Administrative Aspects of Product Development ICH Process Q8, Q9, Q10 WHO Workshop, October 2007

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Center of Presentation. ICH ProcessICH Q8, Q9, Q10Pharmaceutical Development. ICH. BACKGROUNDICH set up in 1990 as joint industry/administrative venture to enhance through harmonization the effectiveness of the procedure for creating and enrolling new restorative productsThe Fourth International Conference on Harmonization (ICH 4), Brussels, 1997 imprints the fruition of the first phaseIt was concurred

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´╗┐Administrative Aspects of Product Development ICH Process Q8, Q9, Q10 WHO Workshop, October 2007 Sultan Ghani, Director Bureau of Pharmaceutical Sciences Therapeutic Products Directorate, Health Canada

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Focus of Presentation ICH Process ICH Q8, Q9, Q10 Pharmaceutical Development

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ICH BACKGROUND ICH set up in 1990 as joint industry/administrative venture to enhance through harmonization the effectiveness of the procedure for creating and enlisting new restorative items The Fourth International Conference on Harmonization (ICH 4), Brussels, 1997 imprints the culmination of the principal stage It was concurred that the second period of harmonization keep on ensuring the future exercises of ICH

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ICH FUTURE OF ICH A Continuation of Harmonization Activity/Mechanism to blend new specialized prerequisites Process for upgrading and supplementing the current ICH Guidelines Prevent future disharmony through early coordinated effort and trade of data

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ICH STRUCTURE Founding Members: Europe European Commission (EC) European Federation of Pharmaceutical Industries Associations (EFPIA) Japan Ministry of Health and Welfare (MHW) Japan Pharmaceutical Manufacturers Association (JPMA) U.S.A. U.S. Nourishment and Drug Administration (FDA) Pharmaceutical Research and Manufacturers of America (PhRMA )

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ICH STRUCTURE (cont'd) Other Members : Observers World Health Organization (WHO) Therapeutic Products Program (TPP) European Free Trade Association (EFTA) Extended Working Group Members Pharmacopoeial Authorities Generic Industry Association Non-Prescription Pharmaceutical Industry Secretariat The International Federal of Pharmaceutical Manufacturers Association (IFPMA)

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The Five Steps in the ICH Process for Harmonization of Technical Issues

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New Era With New Challenges Q8 Q9 Q10 " chance based " ideas and standards of ICH Ref: ICH

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Pharmaceutical Development Paths Q8 is not yet finished by ICH Design Space For Continuous Improvement

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ICH's Vision of the Future Adapted from EFPIA, PAT Topic Group, 2005

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QbD-a Well Known Concept of the 50's Ref: Out of Crisis (1986): W. Edwards Deming Depending on examination resembles treating an indication while the sickness is murdering you. The requirement for examination comes about because of inordinate fluctuation all the while. The ailment is the changeability. Stopping reliance on examination implies you should comprehend your procedures so well that you can foresee the nature of their yield from upstream exercises and estimations. To fulfill this you should have a careful comprehension of the wellsprings of variety in your procedures and after that work toward diminishing the variety . Stopping reliance on examination constrains you to lessen inconstancy . Ref:

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Traditional PD v ersus QbD Traditional Product Development: Limited advancement and scale-up work Final affirmation by approval of 3 bunches 'Assuming the worst possible scenario' situations expected to be incorporated Market reviews and underutilization of limit show this approach has had restricted achievement . QbD: Complete comprehension of process and observing of every single basic stride. Restorative moves are made to avert item disappointment. Adequate nature of the item is guaranteed: No reviews Innovation supported Maximize usage of limit

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Quality by Design Traditional Process Validation Establish archived confirm which will give a high level of affirmation that a particular procedure will reliably deliver an item meeting its foreordained detail"

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Quality by Design Traditional Process Validation (cont'd) Process Validation Protocol Three parcels Extensive and regular inspecting More than routine testing Proven homogeneity inside a great deal Consistent item quality between three parcels

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Quality by Design Traditional Process Validation (cont'd) Well recorded Protocol and Report Well arranged demo that item can be created three circumstances Resolution of all deviation Investigation report with defense Review and endorsement

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Quality by Design Traditional Product Development . . Complex multivariate physiochemical framework Treated as uni-variate framework (one element at any given moment) Materials not all around portrayed Process components not surely knew Time crunch Reluctant for post endorsement changes

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Quality by Design Traditional Establishment of Product Specification Compendial (for the most part) Critical process parameter Can be identified with item security and adequacy according to clinical trials Based on process capacity Literature Experience

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Design Space

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Quality by Design

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Quality by Design Definition Design of Experiment (DOE) "Robotic comprehension of how plan and process variables influence item execution and quality".

