Piramal Pharma Solutions (PPS), a global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd., announced that it completed more than 200 customer audits and received over 70 approvals from regulatory agencies across its global network over the past fiscal year. The positive outcomes underscore the company’s long-range quality strategy focused on sustained compliance, continuous audit readiness, and operational effectiveness.
Quality Strategy and Governance
PPS’s quality strategy integrates robust governance, quality culture initiatives, workforce development, process harmonization, and digital transformation to support sustained compliance and operational effectiveness. This approach helps the company proactively address evolving regulatory expectations while maintaining high readiness across its global development and manufacturing operations.
Key elements include a comprehensive quality governance framework, predictive quality tools that assess site readiness and compliance health, and tailored systems that improve efficiency and reduce the cost of poor quality.
RESOLVE Program and Training
PPS’s REsolute to SOLVE Deviations (RESOLVE) program drives right-first-time execution in manufacturing and Quality Control (QC) laboratories, minimizing errors and supporting timely readiness for regulatory interactions. Core initiatives include concurrent batch record review, site-wide quality ownership, shopfloor quality oversight, and strengthened operational vigilance. The company has also implemented specialized training programs to enhance audit readiness, regulatory engagement, and decision-making.
Digital Transformation
Digital platforms are strengthening quality processes by increasing efficiency and transparency. With eLab, PPS digitizes QC laboratories and automates testing processes, reducing errors while improving predictability and turnaround times. Complementing this is exForms, which digitizes GxP forms to support ALCOA compliance, improve accessibility, accelerate approvals, and reinforce continuous audit readiness. Additionally, the company has adopted iAssist, a validated human-in-the-loop AI-enabled tool designed to support the speed and rigor of investigations, structuring outputs, improving consistency, and reducing manual effort. These tools complement already digitized QMS, LMS, and DMS platforms that have been functional for several years.
Leadership Perspective
“At Piramal Pharma Solutions, quality is integral to everything we do,” said Rashida Najmi, PPS’s Chief Quality Officer. “Our focus is on building quality into everyday operations so that audit readiness is sustained, not episodic. That discipline helps us deliver the consistency and reliability our customers expect.”
