Pharmaceutical Regulatory Affairs (SELECTED TOPICS)
  by C.V.S. Subrahmanyam & J. Thimma Setty
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   ISBN 978-81-85731-70-4; 1st Ed. 2012; Rpt 2019; pp.viii+272

   Delhi price: 250      Outside Delhi price: 265      Overseas price : 750

 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.


Ch. 1. Intellectual Property Rights (IPR)
       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

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
       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