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Slide 1 - Summary and Next Steps Moheb M. Nasr, Ph.D. Office of New Drug Quality Assessment (ONDQA), OPS, CDER Advisory Committee of Pharmaceutical Science (ACPS) October 25, 2005
Slide 2 - Summary and Next Steps Summary Implementation Strategy Questions to the advisory committee
Slide 3 - Summary Rate of drug release from solid oral dosage forms is a critical quality attribute Desired release characteristics should be designed into DP to meet the performance objectives in the intended patient population - Design specifications Ideally, design specifications should be proposed and established early in drug development to assure the conformance of the pivotal clinical trial product
Slide 4 - Summary In a QbD paradigm, relevant design information must be included in CMC submissions Critical steps and in-process controls identified and justified to demonstrate product knowledge and process understanding Process understanding links manufacturing controls to CQAs/specifications and hence to the desired performance of the DP CQAs are defined through multi-disciplinary interactions, e.g., clinical, pharm/tox The controls of critical variables such as drug particle size may be more relevant in assuring quality, for some drug products, than a dissolution test ICH Q8 will facilitate the implementation of QbD and enhance utility of many aspects of ICH Q6A
Slide 5 - Summary Measurement System: Benefits of Mechanical Calibration and Gauge R&R Sources of variability in the dissolution measurement system can be identified and minimized If needed, an internal calibrator can be developed from the clinical or bio- batch Sources of variability in the dissolution measurement system can be identified and minimized/eliminated Knowledge of variability in measurement system will assure development of meaningful specifications Proposed approach provides a higher assurance of quality than the current system
Slide 6 - Implementation strategy Transfer of dissolution specification setting function to ONDQA Consultation with clinical divisions and OCPB to ensure clinical relevance Initially small cadre of review staff dedicated to setting dissolution specification Parallel training of rest of ONDQA review staff for setting dissolution specification
Slide 7 - Questions to the Advisory Committee Are there relevant scientific areas of disagreement among the stakeholders that would impact moving forward with QbD approach? Should FDA develop a new guidance on a QbD approach to the setting of dissolution specifications? If so, what critical elements should be included in the proposed guidance to distinguish it from the current regulatory approach to setting dissolution specification? What additional considerations are necessary to leverage these efforts further to make this proposed approach a model for setting specifications of other critical quality attributes? Does the Committee agree with the development of a Compliance Policy Guide for use in compliance enforcement activities?