(Q8R(2)in combination wi
15、th a robust PQS(Q10)provide opportunities for flexible regulatory approaches.Relevant PQS elements include systems for:-Track and trend product quality-Maintain and update models as needed-Internally verify that process changes are successful ICH,November 2010ICH Quality Implementation Working Group
16、-Integrated Implementation Training Workshop slide 11How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Pharmaceutical Quality System-Q10 ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 12How ICH Q8,Q9,Q10 g
17、uidelines are working together throughout the product life cycle ICH Q8,Q9 and Q10 Working TogetherFormulation Activities:QTPP Definition Pre-Formulation Studies Formulation Screening Optimization&SelectionProcess Development Activities:Process Screening Lab Scale Development Scale-Up StudiesManufac
18、turing Activities:Commercial Scale Manufacturing Batch Release Continual Verification&ImprovementQ8Pharmaceutical DevelopmentQ9Quality Risk ManagementQ10Pharmaceutical Quality Systems ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 13How IC
19、H Q8,Q9,Q10 guidelines are working together throughout the product life cycle How can the three guidelines work togetherThe following four slides(slides 14-17)are intended to show how Q8,Q9,Q10 can work together at different stages of the product lifecycleIt is important to note that they are NOT in
20、tended to show complete activities at each stage NOR to show the exact timing(stage)for those activities ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 14How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle F
21、ormulation Development ActivitiesICH Q8(R2)PharmaceuticalDevelopment Related ActivitiesICH Q9 QRMRelated ActivitiesICH Q10 PQSRelated Integrated ActivitiesQuality Target Product Profile(QTPP)Clinical and non-clinical studies on drug substance:bioavailability,PK/PD,and safety Informal and/or formal r
22、isk assessment to evaluate patient needs and potential medication risks Knowledge Management/Prior Knowledge(relevant information to support the understanding,risk assessment and scope of DOE)-Laboratory note book documentation -Development report -EtcPre-Formulation Studies Characterization of drug
23、 substance (physical properties)Chemical stability of drug substance,degradation and potential formulation interactions Development of analytical tests Determine failure modes and risk factors for drug substance physical and chemical stabilityFormulation Screening Excipient compatibility Dissolution
24、 method development Screening DOEs Determine failure modes and risk factors for excipient interactionsFormulation Optimization and Selection Excipient and drug substance material property&characterization DOEs for excipient amounts Stability of drug product and storage conditions Develop IVIVC relat
25、ionships Opportunities for formal risk assessment ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 15How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Process Development ActivitiesICH Q8(R2)Pharmaceutical D
26、evelopmentRelated ActivitiesICH Q9 QRM Related ActivitiesICH Q10 PQSRelated Integrated ActivitiesProcess Screening Exploration of unit operations Characterization of process intermediates Determine failure modes,risk factors for unit operations and rank risk Batch records and operational guidelines
27、for manufacturing Tech Transfer report Identification and selection of suppliers that meet raw material needsProcess Development and Optimization(Lab Scale)DOEs for process parameters and interactions with material attributes Development of Design Space Operational ranges for scale-independent param
28、eters understanding of critical process operations Screening risk assessment to determine potential parameters impacting product quality(e.g.,Ishikawa)Determine critical process steps,process parameters and material attributes(e.g.,FMEA)Potential issues of scaleProcess Development and Optimization(P
29、ilot Scale)Pilot to verify lab scale knowledge DOE and modeling effects of scale Development of design space Development of on-line measurement technologies Development of control strategy to control risks incl.for scale up ICH,November 2010ICH Quality Implementation Working Group-Integrated Impleme
30、ntation Training Workshop slide 16How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Technology TransferICH Q8(R2)Pharmaceutical DevelopmentRelated ActivitiesICH Q9 QRMRelated ActivitiesICH Q10 PQSRelated Integrated Activities Gain product and process knowledge Knowl
31、edge supports transfer between development and manufacturing to achieve product realization Forms the basis for the manufacturing process Improves effectiveness of control strategy Contributes to processes validation and ongoing continual improvement Advance understanding through scale-up activities
