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Author: Mustafa Edik Publisher: CRC Press ISBN: 1003814042 Category : Medical Languages : en Pages : 474
Book Description
The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.
Author: Mustafa Edik Publisher: CRC Press ISBN: 1003814042 Category : Medical Languages : en Pages : 474
Book Description
The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.
Author: Dr. Naveed Naeem Quadri Publisher: OrangeBooks Publication ISBN: Category : Business & Economics Languages : en Pages : 98
Book Description
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.
Author: Karen Ginsbury Publisher: CRC Press ISBN: 9780935184600 Category : Medical Languages : en Pages : 408
Book Description
Focusing on the practical aspects of GMP auditing, Compliance Auditing for Pharmaceutical Manufacturers provides a hands-on approach for performing audits - what questions to ask and what answers to expect - that will save QA professionals and department heads alike time and effort while ensuring compliance. The amount of verbiage has deliberately been kept to a minimum. The purpose of any prose is to supplement the checklists by explaining how to use them and how to determine whether responses are satisfactory. After reading this manual, readers will be able to enter any department in their company or in any other company and perform an in-depth, effective, and efficient cGMP compliance audit. Features
Author: DIANE Publishing Company Publisher: DIANE Publishing ISBN: 9780788115899 Category : Languages : en Pages : 186
Book Description
Examines the extent to which drug manufacturers charge more for the same products in the U.S. than abroad. Also, studied manufacturers' "factory prices" and identified the causes of any documented price differentials. Compares factory prices for the top 200 frequently dispensed prescription drugs sold in both the U.S. and the U.K. 7 charts and tables.
Author: Lance B. Coleman Publisher: Quality Press ISBN: 1951058100 Category : Business & Economics Languages : en Pages : 417
Book Description
The value of the ASQ Certified Quality Auditor Handbook, Fifth Edition, is clear. It is designed to help new auditors gain an understanding of the field and prepare for the ASQ CQA exam. In addition, experienced auditors can refer to it as a helpful reference; audit managers and quality managers can rely on it for guiding their auditing programs; and trainers and educators can use it for teaching fundamentals. This in-depth overview of quality auditing represents auditing practices for internal and external applications. It provides practical guidance for both system and process auditors as well. Many current topics have been expanded to reflect changes in auditing practices since 2012, with guidance from the recent 2017 update of ISO 19011. In addition, readers will find example audit situations, stories, and review comments to enhance their understanding of the field. Topics covered include the common elements of all types of system and process audits (quality, environmental, safety, and health): Auditing fundamentals, including types of quality audits, purpose and scope of auditing, terms and definitions, roles and responsibilities of participants, and professional conduct The audit process, from preparation and planning, to performance and reporting, to follow-up and closure Auditor competencies, including resource management, conflict resolution, communication, interviewing, and team dynamics Audit program management and business applications, including staffing, training and development, program evaluation, organizational risk management, and best practices Quality tools and techniques, including problem-solving tools, process improvement techniques, basic statistics, verification, and validation "This book is an encyclopedia of all major bodies of information a new or experienced quality auditor would need. It covers both the qualitative and the quantitative, which is a strength. I can't think of a quality auditor that would not find this work helpful." Kim H. Pries, CRE, CQE, CSQE, CSSBB, CMQ/OE, CQA "This handbook will be helpful to those who are new to auditing or require more in-depth knowledge of the implementation of an audit program. Boxed examples or scenarios provide some of the practical challenges encountered during auditing." Govind Ramu, ASQ Fellow, Co-Author ASQ SSGB Handbook, Author ASQ CSSYB Handbook Lance B. Coleman, Sr. has over 25 years of leadership experience in the areas of quality engineering, Lean implementation, quality, and risk management in the Medical Device, Aerospace, and other regulated industries. He has presented, trained, and consulted throughout the United States and abroad. Lance is currently a Director of Quality for IDEX Health and Science, LLC, in Oak Harbor, Washington.
Author: Michael Hamrell Publisher: CRC Press ISBN: 9780367399337 Category : Languages : en Pages : 216
Book Description
This blue-chip guide adds quality to the pharmaceutical clinical development process by detailing the need for, and stressing the importance of, an independent audit of clinical data to protect participants and validate study results. Examines the use of personal computers, the Internet, and third-party organizations to assist in data validation! Positioning the audit as the only reliable tool to verify that a drug has been shown to be safe and effective in clinical trials, The Clinical Audit in Pharmaceutical Development recommends establishing auditing and quality assurance at the beginning of a clinical study describes Good Clinical Practices (GCPs) and the role of regulatory agencies in the review, validation, and auditing processes outlines the clinical process, from trial design through report writing compares and contrasts United States and international regulatory statutes identifies monitoring as the key to guaranteeing high-quality data focuses on the role of the clinical audit in achieving unity in a multinational study discusses the worldwide influence of the US Food and Drug Administration audit analyzes findings from previous FDA clinical audits to reveal trends and future directions provides guidelines for fraud detection and considers the ramifications of falsified data and more! Confirming that all clinical information has been properly collected and reported, The Clinical Audit in Pharmaceutical Development is a crucial reference for clinical and research pharmacists and pharmacologists; biostatisticians; clinical research associates, coordinators, and investigators; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.
Author: Mustafa Edik
Author: Mustafa Edik
Author: Dr. Naveed Naeem Quadri
Author: Karen Ginsbury
Author: Pharmaceutical Quality Group
Author: DIANE Publishing Company
Author: Karen Ginsbury
Author: Pharmaceutical Quality Group
Author: Lance B. Coleman
Author: Minal Ghante
Author: Michael Hamrell