1.2.3 Pilot-Plant Operations

A pilot-plant operation includes series of operational aspects. These are as follows:

1. Validation includes the following of all utility systems, process equipments, control

systems so that pilot-plant can be fully validated and ensure compliance with CGMP

i. DQ (Design Qualification)

ii. IQ (Installation Qualification)

iii. OQ (Operational Qualification)

iv. PQ (Performance Qualification)

2. Training should be given in four areas

i. Compliance with CGMP and other quality systems

ii. Environmental and safety responsibilities

iii. Compliance with SOPs

iv. Technical knowledge and skills

3. Engineering support is required for

i. Design, commissioning, and validation of pilot-plant facility

ii. Co-ordination, direction and scheduling of ongoing operations at the pilotplant facility

4. Maintenance is required

i. To compliance with CGMP norms

ii. To ensure integrity of data and reliability of equipment

5. Calibration of equipment/instrument is required

i. To compliance with CGMP norms

ii. To ensure the integrity of data generated during the development process

6. Material control with computer-based system

7. Inventory should be maintained by computer-based inventory system

8. Orders should be placed through computer-based system and first-in first-out

criteria is followed.

9. Labelling should be done in compliance with regulatory guidelines

10. Process and manufacturing activities includes

i. Formulation and process development

ii. Clinical supply manufacture

iii. Technology evaluation, scale and transfer

11. QA and QC activities

QA activity involves

i. Auditing pilot-plant, component suppliers.

ii. Reviewing validation and engineering documentation

iii. Reviewing, approving and maintaining batch records for clinical supplies

iv. Sampling and release of raw materials and clinical supplies

v. Maintaining and approval of SOPs

Introduction to Pilot-Plant and Scale-up 5

QC activities include

i. Releasing and testing (physical, chemical and microbiological testing) of

finished products.

ii. Testing for validation as well as revalidation programs.

iii. QC in-process testing during each stage (drug development, pilot-plant, scaleup and technology transfer)

 

Pilot-Plant Scale-up Techniques

2 Industrial Pharmacy II

The pharmaceutical industry is growing with high speed in the last few years. New

drugs, as well as generic drugs, have been coming in the market. Research and development sector is also growing with good growth rate. Researchers are encouraged to

use the latest processes and technologies. In short, Cona, the pharmaceutical industry,

has witnessed significant innovations and inventions coming day by day. A huge sum

of money is invested in the pharmaceutical production to this much loss unit. According to a recent study, developing a new prescription medicine which gains market

approval is estimated to cost drug makers nearly $2 billion. One cannot afford loss

after setting up a commercial production unit.

So to avoid this loss, a replica of the main design has been set up but at a smallscale. This is known as pilot-plant and the data obtained from this pilot-plant is used

in establishing a commercial plant is known as scale-up. If we go with the dictionary

meaning then the pilot-plant is a “small factory that is built as a model to test systems

and processes before building other similar factories” and scale-up is “to increase the

size, amount, or importance of something, usually an organization or process.” In the

pharmaceutical industry pilot-plant scale-up techniques have different considerations

for different dosage forms.

1.1 PLANT

A plant can be defined as a place where 5Ms like money, material, method, man and

machines are brought together for the manufacturing of products. A plant contains all

assets of business like land, money, equipment, employees, etc. In the pharmaceutical

industry a plant is used as a synonym for manufacturing plant where drug/medical

devices/cosmetics manufacturing is going on. Various guidelines by regulatory authorities have to be followed by the manufacturer before setting up a manufacturing

plant in the pharmaceutical industry. There are several types of manufacturing plants

in the pharma industry like API manufacturing plant, formulation manufacturing plant,

contract manufacturing plant, etc.

1.2 PILOT-PLANT

There is a saying that “commits your blunders on a small-scale and make up your

profits on a large-scale.”

2

Introduction to Pilot-Plant and

Scale-up

1

 

Pilot-Plant Scale-up Techniques

2 Industrial Pharmacy II

The pharmaceutical industry is growing with high speed in the last few years. New

drugs, as well as generic drugs, have been coming in the market. Research and development sector is also growing with good growth rate. Researchers are encouraged to

use the latest processes and technologies. In short, Cona, the pharmaceutical industry,

has witnessed significant innovations and inventions coming day by day. A huge sum

of money is invested in the pharmaceutical production to this much loss unit. According to a recent study, developing a new prescription medicine which gains market

approval is estimated to cost drug makers nearly $2 billion. One cannot afford loss

after setting up a commercial production unit.