32、 Provide preliminary indication of process performance and successful integration into manufacturing Gain knowledge from transfer and scale up activities to enhance the basis for the control strategy ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Worksho
33、p slide 17How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Commercial Manufacturing ActivitiesICH Q8(R2)Pharmaceutical DevelopmentRelated ActivitiesICH Q9 QRMRelated ActivitiesICH Q10 PQSRelated IntegratedActivitiesCommercial Scale Manufacturing for Drug Product De
34、finition of commercial process design Commercial scale runs to verify process design,with additional sampling to verify understanding Implementation of on-line measurement technologies Development of a control strategy for commercial manufacturing,including in-process controls,end-product testing,ra
35、w material controls and change control Check procedures in the PQS regarding risk from Process specific procedure(e.g.,sampling plans,design space and model verification,change control for movement within design space)Process-specific operating procedures(e.g.sampling plans,design space etc.)Documen
36、tation to support on-line testing methods Validation to demonstrate process and analytical method reproducibility Storage of development reports,risk assessmentsContinual Process Verification and Continual Improvement On-going analysis and trending of process data,(multivariate SPC,etc.)Evaluation o
37、f process changes and associated effect on intermediates and products Manage risks of process or material attribute change (including changes within or outside of design space)Review risks in audits/inspections and implement risk-based CAPAs Procedures on process monitoring and action limits Change
38、control procedures including how and when to do risk assessment for process changes and evaluation of the change Maintenance and update of knowledge management ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 18How ICH Q8,Q9,Q10 guidelines a
39、re working together throughout the product life cycle The Utility of ICH Q8,9&10 The implementation of Q8,9&10 is valuable for all drug products,pharmaceutical development approaches and regulatory systems-New/innovator,marketed/legacy and generics -Simple and complex dosage forms-Small molecule and
40、 biotech-Traditional development and QbD-Within and outside ICH regionsGood scientific development(Q8)in combination with QRM(Q9)and PQS(Q10)will improve drug quality and efficiency of pharmaceutical manufacturing-Quality is important for all drug products throughout product lifecycle(new,legacy and
41、 generics)ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 19How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Key MessagesICH Q8,Q9 and Q10 are linked together to provide a systematic,modern risk-and scienc
42、e-based approach to pharmaceutical manufacturing and developmentComprehensive implementation of the three guidelines together is essential to achieve ICH Quality Vision-Guidelines are applicable over entire product lifecycleGuidelines can be utilized by all stakeholders-Industry and regulators-Asses
43、sors and inspectors are expected to incorporate QRM during regulatory processes ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Training Workshop slide 20How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle Key MessagesTraditional de
44、velopment approaches,as outlined in ICH Q8(R2)part I,are acceptable-Enhanced approaches(QbD)provide higher assurance of product quality and additional opportunities for manufacturing efficiency and flexibilityThe use of quality risk management process,methodologies and tools(Q9)is beneficial regardl
45、ess of development or manufacturing approaches used Pharmaceutical Quality Systems(Q10)applies to drug substance and drug product throughout product lifecycle and provide tools to facilitates continual improvement ICH,November 2010ICH Quality Implementation Working Group-Integrated Implementation Tr
46、aining Workshop slide 21How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle ConclusionsWorkshop materials,plenary presentations,and breakout discussions will provide useful information to facilitate pharmaceutical development and manufacturing,and related regulatory a
47、spects-Training materials provide only illustrative examples-Training materials are not intended to serve as templates for pharmaceutical development,manufacturing,regulatory assessment or inspection-Depending of the pharmaceutical product,other approaches might be appropriate ICH,November 2010ICH Q
48、uality Implementation Working Group-Integrated Implementation Training Workshop slide 22How ICH Q8,Q9,Q10 guidelines are working together throughout the product life cycle ConclusionsThe main goal of this workshop is to provide training on the comprehensive implementation of Q8,Q9 and Q10Workshop feedback will be utilized by IWG to further improve the implementation for the new paradigm of pharmaceutical quality ICH,November 2010