Hemant

Blog by Hemant

Beyond the Primary Method
A risk-based strategy for developing orthogonal analytical methods during R&D for high-risk pharmaceuticals. Grounded in ICH Q14 and USP <1220>, this proactive approach mitigates supply disruptions, method failures, and OOS investigations—transforming CMC into a resilient, lifecycle-ready system
16.01.26 07:50 PM - Comment(s)
The Analytical Renaissance in Pharma QC


Mr. Hemant Patil, Pharmaceutical Professional

Affiliation: AscentCoAI Pharma

Correspondence: hemant@ascentcoaipharma.com


Keywords: UPLC, HPLC modernization, method consolidation, ICH Q2(R2), ICH Q12, data integrity, potentiometric titration, method development, method validation, Quality, lifecycle man...



16.01.26 06:28 PM - Comment(s)
Data Integrity in Pharma: 
An expert perspective on data integrity as the foundation of pharma compliance, quality culture, inspection readiness, and global business sustainability—linking ALCOA+, regulatory expectations, R&D, technology transfer, and patient safety into a strategic framework.
23.12.25 04:40 PM - Comment(s)