Actual Construction and Operation of PV Systems/Processes Following a Process Approach - <ebook + Printed Version>
In EU pharmacovigilance operations, the establishment of a quality system based on Module I is mandatory; however, many organizations still lack sufficient implementation and development of such systems. This document explains the fundamental understanding of ISO 9001 and Module I, as well as the actual process construction and operation, audits, and CAPA responses, based on a process approach! It is a recommended read for everyone involved in global PV operations. ■ Key points of this document: 【1】 The explanation is structured along the flow of practical work, making it easy for beginners to understand! Written by an author with many years of experience in PV operations and training at major pharmaceutical companies, this is a textbook on quality systems in PV. 【2】 It complements deficiencies using ISO 9001, which is consistent with Module I. 【3】 PV audits and CAPA responses: ■ In PV audits conducted by organizations independent of the PV department, it is required to possess the capability to evaluate the effectiveness and performance of the system and processes. ■ In reality, there are still many cases where there are issues with root cause analysis, impact assessment, and the content of CAPA.
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■Author Takamitsu Shibuya ■Table of Contents Chapter 1 Overview of ISO 9001 and Module I 1. ISO Standards 2. Overview of ISO 9001 3. Overview of Module I 4. Comparison of ISO 9001:2008 and Module I 5. Documentation and Record Keeping 6. Management Review Chapter 2 Building a PV Business Management System and Quality System 1. Mission, Products, Customers, Stakeholders, Environmental Trends 2. Quality Policy, Quality Objectives 3. Process Development 4. Operation of Systems and Processes 5. Audits 6. Improvement (Addressing Abnormalities and Issues as well as Unfavorable Situations: CAPA)
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