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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.
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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
SUPAC
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
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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
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