Name: Pharmaceutical Validation for Master of Pharmacy Students
Brand: CBS Publishers and Distributors
SKU: 9788199075214
Rating: 5 (0 reviews)

Descriptions

This book discusses calibration, qualification and validation, the key concepts in pharmaceutical manufacturing to ensure product quality and compliance. Calibration ensures instruments give accurate measurements. Qualification confirms equipment operates as intended. Validation ensures that processes consistently produce results meeting predefined specifications.

Calibration focuses on accuracy, whereas validation covers the entire process. Validation includes types like process, cleaning, analytical method, and computerized system validation. Equipment such as dryers, mixers, and sterilizers must be qualified before use in production. Analytical instruments like HPLC, UV-Vis, and FTIR require qualification for reliable data. Utilities like HVAC and water systems must also be qualified and validated. Analytical method validation follows ICH and USP guidelines to ensure accurate drug analysis. Computerized systems must comply with 21 CFR Part 11 and GAMP 5 for data integrity and regulatory approval.

Specifications

ISBN	9788199075214
Published Year	2026
Binding	Paperback
Subject	Pharmaceutical Validation
Pages	120
Weight	0.200 (In Kg)
Dimension	21.5 × 14 × 0.5
Readership	MPharma

About the Author

P

Paul Richards M

Dr. Paul Richards M, MPharm, PhD, is currently a Professor and Head of the Department of Pharmaceutical Analysis at Aditya Bangalore Institute of Pharmacy Education and Research, Bangalore. He served as the IQAC Coordinator, during which the institute achieved a B++ accreditation from NAAC. He is also an Executive Committee (EC) member of the IPA Urban Local Branch and acted as the convener for the 11C Institution Innovation Council. Dr. Richards is a life member of IPA, APTI, and IPGA. With a total of 15 years of experience, he has expertise in handling UV and HPLC instruments and has guided 40 postgraduate (PG) students. Dr. Richards has published numerous research articles and review articles in various journals indexed in Scopus and the Web of Science. He holds patents granted by India and Germany. He is also ratified by JNTUH and RGUHS Universities to guide PG students. Dr. Richards qualified in GPAT with a 92 percentile and has received various UG grants from RGUHS. He completed his PGDCQAM from the School of Chemistry, Telangana. Additionally, he has attended numerous national and international conferences and received the Best Oral Presentation Award from Amity University.

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