A History of a cGMP Medical Event Investigation

Michael A. Brown 지음

Wiley 2012년 11월 27일 출간

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Case study details the right way and the wrong way to successfully develop and market a new drugBeginning with the untimely death of a young mother, A History of a cGMP Medical Event Investigation unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization.From initial transgenic mouse studies to the FDA fatality investigation, this case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug, including:FDA Investigational and New Drug Application ProcessesFDA Code of Federal Regulations#39; current Good Manufacturing Practice (cGMP)ISPE Good Automated Manufacturing Practice (GAMP)Readers will also be introduced to a variety of managers and researchers whose personal agendas conflict with best practices and therefore compromise the safety and effectiveness of a new drug product. Throughout the case study, the author offers tested and proven practices and tips so that these human flaws are not translated into drug product flaws. These practices and tips are critical and typically can only be learned through years of experience working in competitive drug development environments.A History of a cGMP Medical Event Investigation is ideal for students in biotechnology, pharmacology, engineering, and business management as well as professionals in biomedical and drug development. All readers will discover what can go wrong in developing and bringing a new drug to market. Most importantly, they will also learn how to apply Six Sigma principles and methods to ensure safe and effective product design, development, and manufacturing.

목차

Preface xiPart One The Event 11 Francesca 3Part Two Drug Discovery: Five Years Earlier 92 Katlin Bioscience: Transgenic Mouse Study 113 Oxy-Fox Inhaler 213.1 Kinnen Laboratories 213.2 Kinnen Laboratories: Oxy-Fox Transfer 223.3 Due-Diligence Team and Katlin Data Acceptance 23Part Three Kinnen Oxy-Fox Inhaler Market Launch Program 254 Agency IND and NDA Requirements, Six Sigma Charter, and Device Master Record 274.1 Launch Team Meeting Number 1 274.2 Meeting with Medical Affairs: Toxicity Studies 465 Meeting Minutes Guidelines 495.1 Launch Team Meeting Number 2 496 Project Timing, Marketing Plan, and Offshore Molding 556.1 Launch Team Meeting Number 3 556.2 Project Financial Review 616.3 Progress Meeting: Who Takes Credit for What? 646.4 Morning Meeting: Just-in-Time Manufacturing 657 cGMP Process Validation Requirements 697.1 Launch Team Meeting Number 4 698 Failure Mode Effects Analysis 818.1 Launch Team Meeting Number 5 819 Design for Manufacturability, Design for Six Sigma, Concurrent Design 939.1 Product Development Meeting Number 1 939.2 Update Meeting with Ed Chase and Gordon Taylor 10210 Design Fishbone Diagram 10510.1 Launch Team Meeting Number 6 10511 Product Specifications 11111.1 Product Development Meeting Number 2 11112 Design Control 11512.1 Design Team Meeting Number 7 11512.2 Product Development Staff Meeting 11812.3 Engineering One-on-One 11912.4 Program Update 12013 Design of Experiments (DOE) 12313.1 Molding Team Meeting 12314 Start-Up Issues 12914.1 Oxy-Fox Inhaler Wrap-Up and Equipment Start-Up 12914.2 The Final Management Review 135P

작가정보

저자(글) Michael A. Brown

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MICHAEL A. BROWN, PhD, PE, is a Visiting Professor at the University of Illinois at Chicago. Dr. Brown has twenty#45;five years#39; experience in the biomedical industry in a product and process design capacity with responsibilities for worldwide engineering and management. He has served as a lead engineer on numerous products, process, and equipment projects including design, implementation, and qualifications. He is a registered Professional Engineer and a certified Six Sigma Black Belt with considerable experience in team leadership. The material presented in this case, including the FDA regulations and Six Sigma concepts, was tested in an engineering senior design course taught by Dr. Brown over a three#45;year period. Student feedback noted that the difficult design principles were explained in an easy#45;to#45;read story that introduced them to the Six Sigma methodologies in an engaging manner.