INDUSTRIAL PHARMACYII (Theory)-BPHT 4102(4-0-0)

Teacher

Dr.Gnyana Ranjan Parida

Category

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Course Name : Industrial Pharmacy-II

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

Course Objectives 

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

Course  Outcomes :

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 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 1

Pilot plant scale up techniques: Introduction

1.chapter-1

Session 2

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

2. General Consideration

Session 3

Pilot plant scale up considerations for solids

3. Pilot Plant- Tablet

Session 4

Pilot plant scale up considerations for solids-Capsule

4.pilot plant capsule

Session 5

Pilot plant scale up considerations for liquid orals

5. Pilot plant liquid dosage form

Session 6

Pilot plant scale up considerations for semi solids

6.PILOT PlaNT FOR SEmi solid

Session 7

SUPAC guidelines

7.SUPAC GUIDELINE

Session 8

Introduction to platform technology

8.PLATFORM TECHNOLOGY

Session 9

Technology development and transfer:WHO guidelines for Technology Transfer(TT)

1.WHO Guidelines and Terminologies

Session 10

Terminology

Terminologies

Session 11

Technology transfer protocol

TT Protocol

Session 12

Quality risk management

QRM

Session 13

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

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

Session 14

Granularity of TT Process

3.Granularity of TT Process& Documentation

Session 15

Qualification and validation

4. qualification nd validation

Session 16

Quality control, Analytical method transfer

Quality control, Analytical method transfer

Session 17

Approved regulatory bodies and agencies

5.TT-Agencies and Approved bodies

Session 18

Commercialization- practical aspects and problems (case studies)

6.Commercialisation

Session 19

TT agencies in India- APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI

7.TT agencies

Session 20

TT related documentation- confidentiality agreement, licensing, MoUs, legal issues

8.TT documentation with legal issues

Session 21

Regulatory affairs: Introduction, Historical overview of Regulatory Affairs

History of RA

Session 22

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

Role of Regulatory affairs department

Session 23

Regulatory requirements for drug approval: Drug Development Team

REGULATORY REQUIREMENTS FOR DA- UNIT 3

Session 24

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

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

Session 25

General considerations of Investigational New Drug (IND) Application

IND

Session 26

Investigator’s Brochure (IB)

IB-Investigator's broucher

Session 27

New Drug Application (NDA)

NDA

Session 28

Clinical research / BE studies, Clinical Research Protocols

Clinical research BE studies, Clinical Research Protocols

Session 29

Data Presentation for FDA Submissions

Data Presentation for FDA SubmissionsData Presentation for FDA Submissions

Session 30

Management of Clinical Studies

Management of Clinical Studies

Session 31

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

Quality management systems

Session 32

Total Quality Management

TQM

Session 33

Quality by Design (QbD)

QbD

Session 34

Six Sigma concept

SIX SIGMA

Session 35

Out of Specifications (OOS) & change control

OOS+CC

Session 36

Introduction to ISO 9000 series of quality systems standards, ISO 14000

ISO

Session 37

NABL

NABL

Session 38

GLP

GLP-CONCEPT

Session 39

Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO)

CDSCO

Session 40

State Licensing Authority: Organization, Responsibilities

State Licensing Authority Organization, Responsibilities

Session 41

Certificate of Pharmaceutical Product (COPP)

COPP

Session 42

Regulatory requirements and approval procedures for New Drugs.

Regulatory requirements and approval procedures for New Drugs.

Session 43

Regulatory requirements and approval procedures for New Drugs.

Regulatory requirements and approval procedures for New Drugs.

Session 44

Regulatory requirements and approval procedures for New Drugs.

Regulatory requirements and approval procedures for New Drugs.

Session 45

Regulatory requirements and approval procedures for New Drugs.

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.

Our Main Teachers

I am Dr.Gnyana Ranjan Parida , working as an Assistant Professor in the Department of Pharmaceutics, School of Pharmacy and Life Sciences, Centurion University of Technology and Management. I have completed my Bachelor in Pharmacy From Biju Patnaik University of Technology. I did my Master in Pharmacy in Pharmaceutics Specialization from School of Pharmaceutical Education […]

I am ladi alik kumar working as an asst professor in schoole of  Pharmacy, Centurion University, rayagada campus. I am complete my M.Pharm at Gayatri institute of science and technology, Gunupur . Thenever i had worked as an Production asst at M/S Aurobindo Pharma , Vizag