February 19, 2025

702T Industrial Pharmacy II Theory, Syllabus, Notes, PDF, Books Download

BP702T Industrial Pharmacy II Theory, Syllabus, Notes, PDF, Books Download

Industrial Pharmacy Theory

UNIT-I Pilot plant scale-up techniques

General considerations include 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 equipment, 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.


  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. Textbook 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.


Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise

Final Year B Pharm Sem VIIBP701T Instrumental Methods of Analysis Theory
BP702T Industrial Pharmacy TheoryBP703T Pharmacy Practice Theory
BP704T Novel Drug Delivery System TheoryBP705 P Instrumental Methods of Analysis Practical
Final Year B Pharm Sem VIIBP801T Biostatistics and Research Methodology Theory
BP802T Social and Preventive Pharmacy TheoryBP803ET Pharmaceutical Marketing Theory
BP804ET Pharmaceutical Regulatory Science TheoryBP805ET Pharmacovigilance Theory
BP806ET Quality Control and Standardization of Herbals TheoryBP807ET Computer-Aided Drug Design Theory
BP808ET Cell and Molecular Biology TheoryBP809ET Cosmetic Science Theory
BP810ET Experimental Pharmacology TheoryBP811ET Advanced Instrumentation Techniques Theory
BP812ET Dietary supplements and NutraceuticalsPharmaceutical Product Development

Suggested readings

Pharmaceutics I Practical * Pathophysiology