Industrial Pharmacy – Theory detailed Syllabus Scheme for Bachelor of Pharmacy (B.Pharm), 2019 regulation has been taken from the University of Mumbai official website and presented for the Pharmacy students. For Course Code, Subject Name, Continuous Mode, SE Marks, SE Duration, Total, Marks, Duration in Hours, Total Marks, and other information, do visit full semester subjects post given below.
For all other Mumbai University B.Pharm 7th Sem Syllabus 2019 Pattern, do visit B.Pharm 7th Sem 2019 Pattern Scheme. The detailed syllabus scheme for industrial pharmacy – theory is as follows.
BP702T: Industrial Pharmacy – Theory Syllabus for B.Pharm 7th Sem 2019 Pattern Mumbai University
Scope:
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Objectives
Upon completion of the course, the student shall be able to:
- Know the process of pilot plant and scale up of pharmaceutical dosage forms
- Understand the process of technology transfer from lab scale to commercial batch
- Know different Laws and Acts that regulate pharmaceutical industry
- Understand the approval process and regulatory requirements for drug products
UNIT -I 10
Pilot plant scale up techniques: General considerations – including significance ofpersonnel requirements, space requirements, raw materials, Pilot plant scale up considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC guidelines, Introduction to Platform technology
UNIT -II 10
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UNIT -III 10
- Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatoryauthorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals 2
- Regulatory requirements for drug approval: Drug Development Teams, Non-ClinicalDrug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigators Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
UNIT -IV 8
Quality management systems: Quality management & Certifications: Concept ofQuality, Total Quality Management, Quality by design, Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
UNIT -V 7
For the complete Syllabus, results, class timetable, and many other features kindly download the iStudy App
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Recommended Books: (Latest Editions)
- Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available at http,//en.wikipedia.org/wiki/Regulatory_ Affairs.
- International Regulatory Affairs Updates, 2005 available at http://www.iraup.com/about.php
- Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide for Prescription Drugs, Medical Devices, and Biologics Second Edition.
- Regulatory Affairs brought by learning plus, inc. available at http.//www.cgmp.com/ra.htm.
For detail syllabus of all other subjects of Bachelor of Pharmacy (B.Pharm), 2019 regulation do visit B.Pharm 7th Sem Subjects syllabus for 2019 regulation.