Case study details the right way and the wrong way to successfully develop and market a new drug
Beginning 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 Processes
- FDA Code of Federal Regulations' 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.
Contents
Part 1 : The Event
CHAPTER 1 - Francesca
Part 2 : Drug Discovery: Five Years Earlier
CHAPTER 2 - Katlin BioScience: Transgenic Mouse Study
CHAPTER 3 - Oxy‐Fox Inhaler
Part 3 : Kinnen Oxy‐Fox Inhaler Market Launch Program
CHAPTER 4 - Agency IND and NDA Requirements, Six Sigma
Charter, and Device Master Record
CHAPTER 5 - Meeting Minutes Guidelines
CHAPTER 6 - Project Timing, Marketing Plan, and Offshore
Molding
CHAPTER 7 - cGMP Process Validation Requirements
CHAPTER 8 - Failure Mode Effects Analysis
CHAPTER 9 - Design for Manufacturability, Design for Six
Sigma, Concurrent Design
CHAPTER 10 - Design Fishbone Diagram
CHAPTER 11 - Product Specifications
CHAPTER 12 - Design Control
CHAPTER 13 - Design of Experiments (DOE)
CHAPTER 14 - Start‐Up Issues
Part 4 : Present Day: Funeral
CHAPTER 15 - Grief
CHAPTER 16 - The Autopsy Results
CHAPTER 17 - The Agency
Part 5 : Agency Medical Event Letter
CHAPTER 18 - Kinnen Notification
CHAPTER 19 - Investigation Team Management
CHAPTER 20 - DMAIC Investigation Process
CHAPTER 21 - Internal Quality Review
CHAPTER 22 - The Agency Audit Letter
CHAPTER 23 - Agency Arrival
CHAPTER 24 - The Audit
CHAPTER 25 - End‐of‐Day Agency Wrap‐Up Meeting
CHAPTER 26 - Kinnen Management Review
Part 6 : Reckoning
CHAPTER 27 - Blame and Responsibility
CHAPTER 28 - Closure
Bibliography
Index
0 comments:
Posting Komentar