Orange Handbook of Internal Auditing for Pharmaceutical Industry

Book excerpt: This is book is written to understand concept of Internal Audit in very easy and simple way, focusing on facilities, operations, quality systems and procedures to ensure the compliance with respect to current Good Manufacturing Practices (cGMP) and regulatory requirements and to recommend Corrective Actions for improvement / upgrade of Quality Management System (QMS) in pharmaceutical and other healthcare industry. Either you are auditor, auditee, student or representative from top management or any of pharmaceutical department, this book will help you to understand the process of auditing the pharmaceutical industry. To make learning simply, I have tried to make this book handy, short and simple. At appropriate place of book, motivational quotes from great personality have been added, which is one of unique concept for book of this kind. Hence this book is written as part of installments for GMP auditing concept, so first installment series is dedicated to internal audit, upcoming series will cover second party (Vendor audit) audits and third party independent (Audit by Regulatory agency) auditing organization.