Academic Quality Assurance PCI 2026 (NEP 2020) Paid Access

Pharmaceutical Quality Assurance (Theory)

By Harshali Yuvraj Tayade, Monali Pratik Aher & Mahadevan R Swamy

This comprehensive textbook has been written for students of the fifth semester of the Bachelor of Pharmacy programme in India, following the revised syllabus of the Pharmacy Council of India for paper BP505T. The book covers the foundations of pharmaceutical quality including Quality Control, Quality Assurance, Good Manufacturing Practice, Total Quality Management, ICH harmonisation, ISO standards, and the critical aspects of calibration, qualification, and validation that anchor every measurement and method in pharmaceutical manufacturing.
Category
Quality Assurance
Target Audience
B.Pharm V Semester Students
Course Code
BP505T
Syllabus
New PCI 2026 (NEP 2020)
ISBN
978-81-687160-1-8
Lecture Hours
45 Hours (5 Units)

About This Book

The syllabus covers, in five units and forty-five lecture hours, the foundations of pharmaceutical quality (concepts of Quality Control, Quality Assurance and Good Manufacturing Practice; Total Quality Management and modern quality management systems; ICH harmonisation and Quality by Design; ISO 9000, ISO 14000 and NABL accreditation), the organisation and physical environment of pharmaceutical manufacture (organisation and personnel; premises, plant layout and environmental control; equipment, raw materials and warehousing), the analytical confirmation of product quality (in-process and finished-product Quality Control tests; QC of raw and packaging materials; Good Laboratory Practices), the documentation that records what is done (documents in the pharmaceutical industry; complaints, recalls and waste disposal) and the calibration, qualification and validation that anchor every measurement and every method.

Keywords

Quality Assurance Quality Control GMP Total Quality Management ICH Guidelines Quality by Design ISO 9000 ISO 14000 NABL Accreditation Validation Calibration GLP B.Pharm BP505T PCI Syllabus 2026 NEP 2020

How to Cite

Tayade, H. Y., Aher, M. P., & Swamy, M. R. (2026). Pharmaceutical Quality Assurance (Theory) (1st ed.). WiseLeaf Scientific Ventures. ISBN: 978-81-687160-1-8

DOI: 10.66079/wiseleaf.pqa.2026

Paid Access — Preview the first 20 pages for free. Full book will be available for purchase through our partner platforms.

Back to Books Catalog