|
|
22,000円(税込)
This book is written based on the author's extensive experience in pharmacovigilance (PV) work at a major pharmaceutical company. The author introduces methods for implementing Quality Management Systems (QMS) using a process approach, describes the methodologies employed in these processes, and highlights key considerations.
EU GVP Module I (Pharmacovigilance systems and their quality systems) is a guideline that outlines the requirements related to quality systems in pharmacovigilance and has been published for over seven years. PV departments of pharmaceutical companies with headquarters or branches in the EU, PV departments of their license partners who have authorized medicines for human use in the EU, and companies that outsource all or part of PV operations related to these medicines have developed quality systems in accordance with Module I provisions as a legal obligation.
However, many organizations have not yet fully implemented or maintained these quality systems, and in some cases, fully understanding the requirements of Module I is not considered essential. Therefore, this book explains the quality system required by Module I and its construction.
The quality system referred to in Module I is substantially equivalent to a quality management system, but it is difficult to build and maintain the required level of quality system based solely on the requirements of Module I. Therefore, supplementation with ISO9001, which is consistent with Module I, is indispensable to compensate for any shortcomings. With the revision from the 2008 to 2015 edition, recommendations were incorporated into requirements, some requirements were deleted, clauses were reorganized, etc., but the essence has not changed since the 2008 edition.
This book is not an in-depth article explaining Module I and ISO9001. Instead, it is organized according to the actual workflow in building and operating PV systems and processes using the process approach. The author hopes that organizations planning to build and operate PV systems and processes in the future, as well as those that have already operated them, can review their current systems, process structures, and operations with reference to this book.
|
