Quality Systems and Risk Management Q9 Q10

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Quality Frameworks and Danger Administration (Q9 and Q10). Counseling Panel of the Workplace of Pharmaceutical Science, Community for Medication Assessment and Examination, USFDA October 5, 2006 Frederick Razzaghi CHPA. Plan. Presentation Quality Danger Administration Q9 Connection of Q9 to Q10 The direction

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Quality Systems and Risk Management (Q9 & Q10) Advisory Committee of the Office of Pharmaceutical Science, Center for Drug Evaluation and Research, USFDA October 5, 2006 Frederick Razzaghi CHPA

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Agenda Introduction Quality Risk Management Q9 Relation of Q9 to Q10 The direction Next step

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Establishing the science to help settle questions. (building up the information) Doing what is essential. (Would we be able to stand to do everything?)

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Doing what is essential (Risk based) Non-science and priority based Requirements have an aggregate impact. Overpower associations. Associations can not answer the esteem address! Highlighted to a limited extent by the present time of lessening assets and interest for speedier and better results.

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Risk based Quality Risk Management: Using built up learning to figure out what is vital

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What is Q9 is a systemic procedure situated way to deal with basic leadership that is proposed to be down to earth, relevant, prescient, adaptable, steady and coordinated. The ICH Q9 report: Main body clarifies the " What? " Annex (I) give thoughts on the " How? " Annex (II) give thoughts on the " Where? " It is intended to be actualized by industry and controllers Pharmaceutical advancement (ICH Q8) and Quality Systems (ICH Q10) will encourage the "What?", "How?" and "Where?" " It streamlines and avert excessively prescriptive and superfluous necessities.

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What does Q9 offer Quality hazard administration fills in as an establishment to bolster, other ICH Quality archives and supplement best quality practices, necessities, models, and rules inside industry and controllers. It particularly gives direction on the standards and a portion of the devices of value hazard administration to empower predictable hazard based choices over the item lifecycle.

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Reasons for composing Q9 The conditions influencing controllers & industry Increasing outside prerequisites Increasing requests and costs Growing multifaceted nature and extent of dangers Empowerment & Flexibility Master many-sided quality and streamline basic leadership Proactive divulgence and assemble trust and understanding Improve correspondence through sharing best practice and science based information Convert information into learning

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Reasons for composing Q9 Establish a typical comprehension of Quality Risk Management (QRM) among industry and skillful experts Facilitate moving to the "Coveted State" By upgrading correspondence and straightforwardness Moving from 'putting out fires' to proactive administration of hazard

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Benefits of hazard administration Enhanced open trust in basic leadership on pharmaceutical quality Promotes more compelling utilization of controller and industry assets Establishes deliberate and better-educated basic leadership. Builds learning of hazard Fosters quality by plan and consistent change

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Benefits of hazard administration Understand the elements that effect controllers and industry operations. Make mindfulness and a culture Supports ace dynamic conduct Open authentic exchange Make choices traceable and reliable Provide confirmation Risks are sufficiently overseen Compliance to outside and inside necessities Recognize dangers at a coveted level Zero hazard impractical

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Q9 connects back to patient security . Chances to effect chance utilizing quality hazard administration Design Process Materials Manufacturing Facilities Distribution Patient

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Q9 was built utilizing learning picked up from set up gauges ISO/IEC Guide 73 : 2002 - Risk Management - Vocabulary - Guidelines for use in Standards ISO/IEC Guide 51 :1999 - Safety Aspects - Guideline for their consideration in models WHO Technical Report Series No 908, 2003 Annex 7 Application of Hazard Analysis and Critical Control Point (HACCP) procedure to pharmaceuticals GAMP Good Practice Guide ISPE, 2005 A hazard based way to deal with agreeable electronic records and marks ISO 14971 :2000 - Application of Risk Management to Medical Devices

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Developing the information: (Science based) The Q archives are a piece of the learning. Building up new learning Combining fundamental orders & hones Core: Engineering, Pharmaceutical sciences, Gap: Technology, Economics, Management (chance, … .)

