Industrial Pharmacy-II
  by C.V.S. Subrahmanyam & J. Thimmasetty
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   ISBN 978-93-85529-50-4; 1st Ed. 2022; pp. viii+384

   Delhi price: 300      Outside Delhi price: 315      Overseas price : 900

 About The Book  

   The book ‘Industrial Pharmacy–II' includes topics related to technology transfer (including pilot plant and scale up) and associated regulatory activities, national and international. Further, good industrial practices are described. Several topics of relevance and current interest with respect to the pharmaceutical industry are described in our earlier books (both are from Vallabh Prakashan, Delhi), 1) Pharmaceutical Production and Management and 2) Industrial Pharmacy – Selected Topics.

   The book consists of 15 chapters, Pharmaceutical Pilot Plant, Scale Up Techniques – Principles, Platform Technologies in Pharmaceutical Development, Technology Transfer and Development. Total Quality Management, ISO Series, QbD in Pharmaceutical Development, Pharmaceutical Quality System (ICH Q10), Investigation of OOS in Pharmaceutical Production, Regulatory Aspects of Change Control in Pharmaceuticals, Good Laboratory Practice – Regulations, National Accreditation Board for Testing and Calibration Laboratories (NABL), Regulatory Requirements for Drug Approvals and Indian Regulatory Systems and Requirements. The reader-friendly format is maintained throughout the book. Every chapter starts with the objectives and ends with a summary. Attention is given to include the following:—

         1. Conceptualization of principles with illustrations, on the lines of concept mapping.
         2. Application of principles
         3. Question bank for drawing the attention of relevant particulars.


  1. Pharmaceutical Pilot Plant Process
     Scale of Batches
     Layout of Pharmaceutical Pilot Plant
     Organizational Structure and Personnel – Pilot Plant
     Activities – Pilot Plant
     Tablets – Pilot Plant
     Hard Gelatin Capsules – Pilot Plant
     Solution Dosage Forms – Pilot plant
     Disperse Systems – Pilot Plant
     Parenteral Products – Pilot Plant

  2. Scale Up Techniques – Principles
     Principles of Similarity
     Dimensional Analysis
     Scale up Techniques – Mixing

  3. Platform Technologies in Pharmaceutical Development
     Gemicel Platform – Assembly Biosciences
     LTLD Platform – CELSION
     Arcelis Platform – Argo's Therapeutics
     DNA Based Vaccine Platform – CICAL
     Antibodies Harnessing Platform – XBIOTECH

  4. Technology Development and Transfer
     WHO Guideline for Technology Transfer
     Regulatory Authorities and International Agencies in Technology Transfer
     Technology Transfer Support Agencies in India
     Technology Transfer – Agreements, Licenses and Legal Issues
     Pharmaceutical Industry in India – Technology Transfer

       5. Total Quality Management (TQM)
     Principles of TQM
     Elements of TQM
     Continuous Improvement and Learning
     Management Tools for TQM
     Tools and Techniques of Quality

  6. Quality Concepts and ISO
     International Organization for Standardization (ISO)
     ISO 9000 Series – Standards, Guidelines and Selection
     ISO – Certification Procedure
     Environmental Management System

  7. Quality by Design (QbD) and Pharmaceutical Development
     Regulatory View of QbD
     USFDA’s View of QbD

  8. Pharmaceutical Quality Systems (ICH Q10)
     Pharmaceutical Quality Systems – Elements

  9. Investigation of OOS in Pharmaceutical Production
     Procedure of OOS Investigations

10. Regulatory Aspects of Change Control
     Operation of Change Control
     Change Control Process – Documentation

11. Good Laboratory Practice – Regulations
     Fundamental Principles of GLP

12. NABL – Accreditation Process
     Procedure for NABL Accreditation
     Proficiency Testing Provider

13. Drug Regulatory Affairs
     Historical Overview of Regulatory Affairs
     Drug Regulatory Authorities
     Regulatory Affairs Department

14. Regulatory Requirements for Drug Approvals
     Drug Development Teams
     Drug Regulations of Preclinical Drug Development
     Regulations of Investigational New Drug (IND)
     Regulations – New Drug Application (NDA)
     Investigator's Brochure (IB) – Clinical Trials
     Regulatory Aspects of Clinical Research Protocol-IND
     Management of Clinical Studies
     Drug Regulations – BA and BE Studies
     Data Presentations for FDA Submission
     Regulatory Aspects – Statistics

15. Indian Regulatory Systems and Requirements
     Central Drugs Standard Control Organization (CDSCO)
     State Licensing Authority
     Certificate of Pharmaceutical Product
     Regulatory Approval for New Drugs in India

     APPENDIX I : Answers to the Comments
     APPENDIX II : Key to MCQs
     APPENDIX III : Definitions and Meanings
     APPENDIX IV : Bibliography