So to avoid this loss, a replica of the main design has been set up but at a smallscale. This is known as pilot-plant and the data obtained from this pilot-plant is used

in establishing a commercial plant is known as scale-up. If we go with the dictionary

meaning then the pilot-plant is a “small factory that is built as a model to test systems

and processes before building other similar factories” and scale-up is “to increase the

size, amount, or importance of something, usually an organization or process.” In the

pharmaceutical industry pilot-plant scale-up techniques have different considerations

for different dosage forms.

1.1 PLANT

A plant can be defined as a place where 5Ms like money, material, method, man and

machines are brought together for the manufacturing of products. A plant contains all

assets of business like land, money, equipment, employees, etc. In the pharmaceutical

industry a plant is used as a synonym for manufacturing plant where drug/medical

devices/cosmetics manufacturing is going on. Various guidelines by regulatory authorities have to be followed by the manufacturer before setting up a manufacturing

plant in the pharmaceutical industry. There are several types of manufacturing plants

in the pharma industry like API manufacturing plant, formulation manufacturing plant,

contract manufacturing plant, etc.

1.2 PILOT-PLANT

There is a saying that “commits your blunders on a small-scale and make up your

profits on a large-scale.”

2

Introduction to Pilot-Plant and

Scale-up

1

 

12.4.1 NABL Vision 187

12.4.2 NABL Mission 187

12.4.3 Achievements of NABL (As per the Official Website of NABL) 188

12.4.4 Scope of NABL Accreditation 188

12.4.5 Benefits of Accreditation 189

Long Answer Type Questions 190

Short Answer Type Questions 190

Objective Type Questions 190

Summary 193

xvi Industrial Pharmacy II

UNIT 5: Indian Regulatory Requirements

13. Central and State Drug Regulatory Authority of India 206

13.1 Drug Regulatory Authority 206

13.2 Central Drug Standard Control Organisation (CDSCO) 208

13.3 State Licensing Authorities (SLA) 212

Long Answer Type Questions 213

Short Answer Type Questions 213

Objective Type Questions 213

14. CTD and New Drug Approval Process in India 215

14.1 Common Technical Document 215

14.2 Certificate of Pharmaceutical Product (COPP) 217

14.3 New Drug Approval in India 218

Requirements for New Drug Approval 220

Long Answer Type Questions 221

Short Answer Type Questions 221

Objective Type Questions 222

Summary 224

Index 229

1. Introduction to Pilot-Plant and Scale-up

2. General Considerations and Pilot-Plant Considerations

for Different Dosage Forms

3. SUPAC Guidelines and Platform Technology

Summary

1

 

2.5 Documentation 21

Long Answer Type Questions 23

Short Answer Type Questions 23

Objective Type Questions 23

UNIT 1: Pilot-Plant Scale-up Techniques

xii Industrial Pharmacy II

3. SUPAC Guidelines and Platform Technology 25

3.1 Purpose of Guidance 25

3.2 Evolution of SUPAC Guidance 25

3.3 Terminologies used in Guidance Document 26

3.4 Level of Changes 28

3.5 Type of Changes 28

3.6 Introduction to Platform Technology 37

Long Answer Type Questions 39

Short Answer Type Questions 39

Objective Type Questions 39

Summary 41

UNIT 2: Technology Development and Transfer

4. Technology Development and Transfer 50

4.1 Technology 50

4.2 Technology Development 50

4.3 Technology Transfer 50

4.4 Technology Transfer in Pharmaceutical Sciences 51

4.4.1 Reasons for Technology Transfer 54

4.4.2 Types of Technology Transfer 55

4.4.3 Methods of Technology Transfer 56

Long Answer Type Questions 57

Short Answer Type Questions 57

Objective Type Questions 57

5. WHO Guidelines for Transfer of Technology 60

5.1 Introduction 60

5.2 Transfer of Technology (TOT) as per WHO 60

5.3 Scope of WHO Guidelines for TOT 62

5.4 Terminologies Source 62

5.5 Organisation and Management 66

5.6 Quality Risk Management 68

5.7 QRM Application in Pharmaceuticals 72

5.8 Transfer from R&D to Production (Process, Packaging and Cleaning)

and Granularity of TT Process (API, Excipients, Finished Products,

Packaging Material) 74

5.9 Analytical Method Transfer 79

5.10 Premises and Equipment 81

5.11 Documentation 84

5.12 Qualification and Validation 84

Long Answer Type Questions 85

Short Answer Type Questions 85

Objective Type Questions 85

Contents xiii

6. Regulation of Transfer of Technology 87

6.1 Authorities and Agencies Involved in TOT 87

6.2 Problems Faced During Commercialisation 89

6.3 Case Studies of Technology Transfer 90

6.4 TOT Agencies in India 91

6.4.1 APCTT 91

6.4.2 NRDC 93

 

