GMP For Pharmaceuticals (Seventh Edition) Pdf
This book contains information obtained from authentic and highly regarded sources. Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use. The authors and publishers have attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained.
This book is dedicated to my dad, Roy Bernard Bunn, of Wymondham, Norfolk, England. Without his encouragement to “Do what you love and love what you do,” I would not be writing chapters in this book today. Pharmacy, medicines, quality, and most of all patient focus have been my entire career, and I would not change anything.
There have been many changes in the world of pharmacy since I started making medicinal products in the Norfolk and Norwich hospital pharmacy during the early 1970s. The changes include advances in pharmacology, discovery of new treatments, and changes in manufacturing processes technologies, with significant increase supporting documentation requirements. Building on the vast information and reputation of original authors and further developed in the 6th edition edited by Joe Nally, I have taken the opportunity to reorganize this 7th edition to collate the related regulation parts. In addition to the core regulatory chapters, I have added new related chapters (Chapters 3, 19, 23, and 24) to provide readers with additional insight and supporting information.
These new chapters include the current regulatory focus for Management Responsibilityand Control, Microbiological Aspects of Pharmaceutical Aseptic Processing in the Compounding Pharmacy, Worldwide Good Manufacturing Practices, and Data Integrity and Fundamental Responsibilities. In addition, FDA regulatory inspections and enforcements have been refocused into three new chapters by the contributions from Alson and Bird LLP, Washington Attorneys. I am privileged to have worked with many distinguished colleagues with outstanding expertise and experience in pharmaceuticals, quality, and regulatory compliance. My special thanks goes to the authors for their time and contributions to this book from over 360 years of experience and making this an exceptional 7th edition.
Editor
Graham P. Bunn is the president of GB Consulting LLC, in Pennsylvania, a company providing regulatory compliance, quality systems, regulatory action remediation, training and technical consulting services for pharmaceutical, biotechnology and other FDA and European Medicines Agency (EMA)-related industries. Before founding GB Consulting LLC, Graham gained broad good manufacturing practices (GMP) and FDA inspection experience through his work in the pharmaceutical industry, including working for SmithKline Beecham PLC (GlaxoSmithKline PLC), Wyeth Pharmaceuticals (Pfizer), and Astra Merck Inc. (AstraZeneca PLC). His career experience includes management positions and responsibilities as a corporate quality auditor and in quality assurance, validation, and clinical trials manufacturing and packaging. He has developed and facilitated numerous highly interactive learning and training workshops worldwide. Graham is also the author of several book chapters and journal articles. A member of the Regulatory Affairs Professional Society (RAPS). Graham received a BSc in pharmacy from Brighton University, England, and an MSc in quality assurance and regulatory affairs from Temple University, in Philadelphia.
Tags:
book