Namji says discipline helps deliver consistency and reliability customers expect
Mumbai-listed Piramal Pharma Solutions (PPS), a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd (NSE: PPLPHARMA) (BSE: 543635), has 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 harmonization, 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 minimize 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 specialized training programs to enhance audit readiness, regulatory engagement, and decision-making, further strengthening quality capabilities across the organization.
Digital platforms are further strengthening quality processes at PPS by increasing efficiency and transparency across global operations. With eLab, PPS digitizes QC laboratories and automates testing processes, helping reduce errors while improving predictability and turnaround times. Complementing that program is exForms, which digitizes 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 rigor of investigations. The tool helps structure investigation outputs, improve consistency, and reduce manual effort for PPS teams. These additions complement already digitized QMS, LMS and DMS platforms, which have been functional for several years now.
“At Piramal Pharma Solutions, quality is integral to everything we do,” Rashida Najmi, PPS’s Chief Quality Officer, said on 22 June. “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.
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products and services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines and gene therapies, made possible through Piramal Pharma Limited’s associate company, Yapan Bio Private Limited. Fiinews.com