6.4.3 TIFAC (Technology Information Forecasting and

Assessment Council) 95

6.4.4 BCIL (Biotech Consortium India Limited) 97

6.4.5 TBSE (Technology Bureau for Small Enterprises)/SIDBI

(Small Industries Development Bank of India) 98

6.5 TOT Related Documentation 99

6.5.1 Confidentiality Agreements 99

6.5.2 Licensing 100

6.5.3 MoU 102

6.5.4 Legal Issues 103

Long Answer Type Questions 104

Short Answer Type Questions 104

Objective Type Questions 104

Summary 107

UNIT 3: Regulatory Affairs and Regulatory Requirements for Drug Approval

7. Regulatory Affairs and its Role 114

7.1 Introduction 114

7.2 Historical Overview of Regulatory Affairs 115

7.3 Regulatory Authorities 116

7.4 Role of Regulatory Affairs Department 117

7.5 Responsibility of Regulatory Affairs Professionals 119

Long Answer Type Questions 120

Short Answer Type Questions 120

Objective Type Questions 120

8. Drug Development and Non-Clinical Studies 122

8.1 Drug Development Teams 122

8.2 Non-clinical Drug Development 124

8.3 Toxicology 126

8.4 Drug Metabolism 126

Long Answer Type Questions 128

Short Answer Type Questions 128

Objective Type Questions 128

xiv Industrial Pharmacy II

9. INDA and NDA 130

9.1 General Considerations of Investigational New Drug (IND)

Application 130

9.2 Investigator’s Brochure (IB) 131

9.3 New Drug Application (NDA) 132

9.4 Clinical Research/BE (Bioequivalence) Studies 134

9.5 Biostatistics in Pharmaceutical Product Development 136

9.6 Data Presentation for FDA Submissions 138

9.7 Management of Clinical Studies 139

Long Answer Type Questions 139

Short Answer Type Questions 140

Objective Type Questions 140

Summary 142

UNIT 4: Quality Management Systems

10. Quality and Related Concepts 150

10.1 Concept of Quality 150

10.2 Quality Control 155

10.3 Quality Assurance 156

10.4 Comparison Between Quality Control and Quality Assurance 156

Long Answer Type Questions 157

Short Answer Type Questions 157

Objective Type Questions 157

11. Total Quality Management and Other Quality Management

Systems 159

11.1 Total Quality Management (TQM) 159

11.1.1 Origin of TQM 159

11.1.2 Characteristics of TQM 159

11.1.3 Principles of TQM 160

11.1.4 Key Elements of TQM 160

11.1.5 Main Objective of TQM: Continuous Improvement 161

11.1.6 Importance of TQM in the Pharmaceutical Industry 163

 

FDA submissions, management of clinical studies.

UNIT 4 08 Hours

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 5 07 Hours

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.

Contents

Preface vii

1. Introduction to Pilot-Plant and Scale-up 2

1.1 Plant 2

1.2 Pilot-Plant 2

1.2.1 Reasons for Conducting Pilot-Plant Studies 3

1.2.2 Objectives of Pilot-Plant 3

1.2.3 Pilot-Plant Operations 4

1.3 Scale-up 5

1.3.1 Need of Scale-up 5

1.3.2 Steps in Scale-up 5

1.3.3 Objectives of Scale-up 6

1.3.4 Relation between Pilot-Plant and Scale-up 6

Long Answer Type Questions 7

Short Answer Type Questions 7

Objective Type Questions 7

2. General Considerations and Pilot-Plant Considerations for

Different Dosage Forms 9

2.1 General Considerations 9

2.1.1 Reporting Responsibilities 9

2.1.2 Personnel Requirement 9

2.1.3 Space Requirements 10

2.1.4 Review of the Formula 11

2.1.5 Raw Materials 11

2.1.6 Equipment 11

2.1.7 Production Rate 11

2.1.8 Process Evaluation 11

2.1.9 Preparation of Master Manufacturing Procedures 12

2.1.10 Product Stability and Uniformity 13

2.1.11 Good Manufacturing Practices (GMP) Considerations 13

2.1.12 Transfer of Analytical Methods to Quality Assurance 13

2.2 Pilot-Plant Scale-up Considerations for Solids (Tablets) 13

2.3 Pilot-Plant Scale-up Considerations for Oral Liquids 18

2.4 Pilot-Plant Scale-up Considerations for Semisolids 20

 

FDA submissions, management of clinical studies.

