About The Book
The recent year has witnessed an upsurge in applications of Industrial Pharmacy, keeping in view of scale-up, technology transfer and regulatory aspects. The most significant goal of writing this content is to outline the most relevant details regarding various pharmaceutical processes and aspects of Industrial Pharmacy. The book's ultimate purpose is to provide a fundamental understanding regarding the pilot plant & scale-up techniques, technology transfer, regulatory requirements and quality management systems & tools. The objective is to educate pharmaceutical students about basic concepts of scaling up the variety of pharmaceutical products as well as the regulatory requirements for drug approval.
This book follows the approved syllabus prescribed by Pharmacy Council of India, New Delhi. We designed the work to be a teaching resource for undergraduate, graduate students as well as experienced and novice industrial pharmaceutical scientists. Each chapter begins with a premise to familiarize the reader with the topic. A few salient features of this book are enriched artworks, flow charts, tables, mind maps. The mind maps help to communicate numerous complicated ideas in a clear and easy-to-grasp way. The presentation of content is very systematic as it uses different headings and subheadings in a hierarchical manner.
This book will be useful not only to the pharmaceutical scientists for developing the pharmaceutical dosage form but also to the formulation scientists and regulatory affairs department in finding the most efficient way of product registration around the globe.
Content
1. PILOT PLANT SCALE UP TECHNIQUES
2. TECHNOLOGY DEVELOPMENT AND TRANSFER
3. REGULATORY AFFAIRS
4. REGULATORY REQUIREMENTS FOR DRUG
APPROVAL
5. QUALITY MANAGEMENT SYSTEM AND TOOLS
6. INDIAN REGULATORY REQUIREMENTS
LIST OF ABBREVIATIONS
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