Industrial Pharmacy Ii Syllabus PDF | B.Pharm 7th Semester | Old Syllabus

Industrial Pharmacy Ii syllabus for 7th Semester. This page presents the detailed syllabus content from the original Old Syllabus PDF.

About This Syllabus

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

Course Syllabus

Unit-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

Unit-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

Unit-Iii 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.

Unit-Iv 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

Unit-V Indian Regulatory Requirements: Central Drug Standard Control

Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.

The original syllabus PDF is available below for students who want to download and refer to the complete document.