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About The Book
The Pharmacy Council of India has prescribed Industrial Pharmacy I [BP 502 T] and Industrial Pharmacy II [BP 702 T] courses in its B.Pharm syllabus. Industrial Pharmacy II course is designed to impart fundamental knowledge on pharmaceutical product development and its translation from laboratory to market. Upon completion of the course, the student shall be able to: (i) know the process of pilot plant and scale up of pharmaceutical dosage forms, (ii) understand the process of technology transfer from laboratory scale to commercial batch, (iii) know different Laws and Acts that regulate pharmaceutical industry, and (iv) understand the approval process and regulatory requirements for drug products.
Industrial Pharmacy discipline essentially relates to different functions in pharmaceutical industry; aiming ultimately at complete automation in presenting superior quality drug delivery systems meeting global standards.
This book is an attempt to present the desired information in up-to-date, concise and simple language. The course comprises five units, UNIT-I deals with Pilot plant scale up techniques, UNIT-II discusses Technology development and transfer, UNIT-III enlightens about Regulatory affairs and Regulatory requirements for drug approval, UNIT-IV consists of Quality management, and UNIT-V encompasses Indian Regulatory Requirements.
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Content
1. PILOT PLANT SCALE-UP TECHNIQUES
2. TECHNOLOGY DEVELOPMENT AND TRANSFER
3. REGULATORY AFFAIRS
4. QUALITY MANAGEMENT SYSTEMS
5. INDIAN REGULATORY REQUIREMENTS
ABBREVIATIONS
REVISION QUESTIONS
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