[書籍] 【ebook】 Implementation and operation of Quality Management System based on EU GVP Module1/ISO9001 requirements
Implementation and operation of Quality Management System based on EU GVP Module1/ISO9001 requirements
~Construction and operation of PV system / Process based on process approach~
～Audit planning and implementation with the introducing of QMS,and CAPA preparation~
you can use it as a textbook for training!!
Based on the current situation where the PV business system has not been established at overseas branch offices and overseas PV business consignees,
the overseas version (English version) will be published!
You can use it even if you can't understand Japanese.
Useful for QMS training conducted overseas.
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（ I'm sorry, but the description is in Japanese）
- The EU regulatory authority requires the introduction of a QMS -
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. This book is organized according to the actual flow in building and operating PV systems and processes in the process approach.
It introduces the audit planning and implementation with the introducing of QMS,and CAPA preparation
based on the experience of the author, who has been involved in PV work and guidance for many years at a major pharmaceutical company.
We recommend it for everyone involved in global PV business！
From the description of Module I, the EU regulatory authority requires the introduction of a QMS based on the development and operation of systems and processes in order to plan and execute PV operations. ※Companies that need to respond：
・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
・The companies that outsource all or part of PV operations related to these medicines
■Features of this book 【１】Easy to understand even for beginners with explanation of the structure along the actual flow！ This book introduces the specific methods used to introduce and operate QMS based on the experience of the author, who has been involved in PV work and guidance for many years at a major pharmaceutical company.
⇒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.
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.
【2】Complement the shortage Using ISO9001, which is consistent with Module I
⇒At the moment, it is difficult to build and maintain the required level of the quality system from the requirements of Module I. ISO9001 is used to compensate for the shortage,and the quality system required by Module I and its construction are explained in this book.
【３】PV audit and preparation and management of CAPA ■To perform the PV audit, an independent auditing organization is required, whose auditors are familiar with regulations such as laws, guidelines, and requirement levels, and well-versed in the field to be audited.
■At the moment, there are still many cases that include problems with root cause analysis, impact evaluation, and CAPA content.
⇒Representative examples of the problems the author have experienced in audits conducted in Japan and other countries so far are described.
※An example of a problem case in CAPA
・Insufficient or inappropriate root cause analysis, impact evaluation, or insufficient description
・Insufficient content or description of CAPA
・ CAPA execution control is not implemented or is insufficient
・ Top management of the PV organization is not sufficiently involved in CAPA control
Pharmacovigilance QMS consultant and pharmacovigilance auditor
IRCA Certified QMS2015 Principal Auditor
【INTRODUCTION OF AUTHOR】
Left Chugai Pharmaceutical Co.Ltd
Drug Safety Coordination Department Drug Safety Division
Global PV Quality Manager
Introduced pharmacovigilance QMS
Regulatory Affairs Audit Department
Audit Strategy Head for pharmacovigilance
Integrated headquarters’ and affiliates’ clinical audit organizations as global organizations
Introduced and managed pharmacovigilance audits
Secondment to quality assurance organization of F. Hoffmann-La Roche
Manager of pharmacovigilance organization Head Office
Managed to create and maintain safety reference documents
Managed to develop an IT system for ICSR processing
Managed to develop a database system for medical information
Staff of the pharmacovigilance organization Head Office
Managed to develop an IT system for statistical analysis
Managed and implemented data management
Managed and implemented Japanese reexamination from planning to submission to the Health Authority
Implemented ICSR processin
Joined Chugai Pharmaceutical Co. Ltd
Supported investigator-initiated clinical trials/studies from the science side
■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.
