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This course is designed to impart fundamental knowledge on pharmaceutical product development and translation from laboratory to market
Upon completion of the course, the student shall be able to:
1. Know the process of pilot plant and scale up of pharmaceutical dosage forms.
2. Understand the process of technology transfer from lab scale to commercial batch
3. Know different Laws and Acts that regulate pharmaceutical industry
4. Understand the approval process and regulatory requirements for drug products
Course Syllabus
Module I:
Pilot plant scale up techniques: General considerations - including significance of personnel 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.
Module II:
Technology development and transfer: WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and equipments, qualification and validation, quality control, analytical method transfer, Approved regulatory bodies and agencies, Commercialization - practical aspects and problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs, legal issues.
Module III:
Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals.
Module IV:
Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s 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.
Module V:
Quality management systems: Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP.
Module VI:
Indian Regulatory Requirements: Central Drug Standard control Organizaion (CDSCO), State Lisencing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for new drugs.
General considerations - including significance of personnel requirements, space requirements, raw materials
Technology development and transfer:WHO guidelines for Technology Transfer(TT)
Transfer from R & D to production (Process, packaging and cleaning)
Transfer from R & D to production (Process, packaging and cleaning)
TT related documentation- confidentiality agreement, licensing, MoUs, legal issues
Regulatory affairs: Introduction, Historical overview of Regulatory Affairs
Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals
Regulatory requirements for drug approval: Drug Development Team
Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology
Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology
Clinical research / BE studies, Clinical Research Protocols
Data Presentation for FDA Submissions
Data Presentation for FDA SubmissionsData Presentation for FDA Submissions
Quality management systems: Quality management & Certifications: Concept of Quality
State Licensing Authority: Organization, Responsibilities
Regulatory requirements and approval procedures for New Drugs.
Regulatory requirements and approval procedures for New Drugs.
Regulatory requirements and approval procedures for New Drugs.
Regulatory requirements and approval procedures for New Drugs.
Regulatory requirements and approval procedures for New Drugs.
Regulatory requirements and approval procedures for New Drugs.
Regulatory requirements and approval procedures for New Drugs.
Regulatory requirements and approval procedures for New Drugs.
Recommended Books: (Latest Editions)
1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available at http,//en.wikipedia.org/wiki/Regulatory_ Affairs.
2. International Regulatory Affairs Updates, 2005. available at http://www.iraup.com/about.php
3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide for Prescription Drugs, Medical Devices, and Biologics’ Second Edition.
4. Regulatory Affairs brought by learning plus, inc. available at http.//www.cgmp.com/ra.htm.
I am Dr.Gnyana Ranjan Parida , working as an Assistant Professor in the Department of Pharmaceutics, School of Pharmacy and Life Sciences, Centurion University of Technology and Management. I have completed my Bachelor in Pharmacy From Biju Patnaik University of Technology. I did my Master in Pharmacy in Pharmaceutics Specialization from School of Pharmaceutical Education […]
I am ladi alik kumar working as an asst professor in schoole of Pharmacy, Centurion University, rayagada campus. I am complete my M.Pharm at Gayatri institute of science and technology, Gunupur . Thenever i had worked as an Production asst at M/S Aurobindo Pharma , Vizag