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Pharmaceutical Quality Assurance and Management
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The 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 management.
Salient Features:·
Presented the information in condensed and cohesive form
· Covers different validation protocols for various processes, methods and equipments involved in the manufacturing
· Involved pharmaceutical inspections, various regulatory actsExplained the quality management system and its role
Contents
Part 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, Part II Regulations in Pharmaceuticals: 8. The Consumer Protection Act, 1986, 9. The Environment (Protection) Act, 1986, 10. Scale up and Post Approval Changes, Part 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
About the Author
K. 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 published many research papers and articles. He has also worked in Nagpur University as Member of Senate and Management Council, Academic Council, Faculty of Medicine and Standing Committee.
U. D. Shivhare B.Pharm, M.Pharm, Ph.D. is Professor, Sharad Pawar College of Pharmacy, Nagpur. He has about 23 years of Teaching and 12 years of Research experience in the field of Pharmacy. He has guided many PG scholars and presently five Ph.D students are enrolled under his guidance. During his career, he has published a book and many research papers in international journals. He has also attended many national and international conferences during the tenure and received best paper awards in few of them.
D. C. Goupale M.Pharm is Asst. Professor; Bansal College of Pharmacy, Bhopal. He has about 10 years of teaching and 3 years of Industrial experience in the field of Pharmacy. Earlier he has published a book and about 13 research papers in various national and international journals.
Salient Features:·
Presented the information in condensed and cohesive form
· Covers different validation protocols for various processes, methods and equipments involved in the manufacturing
· Involved pharmaceutical inspections, various regulatory actsExplained the quality management system and its role
Contents
Part 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, Part II Regulations in Pharmaceuticals: 8. The Consumer Protection Act, 1986, 9. The Environment (Protection) Act, 1986, 10. Scale up and Post Approval Changes, Part 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
About the Author
K. 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 published many research papers and articles. He has also worked in Nagpur University as Member of Senate and Management Council, Academic Council, Faculty of Medicine and Standing Committee.
U. D. Shivhare B.Pharm, M.Pharm, Ph.D. is Professor, Sharad Pawar College of Pharmacy, Nagpur. He has about 23 years of Teaching and 12 years of Research experience in the field of Pharmacy. He has guided many PG scholars and presently five Ph.D students are enrolled under his guidance. During his career, he has published a book and many research papers in international journals. He has also attended many national and international conferences during the tenure and received best paper awards in few of them.
D. C. Goupale M.Pharm is Asst. Professor; Bansal College of Pharmacy, Bhopal. He has about 10 years of teaching and 3 years of Industrial experience in the field of Pharmacy. Earlier he has published a book and about 13 research papers in various national and international journals.
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