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Informationen zum Autor Dipak Kumar Sarker is the author of Quality Systems and Controls for Pharmaceuticals, published by Wiley. Klappentext Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models.Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice.The author has both industry and academic experience and many 'best practice' examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice. Zusammenfassung Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models.Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice.The author has both industry and academic experience and many 'best practice' examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice. Inhaltsverzeichnis Preface xi List of figures xv List of tables xix Glossary of terms and acronyms xxi Glossary of mathematical and statistical symbols xxiii SECTION A Most Suitable Environment 1 1. Introduction 3 1.1 The process of finding new lead medicines 4 1.2 A drug discovery framework 6 2. Technology transfer and the climate of change 11 2.1 Innovation and research 11 2.2 Method transfer 14 3. Quality systems structure and a maximum quality environment 15 3.1 The quality gurus and models for assurance 18 3.2 A cycle of continual improvement 22 3.3 Management structure and a functioning department 22 SECTION B Setting Process Bounderies 29 4. Validation 31 4.1 Process and manufacturing validation activities 35 4.2 Valid analytical methodologies (VAMs) 43 5. Good manufacturing practices 57 5.1 Manufacture of standard products 60 5.2 Manufacture of materials requiring specialised production facilities 75 5.3 Quality assurance aspects of medical gases, devices and miscellaneous product manufacture 88 6. Process control via numerical means 97 6.1 Charting and quality inspection 99 6.2 Sampling plans 104 6....
