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About The Book
It is primarily intended to cater the needs of post graduate students of pharmacy of all specializations. These topics bring awareness at B. Pharmacy level and personnel working in the pharmaceutical industry. Pharmaceutical Regulatory Affairs comprises of laws, acts and regulations governing the pharmaceutical industry.
The subject matter is arranged in several chapters and headings, so as to clarify the concepts. The book comprises 8 chapters—Intellectual Property Rights (IPR), Patents in India, Organizations and Agreements-IPR, ISO, Total Quality Management (TQM), Stability Guidelines–ICH and WHO, Generic Drug Products and Documentation and Records (in GMP).
Special emphasis is given to include the following:
1. Conceptualization of principles.
2. Applications of principles.
3. A number of illustrations.
4. Question bank.
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Ch. 1. Intellectual Property Rights (IPR)
Patents
Inventions-Patentable
Copyrights
Trademarks
Geographical Indications
Industrial Designs
Integrated Circuits
Trade Secrets
Question Bank
Ch. 2. Patents in India
The Patents Act, 1970
The Patents (Amendment) Act, 1999
The Patents (Amendment) Act, 2002
The Patents (Amendment) Act, 2005
Stages of Patenting
Patent Opposition (Post Grant)
Maintaining the Patent Rights - Conditions
Patent Information – Search and Sources
Question Bank
Ch. 3. Organizations and Agreements – Intellectual Property Rights
General Agreement on Tariffs and Trade (GATT)
World Trade Organization (WTO)
World Intellectual Property Organization (WIPO)
Paris Convention
Berne Convention
TRIPS Agreement
The Doha Declaration
Patent Cooperation Treaty (PCT)
Madrid Protocol
Question Bank
Ch. 4. ISO
Quality Concepts
Quality Management – Vocabulary
ISO 9000 Series- Standards, Guidelines and Selection
Quality Management Systems – Requirements
ISO – Certification Procedure
ISO 14000
Question Bank
Ch. 5. Total Quality Management (TQM)
Principles of TQM
Elements of TQM
Continuous Improvement and Learning
Management Tools for TQM
Tools and Techniques of Quality
New Quality Tools and Techniques
Question Bank
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Ch. 6. Stability Guidelines – ICH and WHO
Food and Drug Administration (FDA)
Harmonization Efforts
ICH - Basic Principles
New Drug Substance –Stability Testing – ICH Guideline
New Drug Product – Stability Testing – ICH Guideline
ICH Guideline – Photostability Testing
ICH Guideline – Containers
WHO Stability Guideline – Basic Principles
WHO Stability Guideline
Question Bank
Ch. 7. Generic Drug Products
Drug Regulations – IND and NDA
Drug Regulations – ANDA
Generic Drug Product Development
Generic Drug Product Approval
SUPAC
Question Bank
Ch. 8. Documentation and Records (CGMP – Subpart J)
Material Identification System – Codes
Master Formula Records
Control Records
Master Production and Control Records
Batch Production and Control Records
Equipment Cleaning and Use of Log Book
Records Relating to Container, Closure and Labeling
Production Records Review
Distribution Records
Complaint’s Files
Question Bank
APPENDIX-I : Definitions and Meanings
APPENDIX-II : All in Twos – Know Them Well
APPENDIX-III : Bibliography
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