Special thanks and gratitude to my mother Smt Premwati Ghangas for being the

one who supports me, inspires me and loves me. I am grateful to my uncle Advocate

Sh. Rajbir Ghangas for inspiring me. I extend my sincere word of thanks to Sujata

Anand, Shobhit Anand, Pooja Anand and Aashish Ghangas who have always been a

constant support. Last but not the least, I express profound love to sweet children of

my family Shorya, Surya and Shakti who always act as stress reliever for me with

their innocent smile.

I have learned a lot from my students, and they deserve an equal credit for the

insights that helped create this book. I hope students will appreciate this book.

Jyoti Ghangas

Acknowledgements

Syllabus Prescribed by Pharmacy Council of India

for Bachelor of Pharmacy Course

BP 702 T. INDUSTRIAL PHARMACY II (Theory)

45 Hours

Scope: This course is designed to impart fundamental knowledge on pharmaceutical product development

and translation from laboratory to market

Objectives: Upon completion of the course, the student shall be able to:

1. Know the process of pilot plant and scale up of pharmaceutical dosage forms

2. Understand the process of technology transfer from lab scale to commercial batch

3. Know different Laws and Acts that regulate pharmaceutical industry

4. Understand the approval process and regulatory requirements for drug products

Course Content

UNIT 1 10 Hours

Pilot plant scale up techniques: General considerations-including significance of personnel requirements,

space requirements, raw materials, pilot plant scale up considerations for solids, liquid orals, semi solids

and relevant documentation, SUPAC guidelines, Introduction to platform technology

UNIT 2 10 Hours

Technology development and transfer: WHO guidelines for technology transfer(TT): Terminology,

technology transfer protocol, quality risk management, transfer from R & D to production (process,

packaging and cleaning), granularity of TT process (API, excipients, finished products, packaging

materials) documentation, premises and equipment, qualification and validation, quality control, analytical

method transfer, approved regulatory bodies and agencies, commercialization—practical aspects and

problems (case studies), TT agencies in India—APCTD, NRDC, TIFAC, BCIL, TBSE/SIDBI; TT related

documentation—confidentiality agreement, licensing, MoUs, legal issues

UNIT 3 10 Hours

Regulatory affairs: Introduction, historical overview of regulatory affairs, regulatory authorities, role of

regulatory affairs department, responsibility of regulatory affairs professionals

Regulatory requirements for drug approval: Drug development teams, non-clinical drug development,

pharmacology, drug metabolism and toxicology, general considerations of investigational new drug (IND)

application, investigator’s brochure (IB) and new drug application (NDA), clinical research/BE studies,

clinical research protocols, biostatistics in pharmaceutical product development, data presentation for