Manufacturing pharmaceuticals is one of the most regulated human endeavours.The reason is that patients rightly expect pharmaceutical products to be correctly labeled and to be safe, pure and effective. The same expectation applies to veterinary products. The manufacturers of pharmaceutical products have a legal responsibility to keep their operations under control and to control the quality of their products. Good control is also good business,as yields will be consistent, failures will be minimal, and facilities and processes will remain Þt for purpose. Change control is about the managed change of personnel, procedures, processes, premises and product quality. Most regulations have been imposed on the industry following incidents and accidents. Most signiÞcantly, there is a mandatory quality system used to control the manufacture of pharmaceutical products known as current Good Manufacturing Practice (cGMP) , and the preÞx “c” reminds us that practices are constantly improving. Change control is a critical part of cGMP and, like all aspects of quality management, should be continuously improved. Change control is deÞned as a formal system by which qualiÞed representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment and processes. Done properly, validation and qualiÞcation procedures operate alongside change management and represent a planned, documented and science-based approach to the introduction of new systems and changes to existing systems. The systems can be physical and procedural. This unique book gives manufacturers the necessary insight to improve the management of change, and covers the technical and management skills that are required. The complexity of modern pharmaceutical facilities means that no single person can be sufÞciently knowledgeable in all facets of the business, and this is exempliÞed in the range of multidisciplinary skills that have had to be marshalled to produce this comprehensive book. The authors of the chapters are established experts and the full range of topics and examples are covered in the text. Having spent more than 30 years in many aspects of pharmaceutical manufacture, I can appreciate the importance and value of this book and I am proud to be associated with it. This book will beneÞt design, construction,validation and maintenance engineers; control system software and hardware specialists; development scientists; production managers,supervisors and operators; as well as quality assurance professionals. It Copyright 2004 by CRC Press LLC. enables us to appreciate the process of change control, and thus minimizes the number of occasions when there are losses in quality, time and opportunity.
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