UNIT 4 08 Hours

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 5 07 Hours

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.

Contents

Preface vii

1. Introduction to Pilot-Plant and Scale-up 2

1.1 Plant 2

1.2 Pilot-Plant 2

1.2.1 Reasons for Conducting Pilot-Plant Studies 3

1.2.2 Objectives of Pilot-Plant 3

1.2.3 Pilot-Plant Operations 4

1.3 Scale-up 5

1.3.1 Need of Scale-up 5

1.3.2 Steps in Scale-up 5

1.3.3 Objectives of Scale-up 6

1.3.4 Relation between Pilot-Plant and Scale-up 6

Long Answer Type Questions 7

Short Answer Type Questions 7

Objective Type Questions 7

2. General Considerations and Pilot-Plant Considerations for

Different Dosage Forms 9

2.1 General Considerations 9

2.1.1 Reporting Responsibilities 9

2.1.2 Personnel Requirement 9

2.1.3 Space Requirements 10

2.1.4 Review of the Formula 11

2.1.5 Raw Materials 11

2.1.6 Equipment 11

2.1.7 Production Rate 11

2.1.8 Process Evaluation 11

2.1.9 Preparation of Master Manufacturing Procedures 12

2.1.10 Product Stability and Uniformity 13

2.1.11 Good Manufacturing Practices (GMP) Considerations 13

2.1.12 Transfer of Analytical Methods to Quality Assurance 13

2.2 Pilot-Plant Scale-up Considerations for Solids (Tablets) 13

2.3 Pilot-Plant Scale-up Considerations for Oral Liquids 18

2.4 Pilot-Plant Scale-up Considerations for Semisolids 20

 

Special thanks and gratitude to my mother Smt Premwati Ghangas for being the

one who supports me, inspires me and loves me. I am grateful to my uncle Advocate

Sh. Rajbir Ghangas for inspiring me. I extend my sincere word of thanks to Sujata

Anand, Shobhit Anand, Pooja Anand and Aashish Ghangas who have always been a

constant support. Last but not the least, I express profound love to sweet children of

my family Shorya, Surya and Shakti who always act as stress reliever for me with

their innocent smile.

I have learned a lot from my students, and they deserve an equal credit for the

insights that helped create this book. I hope students will appreciate this book.

Jyoti Ghangas

Acknowledgements

Syllabus Prescribed by Pharmacy Council of India

for Bachelor of Pharmacy Course

BP 702 T. INDUSTRIAL PHARMACY II (Theory)

45 Hours

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 1 10 Hours

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 2 10 Hours

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 3 10 Hours

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

 

t is a moment of great pleasure and immense satisfaction for me to express deep

 gratitude and gratefulness to my father Er VK Agarwal and my mother Smt Asha

Agarwal for inspiring me to bring out this book.

I am especially thankful to Shri RP Singal Ji, Chairman, RP Educational Trust, for

his all time support and encouragement. My special thanks to Er Bharat Singal, and

Anuj Singal, Secretary, RP Educational Trust, for inspiring me to bring out this book.

I am indebted to Shri DL Mittal, Director, RPIIT Technical and Medical Campus, for

his motivation.

I am also thankful to CBS Publishers and Distributors. I would like to put on record

the sincere efforts of Mr YN Arjuna (Senior Vice President Publishing, Editorial and Publicity)

and his team comprising of Ms Ritu Chawla (GM Production), Mr Parmod Kumar

(DTP Operator) and Mr Rohan Prasad (Graphic Designer), for bringing out the book

in the present form.

My completion of this project could not have been accomplished without the support

of my loving daughter Shreya and son Vaidish who have allowed me time away from

the writing and research work.

Last but not the least, I express my love to my wife Dr Shilpi for her caring, motivating

and supportive nature. Her encouragement was always there when the times got rough.

It was a great comfort and relief that she kept me away from our household activities

during the entire tenure of writing and research work.

