INDUSTRIAL PHARMACY II - B. Pharma 7th Semester PDF Notes

BP 702 T. INDUSTRIAL PHARMACY II (Theory)

Scope:This course is designed to impart fundamental knowledge on pharmaceutical product development and translation from laboratory to market

Objectives: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 Content:

UNIT-I

Pilot plant scale up techniques: General considerations - including significance  of personnel requirements, space requirements, raw materials, Pilot plant scale upconsiderations for Tablets, Pilot plant scale up considerations for Capsules, Pilot plant scale up considerations for liquid orals, Pilot plant scale up considerations for 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

WHO guidelines for Technology Transfer (TT):

UNIT-III

Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulator y 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

Quality Risk Management:

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.

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.