Regulatory Requirements in Pharmaceutical Industries detail syllabus for Pharmacy (Pharma), 2017 regulation is taken from Anna University official website and presented for students of Anna University. The details of the course are: course code (PY8702), Category (PC), Contact Periods/week (3), Teaching hours/week (3), Practical Hours/week (0). The total course credits are given in combined syllabus.
For all other pharma 7th sem syllabus for b.tech 2017 regulation anna univ you can visit Pharma 7th Sem syllabus for B.Tech 2017 regulation Anna Univ Subjects. 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
For complete syllabus and results, class timetable and more pls download iStudy. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.
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
For complete syllabus and results, class timetable and more pls download iStudy. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.
Unit V
Quality Audit and Self Inspections
SOPs – Documentation – Loan license auditing – Common technical documentation (CTD) – Drug
master file (DMF).
Course Outcome:
- 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 and J.Thimmasetty, Pharmaceutical regulatory affairs, 1st Edn., 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 B.Tech Pharma, 2017 regulation do visit Pharma 7th Sem syllabus for 2017 Regulation.
Dont forget to download iStudy for latest syllabus and results, class timetable and more.