Industrial Pharmacy-II

Teacher

Dr. Nikunja Basini Pati

Category

Core Courses

Course Attendees

Still no participant

Course Reviews

Still no reviews

Course Name : Industrial Pharmacy-II

Code(Credit) : BPHT4102(4-0-0)

Course Objectives

To impart fundamental knowledge on pharmaceutical product development and translation from laboratory to market

Learning Outcomes

  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.

Session Plan

Session 1

Pilot plant scale up techniques: Introduction

Session 2

General considerations - including significance of personnel requirements, space requirements, raw materials

General considerations - including significance of personnel requirements, space requirements, raw materials

Session 3

Pilot plant scale up considerations for solids

Session 4

Pilot plant scale up considerations for liquid orals

Session 5

Pilot plant scale up considerations for semi solids

Session 6

SUPAC guidelines

Session 7

Introduction to platform technology

Session 8

Technology development and transfer

Session 9

WHO guidelines for Technology Transfer(TT)

Session 10

Terminology, Technology transfer protocol

Session 11

Quality risk management

Session 12

Transfer from R & D to production (Process, packaging and cleaning)

Session 13

Granularity of TT Process (API, excipients, finished products, packaging materials), Documentation, Premises and equipments, qualification and validation, quality control

Session 15

Approved regulatory bodies and agencies

Session 16

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

Session 17

Regulatory affairs: Introduction, Historical overview of Regulatory Affairs

Session 18

Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals

Session 19

Regulatory requirements for drug approval: Drug Development Teams

Session 20

Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology

Session 21

General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA),

Session 22

Clinical research / BE studies, Clinical Research Protocols, Data Presentation for FDA Submissions

Session 23

Management of Clinical Studies

Session 24

Biostatistics in Pharmaceutical Product Development

Session 25

Quality management systems: Quality management & Certifications: Concept of Quality

Session 27

Quality by Design (QbD)

Session 29

Out of Specifications (OOS)

Session 30

Change control

Case Studies

Case Studies

Recent Comments

    Our Main Teachers