Piramal Pharma Solutions Achieves Strong Audit Outcomes
Piramal Pharma Solutions (PPS), a global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd. (NSE: PPLPHARMA) (BSE: 543635), 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. This milestone underscores the strength of the company's long-range quality strategy and its commitment to scientific excellence and continuous improvement.
Quality Strategy Drives Sustained Compliance
PPS's quality strategy integrates robust governance, quality culture, workforce development, process harmonization, and digital transformation to ensure sustained compliance, continuous audit readiness, and operational effectiveness. This approach enables the company to 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 to assess site readiness and compliance health, and tailored systems that improve efficiency and reduce the cost of poor quality. The company's RESOLVE program (REsolute to SOLVE Deviations) drives right-first-time execution in manufacturing and Quality Control (QC) laboratories, minimizing errors and supporting timely regulatory readiness. Core initiatives include concurrent batch record review, site-wide quality ownership, shopfloor quality oversight, and strengthened operational vigilance. Specialized training programs further enhance audit readiness, regulatory engagement, and decision-making.
Digital Transformation Strengthens Quality Processes
Digital platforms are enhancing efficiency and transparency across PPS's global operations. eLab digitizes QC laboratories and automates testing processes, reducing errors while improving predictability and turnaround times. exForms digitizes GxP forms to support ALCOA compliance, improve accessibility, accelerate approvals, and reinforce continuous audit readiness. Additionally, PPS 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 on Quality Culture
"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's successful regulatory and customer audit track record demonstrates the company's long-term commitment to quality and reinforces its ability to consistently deliver safe, effective therapies to patients worldwide.
About Piramal Pharma Solutions and Piramal Pharma Limited
Piramal Pharma Solutions offers end-to-end development and manufacturing solutions across the drug life cycle, serving customers through a globally integrated network of facilities in North America, Europe, and Asia. Services include drug discovery solutions, process and pharmaceutical development, clinical trial supplies, commercial supply of APIs, and finished dosage forms. Specialized services include development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products, and potent solid oral drug products. PPS also offers biologics development and manufacturing services through Piramal Pharma Limited's associate company, Yapan Bio Private Limited.
Piramal Pharma Limited (PPL) offers a portfolio of differentiated products and services through 17 global development and manufacturing facilities and a distribution network in over 100 countries. PPL includes Piramal Pharma Solutions, Piramal Critical Care (complex hospital generics), and Piramal Consumer Healthcare (OTC products). Abbvie Therapeutics India Private Limited, a joint venture between Abbvie and PPL, is a market leader in ophthalmology in India. PPL also has a strategic minority investment in Yapan Bio Private Limited.