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Quality by Design Definition Process Analytical Technology (PAT) "An arrangement of outlining, breaking down and controlling assembling through opportune estimations (amid handling) of basic quality traits of in-process materials and procedures with the target of guaranteeing finished result quality in each parcel".

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Quality by Design Definition Risk Management "Methodical process for the distinguishing proof, evaluation and control of hazard to the nature of pharmaceutical over the item lifecycle" FMEA "An organized procedure for recognizing the way an item or process can come up short"

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Quality by Design Definition Critical Quality Attributes (CQA) "Property of a material, item or yield of a procedure that is vital to the procedure execution" Critical Process Parameters (CPP) "A procedure parameter, e.g. temp, time, speed, when variable it can influence the CQA of an item or process" Cause and Effect Analysis (C&E) "An investigational apparatus to discover and measure the circumstances and end results relationship for a procedure or item disappointment"

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Quality by Design Good DOE requires Scientific comprehension of how plan and process components impact item execution Understanding and ID of CPP and their consequences for CQA Experiment in light of the standards of insights Identifying and concentrate the impact and collaboration of item and process factors Use of the multivariate information investigation

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Quality by Design Risk Assessment Process of hazard appraisal to alleviate dangers Identify the underlying drivers of process disappointment Help keep issues from happening Quantitative prioritization of potential disappointment Improve quality and unwavering quality of item Documented verification of move made to lessen and kill dangers Key contributions of hazard evaluation

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Quality by Design Traditional Online Control (QA Inspection) Statistical and handle controls connected at assembling stage (diligent work after the examination) Future Offline Control (quality by outline) Statistics and process building application at configuration period of the item

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Quality by Design Establishment of Product Specification Provide affirmation to keep up item quality Specification to affirm the quality versus portrayal Linked to assembling process Account for the strength Linked to preclinical and clinical reviews Linked to expository systems

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Quality by Design The result Provision of more noteworthy comprehension of pharmaceutical and assembling sciences makes a reason for adaptable administrative approach Establishing an important item particular (Q6) and the hazard based approach (Q9) can make adaptability for the constant change (e.g. post-endorsement changes) without the requirement for earlier endorsement supplement Industry can help the CMC analyst and GMP examiners by giving the discretionary data in CTD

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Quality by Design The result (cont'd) Gives Industry the open door by means of an orchestrated standard to understand the maximum capacity of Q8 and to use Q9 Encourages and persuades Industry to enhance and enhance forms, gear, offices, frameworks and techniques Gives Regulators the certainty that Industry can be in charge of more noteworthy self-administration of upgrades and changes Companies with great quality administration frameworks Well controlled procedures and items

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Future Vision Is Driven by ICH Q9 Manage hazard to tolerant, in view of science : Product, process and office Robustness of Quality System Relevant controls to survey & alleviate chance Level of oversight required proportionate with the level of hazard to quiet to market: approval applications Post-endorsement change audit GMP investigations Ref: ICH

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Quality Risk Management Quality: Degree to which an arrangement of natural properties of an item, framework or process satisfies prerequisites. Hazard: characterized as the mix of the likelihood of event of mischief and the seriousness of that damage. Administration: Systematic process for the appraisal , control , correspondence and audit of dangers to the nature of the medication (restorative) item over the item lifecycle .

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Pharmaceutical Development To plan a quality item and its assembling procedure to convey the planned execution of the item To give logical comprehension to bolster the foundation of outline, determinations and assembling Product improvement thinks about shape a premise of value hazard administration

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Pharmaceutical Development Quality can't be tried in the item; it ought to be inherent by configuration Design space proposed by candidate is liable to administrative appraisal and working inside the space is not a change Movement out of configuration space is thought to be a change and requires post-endorsement change handle

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Pharmaceutical Development Critical part of