This milestone reflects the Company’s long-range quality strategy focused on sustained compliance, continuous audit readiness, and operational effectiveness. Through robust governance, quality culture initiatives, workforce development, and digital transformation, Piramal continues to strengthen its position as a reliable global CDMO partner.
Piramal Pharma Solutions (“PPS”), a leading global Contract Development and Manufacturing Organisation (CDMO) and part of Piramal Pharma Ltd. (NSE: PPLPHARMA | BSE: 543635), today 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 reflect the strength of the Company’s long-range quality strategy and its ongoing commitment to scientific excellence and continuous improvement.
PPS’s quality strategy combines robust governance, quality culture, workforce development, process harmonisation, and digital transformation to support sustained compliance, continuous audit readiness, and operational effectiveness. This approach helps the Company proactively address evolving regulatory expectations while maintaining a high level of readiness across its global development and manufacturing operations.
Key elements of this strategy include a comprehensive quality governance framework, predictive quality tools that help assess site readiness and compliance health, and tailored systems that improve efficiency and reduce the cost of poor quality. PPS’s REsolute to SOLVE Deviations (RESOLVE) program drives right-first-time execution in manufacturing and Quality Control (QC) laboratories, helping minimise errors and support timely readiness for regulatory interactions. Core initiatives within the program include concurrent batch record review, site-wide quality ownership, shopfloor quality oversight, and strengthened operational vigilance. As part of its broader approach, the Company has also implemented specialised training programs to enhance audit readiness, regulatory engagement, and decision-making, further strengthening quality capabilities across the organisation.
Digital platforms are further strengthening quality processes at PPS by increasing efficiency and transparency across global operations. With eLab, PPS digitises QC laboratories and automates testing processes, helping reduce errors while improving predictability and turnaround times. Complementing that program is exForms, which digitises GxP forms to support ALCOA compliance, improve accessibility, accelerate approvals, and reinforce continuous audit readiness. To further these efforts, the Company has adopted iAssist, a validated human-in the-loop AI-enabled tool designed to support the speed and rigour of investigations. The tool helps structure investigation outputs, improve consistency, and reduce manual effort for PPS teams. These additions complement already digitised QMS, LMS and DMS platforms, which have been functional for several years now.
“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.”
PPS successful regulatory and customer audit track record firmly demonstrates the Company’s long-term commitment to quality and further reinforces its ability to consistently deliver safe, effective therapies to patients worldwide.