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Q9 coordinated into Q10

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ICH Q reports Q1 Stability Q2 Analytical Validation Q3 Impurities Q4 Pharmacopeias Q5 Quality of Biotechnological Products Q6 Specifications Q7 Good Manufacturing Practice Q8 Pharmaceutical Development Q9 Quality Risk Management Q10 Pharmaceutical Quality Systems

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Q9 empowers quality frameworks to address the accompanying issues Product may not be accessible to patients Increase the potential for arrival of unsuitable item Delay in new item presentations Delays in the usage of changes and upgrades Recall of medications Inefficient distribution of assets

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Q8, Q9 and Q10 are adjusted to the new approach GMP Workshop in July 2003: 5 year vision : " Develop a fit pharmaceutical quality framework appropriate over the life cycle of the item underlining an incorporated way to deal with quality hazard administration and science " Consequent ICH Expert Working Groups (EWG): ICH Q8 , on Pharmaceutical Development , doc. affirmed Nov. 2005 ICH Q9 , on Quality Risk Management , doc. endorsed Nov. 2005 ICH Q10 , on Quality Systems , theme acknowledged 2005

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How Q9 cooperates with Q8 and Q10 imagine Risk from Manufacturing site High Q10 Pharm. Quality Systems Low Q8 Pharmaceutical Development Low High Product/Process Risk

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New Q qualifications Pharmaceutical Development (Q8) Past: Data exchange/Variable yield Present: Knowledge exchange/Science based/Consistent output Quality Risk Management (Q9) Past: Used, however ineffectively characterized Present: Opportunity to utilize organized process and coordinated thinking Pharmaceutical Quality Systems (Q10) Past: GMP agenda Future : Quality Systems crosswise over item life cycle

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New Q refinements

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The Guidance Process Formula Relationship to vulnerability Tools Application & combination

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Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unsatisfactory R i n s o k i t a M Risk Control c an i n a u g Risk Reduction m e m o e C n t k t Risk Acceptance s o i o R l s Output/Result of the Quality Risk Management Process Risk Review Events The procedure

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Dimensions of a hazard based approach . Parameters for assessing dangers high likelihood medium perceptibility okay seriousness

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Risk and Uncertainty . Tomorrow ? Upper Specification Limit (USL) Process Parameter  Lower Specification Limit (LSL) Time  today RISK: Control alternatives are situations for hazard administration. Take note of that this situation demonstrates the best gauge is underneath the USL.

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Risk and vulnerability Components of instability: Limitations of human information Absence of built up science. Constraints of Technology

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Some Risk appraisal devices Failure Mode & Effects Analysis (FMEA) Failure Mode, Effects and Criticality Analysis (FMECA) Fault Tree Analysis (FTA) Hazard Analysis of Critical Control Points (HACCP) Hazard Operability Analysis (HAZOP) Preliminary Hazard Analysis (PHA) Risk positioning and separating

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Application & Integration

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Q9 applies over the lifecycle . Inquire about Preclinical Phase Clinical Phases Launch Manufacturing & Distribution Safety GLP GCP Efficacy GMP Quality ICH Q9 GDP

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Integrating QRM into item life cycle Gain encounter Analyze main driver: Continuous change (Risk of) Failure ? Fabricate Quality Risk Management (QRM) Improve it Do, what you say Update data Approval Say, what you do

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Integration into operations: industry & controllers Foundation for " science-based" choices Degree of thoroughness and custom equivalent with the unpredictability as well as criticality of the issue Implement QRM standards when refreshing existing rules

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Regulatory operations Inspection and appraisal exercises Internal frameworks Industry operations Development Facilities, gear and utilities Materials management Production Laboratory control and security testing Packaging and naming Application

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Application Integrated quality management Documentation Training and instruction Quality deformities Auditing/Inspection Periodic survey Change administration/change control Continual change

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Application Quality hazard administration is expected to empower and upgrade consistence with administrative necessities and science-based choices when coordinated into quality frameworks. It is likewise intended to be connected where it is down to earth and practical.

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Implementation of Q9 can help recognize frail connections

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Definitions Quality : Degree to which an arrangement of natural properties of an item, framework or process satisfies necessities Risk : blend of the likelihood of event of mischief and the seriousness of that damage Quality Risk administration : Systematic process for the appraisal, control, correspondence and survey of dangers to the nature of the medication (therapeutic) item over the item lifecycle

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Way Forward Review Implementation

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Implementation Work to Adapt existing structures, associations and frameworks Raise attention to bases for basic leadership Education: Develop preparing Do not make new prerequisites

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Implementation Work to Improve correspondence and straightforwardness More particular tasks: (e.g. DMF's) Academic joint efforts

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Review and decide holes Examine requirement for addit