CHAPTER 1 OVERVIEW OF ISO9001 AND MODULE I
1. ISO standards
2. Overview of ISO9001
2.1.2 Quality in terms of product life cycle
2.1.3 Quality from the customer’s perspective
2.2 Management and management systems
2.2.1 Management （system） and quality management （system）
2.2.2 Study of the introduction of QMS
2.3.1 Changes in requirement levels
2.3.2 Quality assurance in the process approach
3. Outline of Module I
3.1 Configuration of Module I
3.2 Relationship between PV systems and quality systems
4. Comparison between ISO9001：2008 and Module I
4.1 Similarities between ISO9001：2008 and Module I
4.2 Differences between ISO9001：2008 and Module I
5. Documentation and recordkeeping
5.2 Retention of records
6. Management review
CHAPTER 2 Establishment of PV business management systems and construction of quality systems
1. Mission, product, customer, interested party, environmental trend
1.1 PV product
1.2 Customer and interested party determination and understanding of expectations and requirements
1.3 Understanding the environment
1.4 Key points of the survey and analysis
2. Quality policy and objectives
2.1 What is quality?
2.2 What is quality in PV regulations?
2.3 Quality policy and quality objectives
2.3.1 The role of quality policy and quality objectives
2.3.2 Setting quality objectives
220.127.116.11 Setting an appropriate timeline
18.104.22.168 Setting quality objectives
22.214.171.124 Means for achievement
2.4 Drafting an execution plan for quality objectives（quality plan）
2.6 Execution control of quality plan
2.6.1 Executing the plan
2.6.2 Gantt chart and arrow diagram
2.6.3 How to prepare an arrow diagram
3. Process development
3.1 Difference between process and procedure
3.2 Management on an organizational basis and a process basis
3.3 Interaction between production process and other processes
3.4 Process development and arrangement
A）Clarification of PV system configuration
A）-1 Clarification of regulations and requirements
A）-2 Product clarification
A）-3 Clarification of the required process
A）-4 Clarification of input and products in required processes, and interrelationships in the processes
B）-1 Extraction of quality requirements for the product and process
B）-2 Quality planning and designing
B）-2.1 Quality function deployment
B）-2.2 Case of quality design
B）-2.3 Deployment of required quality according to a tree diagram
B）-2.4 Deployment to quality elements
B）-2.5 Preparation of quality table
B）-3 Examination of mechanism/parts group that constitute the product and elements work/parts thereof
C）Deployment to process and preparation of procedure
C）-1 Deployment to process
C）-1.1 Drafting of the process and peripheral information
C）-1.2 Turtle diagram
C）-2 Analysis of necessary technology and resources
C）-3 Key point for quality assurance in the process
C）-4 Preparation of procedural document
C）-4.1 Operation standard in PV
C）-4.2 Considerations in preparation
C）-4.3 Reviewing risks in procedures
4. System and process operation
4.1 Resource management
A）-1 Preparation of job description
B）Facilities, Equipment and Apparatus
4.2 Procedural training
4.2.1 Process operation to prevent procedure violation
4.2.2 Implementation of procedural training
4.3 Ensuring compliance with procedure
4.3.1 Case of an accident due to non-compliance with procedures（1）4）
4.3.2 Case of accident due to non-compliance with procedures（2）5,6）
4.4 Error measure
4.4.1 Error caused by human characteristics
126.96.36.199 Error by social loafing
188.8.131.52 Other factors
4.4.2 Error elimination
4.5.1 Purpose of monitoring
4.5.2 Monitoring according to process characteristics
4.5.3 Control chart
184.108.40.206 X-R control chart
220.127.116.11 T-type matrix
4.6 Early process control
4.7 Variation point control
4.8 Change control
5.1 Audit plan
A）Strategic level audit planning
B）Tactical level audit planning
C）Operational level audit planning
5.2 Implementation of audit
A）Preparation of an audit agenda
C）Interviews and review of documents and records
5.3 Reporting of audit results
5.4 Analysis of audit results
5.5 Training of auditor
6. Improvement（handling abnormalities, problems, and unfavorable situations：CAPA）
6.1 Problems in the preparation and management of CAPA
6.1.1 Problems in CAPA preparation
6.1.2 Problems in CAPA management
6.2 Understanding the actual situation and status of the problem
6.4 Root cause analysis and impact assessment
6.5 Corrective action
6.5.1Response to recurrence prevention
6.5.2 Addressing root causes
6.5.3 Planning and implementation of corrective action
6.6 Preventive action
6.7 Execution of CAPA
6.8 Evaluation of CAPA effectiveness