DRUG QUALITY SYSTEM FOR THE 21ST CENTURY 第二十一世纪药品质量体系.pptVIP

DRUG QUALITY SYSTEM FOR THE 21ST CENTURYPQRI/FDA April 22-24 CHANGES WITHOUT PRIOR APPROVAL AN FDA PERSPECTIVE Dennis M. Bensley, Jr., Ph.D. Center for Veterinary Medicine, FDA OUTLINE INTRODUCTION BACKGROUND CURRENT FDA ASSESSMENT CURRENT RISK ANALYSIS COMPARABILITY PROTOCOL STRATEGIC GOALS CONCLUSION INTRODUCTION Changes Without Prior Review working group established by FDA’s Drug GMP Steering Committee Working Group members: -Ajaz Hussain, Co-chair (CDER) -Nancy Sager, Co-chair (CDER) -Kathy Jordan, Project Manager (CDER) -Nick Buhay (CDER) -Chris Joneckis (CBER) -John Finkbohner (CBER) -Dennis Bensley (CVM) -Nancy Rolli (ORA) -Patricia Alcock (ORA) -Marybet Lopez (ORA) -Janet Showalter (OC, OIP) -Lynn Whipkey (OC, OCC) INTRODUCTION Charge of Working Group: -examine current state of the supplemental change approval process, specifically those manufacturing changes requiring prior FDA approval. INTRODUCTION Charge of Working Group: -examine current state of the supplemental change approval process, specifically those manufacturing changes requiring prior FDA approval. -identify and recommend implementation of other means to reduce reporting requirements, for example the use of risk management tools, comparability protocols, product development information, and process control improvements (e.g., PAT). INTRODUCTION Purpose of Workshop -Present a summary of FDA’s current thinking and activities regarding the supplemental change approval process. INTRODUCTION Purpose of Workshop -Present a summary of FDA’s current thinking and activities regarding the supplemental change approval process. -Stimulate discussion and constructive feedback from stakeholders regarding the current and desired future state of the change approval process. BACKGROUND Legal Requirements - The applicant must notify FDA of each manufacturing change in accordance with section 506A of the Federal Food, Drug, and Cosmetic Act and, when finali