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1、 ICH,November 2010OutlineWorkshop Goals and ObjectivesICH Q8,Q9&Q10How the guidelines are working together throughout the product life cycleUtility of ICH Q8,Q9&Q10Key messagesConclusion第2页/共23页 ICH,November 2010Workshop Goals and ObjectivesThis presentation is intended to outline the linkage betwee
2、n Q 8,9&10 and how the guidelines are working 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 Q10Allow participants to share implementation strategies and expe
3、riences Seek participants input and identify implementation issue and concerns第3页/共23页 ICH,November 2010Nov 2005&Nov 2008November 2005June 2008ICH Q8,Q9 and Q10High level guidances(not prescriptive)Science and risk-basedEncourages systematic approachesApplicable over entire product lifecycleIntended
4、 to work together to enhance pharmaceutical product quality第4页/共23页 ICH,November 2010Pharmaceutical Development-Q8(R2)Describes science and risk-based approaches for pharmaceutical product and manufacturing process developmentIntroduced concepts of design space and flexible regulatory approachesIntr
5、oduced concepts of Quality by Design(QbD)and provided examples of QbD development approaches and design space第5页/共23页 ICH,November 2010Q8(R2)-Example QbD ApproachQuality Target Product Profile(QTPP)Determine“potential”critical quality attributes(CQAs)Link raw material attributes and process paramete
6、rs to CQAs and perform risk assessmentDevelop a design space(optional and not required)Design and implement a control strategyManage product lifecycle,including continual improvement第6页/共23页 ICH,November 2010 Quality Risk Management Q9Describes systematic processes for the assessment,control,communi
7、cation 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 knowledgeLink to the protection of the patient Ex
8、tend over the lifecycle of the product第7页/共23页 ICH,November 2010Quality Risk Management Process-Q9ProcessDevelopmentControl StrategyDevelopmentContinual Improvement of the product第8页/共23页 ICH,November 2010Pharmaceutical Quality System-Q10Describes key systems that facilitate establishment and mainte
9、nance 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 with a robust PQS(Q10)provide opportunities for flexible regulatory app
10、roaches.Relevant PQS elements include systems for:Track and trend product qualityMaintain and update models as neededInternally verify that process changes are successful第9页/共23页 ICH,November 2010Pharmaceutical Quality System-Q10第10页/共23页 ICH,November 2010ICH Q8,Q9 and Q10 Working TogetherFormulatio
11、n Activities:QTPP Definition Pre-Formulation Studies Formulation Screening Optimization&SelectionProcess Development Activities:Process Screening Lab Scale Development Scale-Up StudiesManufacturing Activities:Commercial Scale Manufacturing Batch Release Continual Verification&ImprovementQ8Pharmaceut
12、ical DevelopmentQ9Quality Risk ManagementQ10Pharmaceutical Quality Systems第11页/共23页 ICH,November 2010How 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 no
13、te that they are NOT intended to show complete activities at each stage NOR to show the exact timing(stage)for those activities第12页/共23页 ICH,November 2010Formulation Development ActivitiesICH Q8(R2)PharmaceuticalDevelopment Related ActivitiesICH Q9 QRMRelated ActivitiesICH Q10 PQSRelated Integrated
14、ActivitiesQuality Target Product Profile(QTPP)Clinical and non-clinical studies on drug substance:bioavailability,PK/PD,and safety Informal and/or formal risk assessment to evaluate patient needs and potential medication risks Knowledge Management/Prior Knowledge(relevant information to support the
15、understanding,risk assessment and scope of DOE)-Laboratory note book documentation -Development report -EtcPre-Formulation Studies Characterization of drug substance (physical properties)Chemical stability of drug substance,degradation and potential formulation interactions Development of analytical
16、 tests Determine failure modes and risk factors for drug substance physical and chemical stabilityFormulation Screening Excipient compatibility Dissolution method development Screening DOEs Determine failure modes and risk factors for excipient interactionsFormulation Optimization and Selection Exci
17、pient and drug substance material property&characterization DOEs for excipient amounts Stability of drug product and storage conditions Develop IVIVC relationships Opportunities for formal risk assessment第13页/共23页 ICH,November 2010Process Development ActivitiesICH Q8(R2)Pharmaceutical DevelopmentRel
18、ated 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 for manufactu
19、ring 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 parameters underst
20、anding 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(Pilot Scale)Pi
21、lot 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第14页/共23页 ICH,November 2010Technology TransferICH Q8(R2)Pharmaceutical DevelopmentRelated
22、ActivitiesICH Q9 QRMRelated ActivitiesICH Q10 PQSRelated Integrated Activities Gain product and process knowledge Knowledge supports transfer between development and manufacturing to achieve product realization Forms the basis for the manufacturing process Improves effectiveness of control strategy
23、Contributes to processes validation and ongoing continual improvement Advance understanding through scale-up activities Provide preliminary indication of process performance and successful integration into manufacturing Gain knowledge from transfer and scale up activities to enhance the basis for th
24、e control strategy 第15页/共23页 ICH,November 2010Commercial Manufacturing ActivitiesICH Q8(R2)Pharmaceutical DevelopmentRelated ActivitiesICH Q9 QRMRelated ActivitiesICH Q10 PQSRelated IntegratedActivitiesCommercial Scale Manufacturing for Drug Product Definition of commercial process design Commercial
25、 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,raw material controls and change control Check pro
26、cedures 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.)Documentation to support on-line testing methods Valida
27、tion 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 of process changes and associated effect on inter
28、mediates 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 control procedures including how and when to do
29、risk assessment for process changes and evaluation of the change Maintenance and update of knowledge management第16页/共23页 ICH,November 2010The Utility of ICH Q8,9&10 The implementation of Q8,9&10 is valuable for all drug products,pharmaceutical development approaches and regulatory systemsNew/innovat
30、or,marketed/legacy and generics Simple and complex dosage formsSmall molecule and biotechTraditional development and QbDWithin and outside ICH regionsGood scientific development(Q8)in combination with QRM(Q9)and PQS(Q10)will improve drug quality and efficiency of pharmaceutical manufacturingQuality
31、is important for all drug products throughout product lifecycle(new,legacy and generics)第17页/共23页 ICH,November 2010Key MessagesICH Q8,Q9 and Q10 are linked together to provide a systematic,modern risk-and science-based approach to pharmaceutical manufacturing and developmentComprehensive implementat
32、ion of the three guidelines together is essential to achieve ICH Quality VisionGuidelines are applicable over entire product lifecycleGuidelines can be utilized by all stakeholdersIndustry and regulatorsAssessors and inspectors are expected to incorporate QRM during regulatory processes第18页/共23页 ICH
33、,November 2010Key MessagesTraditional development approaches,as outlined in ICH Q8(R2)part I,are acceptableEnhanced approaches(QbD)provide higher assurance of product quality and additional opportunities for manufacturing efficiency and flexibilityThe use of quality risk management process,methodolo
34、gies and tools(Q9)is beneficial regardless 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第19页/共23页 ICH,November 2010ConclusionsWorkshop m
35、aterials,plenary presentations,and breakout discussions will provide useful information to facilitate pharmaceutical development and manufacturing,and related regulatory aspectsTraining materials provide only illustrative examplesTraining materials are not intended to serve as templates for pharmace
36、utical development,manufacturing,regulatory assessment or inspectionDepending of the pharmaceutical product,other approaches might be appropriate第20页/共23页 ICH,November 2010ConclusionsThe 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第21页/共23页 ICH,November 2010谢谢您的观看！第23页/共23页