Modern Aspects of Pharmaceutical Quality Assurance: Developing & Proposing Application Models, Sops, Practical Audit Systems for Pharma Industry
Ghante, Minal, Potdar, Manohar, Bhusari, Vidhya
- 出版商: Springer
- 出版日期: 2024-03-12
- 售價: $4,660
- 貴賓價: 9.5 折 $4,427
- 語言: 英文
- 頁數: 523
- 裝訂: Hardcover - also called cloth, retail trade, or trade
- ISBN: 9819992702
- ISBN-13: 9789819992706
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商品描述
The pharmaceutical quality system ensures that the process performance is suitably achieved, the product quality is regularly met, improved opportunities are identified and evaluated, and the knowledge is constantly expanded. Auditing also plays a crucial role within the pharmaceutical industry. It helps to assess and review quality to improve and build a better system for the benefit of companies.
This book aims to develop a tool that will substantially decrease the number of Inspectional Observations and Warning letters, thus eliminating Import Alerts and Consent Decree. This book targets the Pharmaceutical Industry and students of Pharmaceutical Quality Assurance so they can get in hand-ready consolidated information on Pharmaceutical Quality guidelines, Quality metrics, and implementation of simplified SOP guidelines, plant layouts to implement Quality metrics for Pharmaceutical Manufacturing systems in tablets, capsules, liquid orals, and semi-solid dosage forms.
The chapters cover the various aspects of Pharmaceutical Quality Assurance. The selection of topics is mainly based on the requirements of Pharmaceutical regulatory guidelines of India, the UK, the USA, Australia, and South Africa. Each chapter includes the abstract, detailed explanation, implementation guidelines, flowcharts, layouts, and Standard Operating Procedure of quality metrics for the Pharmaceutical Manufacturing System商品描述(中文翻譯)
製藥品質系統確保適當實現流程績效，定期達到產品品質，識別並評估改進機會，並不斷擴充知識。審計在製藥行業中也扮演著關鍵角色。它有助於評估和審查品質，以改進並建立更好的系統，造福企業。
本書旨在開發一個工具，大幅減少檢查觀察和警告信的數量，從而消除進口警報和同意書。本書針對製藥行業和製藥品質保證學生，提供關於製藥品質指南、品質指標以及簡化標準操作程序指南的相關資訊，以實施製藥製造系統中片劑、膠囊、液體口服劑和半固體劑型的品質指標。
各章節涵蓋製藥品質保證的各個方面。選題主要基於印度、英國、美國、澳大利亞和南非的製藥監管指南的要求。每個章節包括摘要、詳細解釋、實施指南、流程圖、佈局和製藥製造系統的標準操作程序的內容。
作者簡介
Dr. Minal R. Ghante is presently working as I/c Principal and professor in Smt. Kashibai Navale College of Pharmacy, Pune. Her research areas include Quality Assurance, regulatory audits, drafting of Validation Protocols, Analytical method development, and validation by HPLC, LC-MS/MS, HPTLC, and Stability/Degradation Studies of APIs & Pharmaceutical Products. She has over 18 years of teaching and research experience at the undergraduate & postgraduate levels. She has more than 35 research publications in various Journals of National & International repute & authored/co-authored 12 books to her credit. She has presented more than 30 posters in multiple symposia/conferences. She is a recognized Ph.D. guide & Postgraduate Teacher at Savitribai Phule Pune University; 40 PG students have completed dissertations under her guidance.
Dr. Manohar Anant Potdar is currently a Professor Emeritus in Smt. Kashibai Navale College ofPharmacy, Pune. His research areas include Plant Design and Operation, Production planning and Control systems, Pharmaceutical Validation, Good Manufacturing Practices, Plant Administration, Quality Assurance Techniques, Quality Planning and Analysis., Quality Management Systems, Pharmaceutical Quality Audits, and Regulatory Affairs. He has 33 years of industrial experience and ten years of teaching experience. He has authored nine technical books and nine library books. He is an approved guide for M.Pharm and Ph.D. and has mentored 34 M. Pharm students and one Ph.D. student for dissertation work. He is an expert in Production and Operation Management, Quality Assurance and Validation-Audits, Project Management, and Employee Training.
Dr. Vidhya Bhusari is an Associate Professor in Smt. Kashibai Navale College of Pharmacy, Pune. She has completed her Ph. D & M. Pharm from Bharati Vidyapeeth University, Pune, and has secured M. Pharm first classwith distinction. Her research areas include Quality Assurance, Analytical Method Development, and Validation by HPLC, LC-MS/MS, HPTLC, and Stability/Degradation Studies of APIs & Pharmaceutical Products. She has around five years of teaching experience and about six years of industrial experience. She has more than 40 research publications in various journals of International repute. She has authored one book to her credit. She has presented five posters and papers in multiple symposia/conferences. She has guided 12 M. Pharm students for their dissertation.
作者簡介(中文翻譯)
Dr. Minal R. Ghante目前擔任普那的Smt. Kashibai Navale藥學院的代理校長和教授。她的研究領域包括質量保證、監管審計、驗證協議的起草、高效液相色譜、液相質譜、高效薄層色譜以及活性成分和藥品穩定性/降解研究的方法開發和驗證。她在本科和研究生階段擁有超過18年的教學和研究經驗。她在國內外各種期刊上發表了35多篇研究論文，並撰寫/合著了12本書。她在多個研討會/會議上展示了30多個海報。她是薩維特里拜普內普大學的認可博士導師和研究生教師；在她的指導下，有40名研究生完成了論文。
Dr. Manohar Anant Potdar目前是普那的Smt. Kashibai Navale藥學院的名譽教授。他的研究領域包括工廠設計和運營、生產計劃和控制系統、藥品驗證、良好製造實踐、工廠管理、質量保證技術、質量計劃和分析、質量管理系統、藥品質量審計和監管事務。他擁有33年的工業經驗和十年的教學經驗。他撰寫了九本技術書籍和九本圖書館書籍。他是M.Pharm和Ph.D.的指導教師，指導了34名M.Pharm學生和一名Ph.D.學生的論文工作。他是生產和運營管理、質量保證和驗證審計、項目管理和員工培訓方面的專家。
Dr. Vidhya Bhusari是普那的Smt. Kashibai Navale藥學院的副教授。她在Bharati Vidyapeeth大學完成了她的博士學位和藥學碩士學位，並獲得了優異的成績。她的研究領域包括質量保證、高效液相色譜、液相質譜、高效薄層色譜以及活性成分和藥品穩定性/降解研究的方法開發和驗證。她有約五年的教學經驗和約六年的工業經驗。她在國際知名期刊上發表了40多篇研究論文。她撰寫了一本書。她在多個研討會/會議上展示了五個海報和論文。她指導了12名藥學碩士學生的論文。
