Curriculum | Industrial Pharmacy-II(Theory) | B. Pharmacy

Course: B. Pharmacy VIIth Semester/ 4thYear
Name of Subject: Industrial Pharmacy-II(Theory)
Subject Code:  BP 702 T

 

Sr. No. Contents of the Topics Learning objectives Teaching Guidelines Methodology Time

(Hrs)

1 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 At the end of the lecture student should be able to understand and explain pilot plant scale up techniques Concept of scale up techniques including personnel requirements, space requirements,SUPAC guidelines,introduction to platform technology Didactic

PowerPoint Demonstration

Industry Visit

Lab Practicals

10
2 Technology development and transfer: WHO guidelines for Technology Transfer: Terminologies, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packing 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), TOT agencies in India – APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; Technology of Transfer (TOT) related documentation – confidentiality agreements, licensing, MoUs, legal issues. At the end of the lecture student should be able to understand and explain technology development and tranfer WHO guidelines, quality  risk management, Transfer from R & D to production, Granularity of TT Process, Documentation, Premises and equipments, qualification and validation, quality control, analytical method transfer, Approved regulatory bodies and agencies, Commercialization – practical aspects and problems Didactic

PowerPoint Demonstration

Industry Visit

Lab Practicals

10
3 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 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.

At the end of the lecture student should be able to understand and explain different aspects of regulatory affairs Concepts of regulatory affairs, , Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals, non clinical drug developments, Data Presentation for FDA Submissions, IND application Didactic

PowerPoint Demonstration

Industry Visit

Lab Practicals

10
4 Quality management systems: Quality management & Certifications: Concept of Quality, 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 At the end of the lecture student should be able to understand and explain quality management systems and certifications Study of Quality management systems ,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 Didactic

PowerPoint Demonstration

Industry Visit

Lab Practicals

08
5 Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Common Technical Document (CTD), Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs. At the end of the lecture student should be able to understand and explain Indian regulatory requirements Concept of Indian  regulatory requirements, CDSCO and state   licensing authority, CTD, COPP Regulatory requirements and approval procedures for New Drugs. Didactic

PowerPoint Demonstration

Industry Visit

Lab Practical’s

07
Admission 2017