Bhusari k p (4 Ergebnisse)

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Soft cover. Zustand: New. Contents Preface I Guidelines in Pharmaceuticals 1 Introduction to Clinical Pharmacy 2 Audit Guide Line formats for pharmaceutical excipients 3 Good Laboratory practices 4 Good clinical practice guidelines 5 Hazard and risk analysis in pharmaceutical products 6 Validation Protocols 7 Pharmaceutical Inspections II Regulations in Pharmaceuticals 8 The Consumer Protection Act 1986 9 The Environment Protection Act 1986 10 Scale up and Post Approval Changes III Quality Management in Pharmaceuticals 11 Quality Management System for API?s GMP and ISO 12 Process Analytical Technology 13 Quality Risk Management 14 Quality Management of Cosmetics Bibliography IndexThe global market associated with pharmaceuticals has progressed enormously since last few decades The quality and economy of a pharmaceutical product became an essential aspect for its existence and fulfillment of global requirements It is also a concern for various regulatory agencies all over the world Pharmaceutical manufacturer has to produce the products that meet the prescribed standards of certain international regulatory agencies and local government These agencies provide guidelines and set various regulations for the pharmaceutical manufacturers to get quality products In concern with all these facts quality assurance and quality management became a specialized area of study that deals with the practices to be adopted during the manufacturing of pharmaceuticals This book deals with all the elements of quality assurance and managementSalient Features Presented the information in condensed cohesive form Covers different validation protocols for various processes methods and equipments involved in the manufacturing Involved pharmaceutical inspections various regulatory acts Explained the quality management system and its role 562 pp.…

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Zustand: New. &Uumlber den AutorrnrnK. P. Bhusari M. Pharm, Ph.D. is Principal and Professor, Sharad Pawar College of Pharmacy, Nagpur (Maharashtra). He has 30 years teaching experience and 16 years research experience in the field of Pharmacy. He has publis.