■Purpose of this book
◎This book was explained based on the experience of the author, who has been involved in PV work and guidance for many years at a major pharmaceutical company.
From the author's point of view, this book introduces the method of introducing QMS according to the process approach, the method used in the process, and the key points.
It presents an overview of methods and tools that the author considers particularly useful for a variety of measures.
■By the “INTRODUCTION”
The EU GVP Module I -Pharmacovigilance systems and their quality systems (hereinafter referred to as Module I) is a guideline that describes the requirements related to the quality system (hereinafter referred to as the quality system) in pharmacovigilance (PV) and has been published for over seven years. The PV departments of pharmaceutical companies with head offices or branches in the EU, the PV departments of their license partners, which have authorized medicines for human use in the EU, and the companies that outsource all or part of PV operations related to these medicines, (hereinafter, the PV Department of Pharmaceutical Company and the company outsourced PV operations are collectively referred to as an organization) developed a quality system according to Module I provision as a legal obligation.
However, many organizations have not yet fully introduced or maintained the quality system, and there are cases where fully understanding the requirements of Module I is not considered essential. Therefore, the quality system required by Module I and its construction are explained in this book.
The quality system referred to in Module I is substantially equivalent to the quality management system, and it is difficult to build and maintain the required level of the quality system from the requirements of Module I. Therefore, as supplementation with ISO9001 is indispensable, ISO9001, which is consistent with Module I, is used to compensate for the shortage. With the revision from 2008 to 2015 edition, incorporating recommendations into the requirements, deleting some requirements, reorganizing the clauses, etc. were conducted, but the essence has not changed since the 2008 edition.
This book is not an in-depth article explanation of Module I and ISO9001. However, it is organized according to the actual flow in building and operating PV systems and processes in the process approach. It would be greatly appreciated if the organizations that will build and operate PV systems and processes in the future, as well as those that have operated them, can review the current systems, process structures, and operations with reference to this book.