To my numerous students, whom I cannot possibly name individually, I thanks for

their class interactions which have been the guiding spirit in selection of the subject

matter and its logical arrangement.

Gaurav Agarwal

Acknowledgements

I

 

Industrial

Pharmacy II

Gaurav Agarwal

MPharm (BITS–Pilani) PhD

Dean, Faculty of Pharmacy

RP Inderaprastha Institute of Technology

Karnal, Haryana

Jyoti Ghangas

MPharm (Amity University, Noida)

Assistant Professor, Faculty of Pharmacy

RP Inderaprastha Institute of Technology

Karnal, Haryana

CBS Publishers & Distributors Pvt Ltd

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Bhopal • Bhubaneswar • Hyderabad • Jharkhand • Nagpur • Patna • Pune

Uttarakhand • Dhaka (Bangladesh) • Kathmandu (Nepal)

As per the latest syllabus prescribed by

Pharmacy Council of India

for Bachelor of Pharmacy Course

Disclaimer

Science and technology are constantly changing fields. New research and experience broaden the scope of

information and knowledge. The authors have tried their best in giving information available to them while

preparing the material for this book. Although, all efforts have been made to ensure optimum accuracy of the

material, yet it is quite possible some errors might have been left uncorrected. The publisher, the printer and

the authors will not be held responsible for any inadvertent errors, omissions or inaccuracies.

eISBN: xxxx

Copyright © Authors and Publisher

First eBook Edition: 2020

All rights reserved. No part of this eBook may be reproduced or transmitted in any form or by any means,

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Preface

T he book Industrial Pharmacy II is designed specifically as per PCI (Pharmacy

Council of India) B Pharmacy Seventh Semester students. The book covers the

entire syllabus prescribed by PCI Course Regulation, 2014 in a very simple and precise

manner to meet the demanding needs of the pharmacy aspirants. This book covers

wide areas and contains a comprehensive description of current existing knowledge

of drug regulatory affairs. The text not only deals with the basic concepts but also

emphasizes technical and practical aspects of the subject. The book is primarily intended

as a textbook for students of pharmacy for degree and masters courses in drug

regulatory affairs. The book is also of great help for technocrats who want to pursue

career in regulatory affairs department in pharmaceutical industry. Being an

interdisciplinary subject, it is today covering a wide range of interest among the

students, teaching and industry people. Taking this increasing interest into account,

this book gives a comprehensive introduction to the subject.

The book contains numerous specimens, vivid illustrations, tables, diagrams and

flow diagrams to present the ideas. The distinguishing feature is a summary of all the

units at the end of each unit. The structure and the content of the book have changed

to reflect modern thinking and current university curricula throughout the world. In

spite of great care there might be some mistakes and deficiencies. We will be grateful

for giving suggestions to improve. So go through the content and do mail to me at

gbitsian@rediffmail.com.

Gaurav Agarwal

Jyoti Ghangas

I

 

Preface

T he book Industrial Pharmacy II is designed specifically as per PCI (Pharmacy

Council of India) B Pharmacy Seventh Semester students. The book covers the

entire syllabus prescribed by PCI Course Regulation, 2014 in a very simple and precise

manner to meet the demanding needs of the pharmacy aspirants. This book covers

wide areas and contains a comprehensive description of current existing knowledge

of drug regulatory affairs. The text not only deals with the basic concepts but also

emphasizes technical and practical aspects of the subject. The book is primarily intended

as a textbook for students of pharmacy for degree and masters courses in drug

regulatory affairs. The book is also of great help for technocrats who want to pursue

career in regulatory affairs department in pharmaceutical industry. Being an

interdisciplinary subject, it is today covering a wide range of interest among the

students, teaching and industry people. Taking this increasing interest into account,

this book gives a comprehensive introduction to the subject.

The book contains numerous specimens, vivid illustrations, tables, diagrams and

flow diagrams to present the ideas. The distinguishing feature is a summary of all the

units at the end of each unit. The structure and the content of the book have changed

to reflect modern thinking and current university curricula throughout the world. In

spite of great care there might be some mistakes and deficiencies. We will be grateful

for giving suggestions to improve. So go through the content and do mail to me at

gbitsian@rediffmail.com.

Gaurav Agarwal

Jyoti Ghangas

I

 

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Patna

to

my father

Sh. Ram Kumar Ghangas

—Jyoti Ghangas