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Industrial Pharmacy - 2 : The Regulatory Appraoch

J. Thimma Setty

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Rs. 315

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Binding: Paper Back

Publisher: Vallabh Prakashan

Language: English

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Description

The book ?Industrial Pharmacy?II' includes topics related to technology transfer (including pilot plant and scale up) and associated regulatory activities, national and international. Further, good industrial practices are described. Several topics of relevance and current interest with respect to the pharmaceutical industry are described in our earlier books (both are from Vallabh Prakashan, Delhi), (1) Pharmaceutical Production and Management and (2) Industrial Pharmacy ? Selected Topics. The book consists of 15 chapters, Pharmaceutical Pilot Plant, Scale Up Techniques ? Principles, Platform Technologies in Pharmaceutical Development, Technology Transfer and Development. Total Quality Management, ISO Series, QbD in Pharmaceutical Development, Pharmaceutical Quality System (ICH Q10), Investigation of OOS in Pharmaceutical Production, Regulatory Aspects of Change Control in Pharmaceuticals, Good Laboratory Practice ? Regulations, National Accreditation Board for Testing and Calibration Laboratories (NABL), Regulatory Requirements for Drug Approvals and Indian Regulatory Systems and Requirements. The reader-friendly format is maintained throughout the book. Every chapter starts with the objectives and ends with a summary. Attention is given to include the following:? 1. Conceptualization of principles with illustrations, on the lines of concept mapping. 2. Application of principles 3. Question bank for drawing the attention of relevant particulars. This is an authentic VALLABH PRAKASHAN book by Vallabh Originals.

Additional Info

Author	C. V. S. Subrahmanyam, J. Thimma Setty
Publisher	Vallabh Prakashan
Language	English
Binding Type	Paper Back
Main Category	Medical
ISBN13	9789385529504
SKU	BK 0177149