|
About The Book
Industrial pharmacy is a discipline that supervises and ensures a quality check of the phases of product development from manufacturing to marketing and distributing the drugs. Perfect clinical trial with authentic regulatory submission is very important to carry successful execution of the drug development process.
This book imparts basic knowledge of Industrial Pharmacy and clinical trials alongwith regulations according to the syllabus of Industrial Pharmacy II, Final Year B. Pharmacy (Semester-VII) designed by Pharmacy Council of India, New Delhi as per the revised regulations for the Bachelor of Pharmacy degree program Course regulations 2014.
Special interest has been taken in adhering to the topics such as process of pilot plant and scale up of pharmaceutical dosage forms, technology transfer from lab scale to commercial batch, quality management systems, clinical trials and regulatory requirements for drug approval. Theoretical knowledge on these topics can be quite useful for pursuing a career as an industrial pharmacist or in regulatory department.
The content is written in simple manner and revision questions are also provided at the end of each chapter to make the book student-friendly.
|
|
1 PILOT PLANT SCALE UP TECHNIQUES
Introduction
Objectives
Components
Pilot plant scaleup consideration for solid orals
Pilot plant Scaleup consideration for liquids
Pilot plant Scaleup consideration for semisolids
Documentation
SUPAC
Platform technology
2 TECHNOLOGY DEVELOPMENT AND TRANSFER
Introduction
Objectives
Protocol
R & D to production transfer
Analytical technology transfer
Qualification and Validation
Documentation
Quality risk management
Regulatory bodies and agencies
WHO Guidelines
3 QUALITY MANAGEMENT SYSTEMS
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
|
4 REGULATORY AFFAIRS
Introduction
History of Pharmaceutical Regulatory Affairs
Pharmaceutical Regulatory agencies
Roles and responsibilities
5 REGULATORY REQUIREMENTS FOR DRUG APPROVAL
Drug development process
Drug development teams
Clinical trial protocol
Clinical trial data collection and management
Bioavailability and Bioequivalence studies
Biostatistics in pharmaceutical product development
6 INDIAN REGULATORY REQUIREMENTS
Central Drug Standard Control Organization (CDSCO)
Regulatory requirements and approval procedures for New Drugs
Certificate of Pharmaceutical Product (COPP)
APPENDICES
|