Regulatory Requirements in Pharmaceutical Industries detailed syllabus for Biomedical Engineering (Biomedical) for 2019 regulation curriculum has been taken from the Anna Universities official website and presented for the Biomedical students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Biomedical Engineering 7th Sem scheme and its subjects, do visit Biomedical 7th Sem 2019 regulation scheme. For Open Elective-II scheme and its subjects refer to Biomedical Open Elective-II syllabus scheme. The detailed syllabus of regulatory requirements in pharmaceutical industries is as follows.
Course Objective:
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Unit I
Regulatory Concepts
Quality assurance – Quality control – Practice of cGMP – Schedule M – USFDA.
Unit II
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Unit III
Intellectual Property Rights
Patent system – Different types of patents – Filing process of application for patent – Infringement of patents – The patent rules 2003 as amended by the patents (amendment) rules 2016.
Unit IV
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Unit V
Quality Audit and Self Inspections
SOPs – Documentation – Loan license auditing – Common technical documentation (CTD) – Drug master file (DMF).
Course Outcome:
For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier..
Text Books:
- C.V.SSubbrahmanyam&J.Thimmasetty, Pharmaceutical regulatory affairs, 1stEdn., vallabhPrakashan, New Delhi, 2012.
- Willig, H., Tuckeman, M.M. and Hitchings, W.S., Good Manufacturing Practices for Pharmaceuticals, 5th Edition, Marcel Dekker Drugs and the Pharmaceutical Sciences, by CRC Press, New York, 2000.
- N Udupa, Krishnamurthy Bhat, A Concise Textbook of Drug Regulatory Affairs, Manipal University Press (MUP); First Edition, 2015.
References:
- Ira R. Berry,The Pharmaceutical Regulatory Process, marcel dekker Series: Drugs and the Pharmaceutical Sciences, by CRC Press, Newyork, 2004.
- Mindy J. Allport-Settle, Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference, Pharmalogika Inc., USA, 2009.
- Sharma, P.P., How to Practice GMPs, 3rd Edition, Vandana Publications, 2006.
For detailed syllabus of all the other subjects of Biomedical Engineering 7th Sem, visit Biomedical 7th Sem subject syllabuses for 2019 regulation.
For all Biomedical Engineering results, visit Anna University Biomedical all semester results direct link.