Regulatory Requirements in Pharmaceutical Industries Med Ele 7th Sem Syllabus for BE 2017 Regulation Anna Univ (Open Elective II) detail syllabus for Medical Electronics (Med Ele), 2017 regulation is collected from the Anna Univ official website and presented for students of Anna University. The details of the course are: course code (OPY752), Category (OE), Contact Periods/week (3), Teaching hours/week (3), Practical Hours/week (0). The total course credits are given in combined syllabus.
For all other med ele 7th sem syllabus for be 2017 regulation anna univ you can visit Med Ele 7th Sem syllabus for BE 2017 regulation Anna Univ Subjects. For all other Open Elective II subjects do refer to Open Elective II. The detail syllabus for regulatory requirements in pharmaceutical industries is as follows.
Course Objective:
- To acquire the knowledge of pharmaceutical industry regulations and research
Unit I
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Unit II
Regulatory Aspects
Pharmaceuticals: Bulk drug manufacture; Personnel, Buildings and Facilities, Process Equipment, Documentation and Records, Materials Management, Production and In-Process Controls, Packaging and Identification Labelling of APIs and Intermediates, Storage and distribution, – Biotechnology derived products; Principles, Personnel, Premises and equipments, Animal quarters and care, production, labelling, Lot processing records and distribution records, quality assurance and quality control.
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:
On completion of the course, the student will be able
- To be familiarise with the pharmaceutical industry manufacturing practices and regulatory aspects of pharmacy products.
- To know the process of patenting activities.
- To know the quality guidelines followed for pharmaceutical products and few of the aspects involved in document preparation for pharmaceutical product registration.
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 detail syllabus of all other subjects of BE Med Ele, 2017 regulation do visit Med Ele 7th Sem syllabus for 2017 Regulation.
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