Reviews
This is a book worth reading for anyone preparing for GMP. Since gathering relevant information domestically is still difficult, I found this book feeling like finding a needle in a haystack, but it is better than I expected. It is hard to find materials for the 2016 version of 13485 other than this book, so I am glad that at least this one exists. Since there is currently nothing to compare it to, I am thinking that this book should be considered the best option available. Anyone looking for
Points to note for companies preparing for GMP.
Shin Gyu-cheol: Introduction to and Practice of Medical Device GMP
"Introduction and Practice of Medical Device GMP" was designed for use in GMP classes for manufacturing practitioners preparing for the establishment of U.S. cGMP and ISO 13485 transition audits, as well as for students in biomedical engineering departments at specialized medical high schools and universities. The structure groups ISO 13485, the Standard for Manufacturing and Quality Management of Medical Devices, and PART 820-QSR requirements according to the general business processes of manufacturers, and for each chapter, diagrams explain which process within the overall main process the requirements of that chapter correspond to.
Korean title: 의료기기 GMP 개론 및 실무
Korean author: 신규철
Korean publisher: 한국학술정보
ISBN-13: 9788926878040
Reviews
This is a book worth reading for anyone preparing for GMP. Since gathering relevant information domestically is still difficult, I found this book feeling like finding a needle in a haystack, but it is better than I expected. It is hard to find materials for the 2016 version of 13485 other than this book, so I am glad that at least this one exists. Since there is currently nothing to compare it to, I am thinking that this book should be considered the best option available. Anyone looking for
Points to note for companies preparing for GMP.
