工人年度考核表Title.pptVIP

Regulatory Assessment Disclaimer The information within this presentation is based on the ICH Q-IWG members expertise and experience, and represents the views of the ICH Q-IWG members for the purposes of a training workshop. Presentation Overview Goal of Regulatory Quality Assessment Review of the case study Considerations during regulatory evaluation Areas of consideration by assessors will be presented in the form of questions for the assessor The questions presented here are not necessarily the ones which are finally communicated in regulatory deficiency letters API and Formulation Manufacturing Process Development Quality Risk Management Design Space Proposed Control Strategyand Real Time Release Testing Assessors - Inspector Interaction Goal of Regulatory Quality Assessment Assess That the product is capable of consistently meeting the required quality That the manufacturing process is capable of producing quality product That throughout product shelf life and life cycle commercial batches will link to clinical batches in all relevant aspects These can be accomplished by Process development and control strategy according to traditional standards Process development and control strategy according to new paradigm Regulatory AssessmentAPI and Formulation API- Assessors’ Evaluation Have starting materials and process been adequately described? Are there toxicity concerns with degradants and/or related substances? Have adequate specifications and methods been proposed? Have adequate process controls been described? Was the design space adequately developed and data provided to support it? Assessors’ Evaluation of the Case Study Formulation Why was Calcium Hydrogen Phosphate Hydrate chosen with a water sensitive API? Concern about compatibility and stability Has material variability effects been understood? Adequacy of NIR testing Adequacy of dissolution model and method What is the function of D-mannitol in the formulation? Described only as excipient i