Flagship Academic Industrial Pharmacy PCI 2026 (NEP 2020) Paid Access

Industrial Pharmacy and Facility Design

By Diksha, Mohd. Zafar & Prof. Navneet Verma

Where earlier courses treat the science of individual dosage forms, this course treats the industrial system that turns a proven formulation into a marketed medicine: the regulatory framework that governs development, the scale-up and technology transfer that move a product from the bench to the plant, and the design of the facilities and utilities in which medicines are actually made. The book is written around a single connecting idea, that quality is designed into a product and its process and then protected at every subsequent stage, rather than tested in at the end.
Category
Industrial Pharmacy
Target Audience
B.Pharm VIII Semester Students
Course Code
BP803T
Syllabus
New PCI 2026 (NEP 2020)
ISBN
978-81-903393-6-0
Lecture Hours
45 Hours (5 Units)

About This Book

This book has been written for students of the Bachelor of Pharmacy programme studying Industrial Pharmacy and Facility Design (BP803T) in the eighth semester, and for the teachers who guide them. The subject occupies a distinctive place in the curriculum, treating the industrial system rather than the individual dosage form.

The book follows the prescribed syllabus unit by unit. Each regulatory requirement is presented together with the reason it exists and the way a plant demonstrates that it has been met, so that the student reads the syllabus not as five disconnected topics but as one continuous account of how a medicine of assured quality is made. Every chapter carries learning outcomes, quick-recall boxes, worked examples, a chapter summary, and self-assessment with short-answer, long-answer and multiple-choice questions.

Table of Contents

  1. Regulatory Guidelines for Formulation Development
  2. Pilot Plant Scale-Up and Industrial Product Development
  3. Technology Development and Transfer
  4. Non-Sterile Facility Design and Pharmaceutical Water and Utility Systems
  5. Layout, Cleaning and Disinfection for Non-Sterile Facilities
  6. Sterile Facility Design, Cleanrooms and Contamination Control
  7. HVAC Systems and Cleanroom Qualification
  8. Advances in Facility Design: Modular Facilities, Isolators and Automation

Keywords

Industrial Pharmacy Facility Design Quality by Design ICH Q8 Stability Testing Pilot Plant Scale-Up SUPAC Guidelines Technology Transfer Schedule M Pharmaceutical Water Systems Cleanroom Classification HVAC and HEPA Filtration Cleaning Validation Modular Facilities and Isolators B.Pharm BP803T PCI Syllabus 2026 NEP 2020

How to Cite

Diksha, Zafar, M., & Verma, N. (2026). Industrial Pharmacy and Facility Design (1st ed.). WiseLeaf Scientific Ventures. ISBN: 978-81-903393-6-0

DOI: 10.66079/wiseleaf.industrial-pharmacy-facility-design-bp803t-flagship.2026

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