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 in the past fiscal year. The strong outcomes highlight the effectiveness of the company's long-range quality strategy and its commitment to scientific excellence and continuous improvement.
Quality Strategy and Governance Framework
PPS's quality strategy integrates robust governance, quality culture initiatives, workforce development, process harmonization, and digital transformation to ensure sustained compliance, continuous audit readiness, and operational effectiveness. This proactive approach enables the company to 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 for assessing site readiness and compliance health, and tailored systems that improve efficiency and reduce the cost of poor quality. The 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.
Digital Transformation Enhancing Quality Processes
Digital platforms are strengthening quality processes at PPS by increasing efficiency and transparency across global operations. The eLab system digitizes QC laboratories and automates testing processes, reducing errors and improving predictability and turnaround times. The exForms program 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 that supports the speed and rigor of investigations by 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 Commitment
Rashida Najmi, PPS's Chief Quality Officer, stated: "At Piramal Pharma Solutions, quality is integral to everything we do. 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."
Regulatory and Customer Audit Track Record
The successful completion of over 200 customer audits and receipt of more than 70 regulatory approvals demonstrates PPS's long-term commitment to quality and its ability to consistently deliver safe, effective therapies to patients worldwide. The company's global network includes facilities in North America, Europe, and Asia, offering end-to-end development and manufacturing solutions across the drug life cycle.
About Piramal Pharma Solutions and Piramal Pharma Limited
Piramal Pharma Solutions (PPS) provides comprehensive services including drug discovery, process and pharmaceutical development, clinical trial supplies, commercial supply of APIs, and finished dosage forms. It also offers specialized services for highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products, and potent solid oral drug products. PPS also provides development and manufacturing services for biologics, including vaccines and gene therapies, through Piramal Pharma Limited's associate company, Yapan Bio Private Limited.
Piramal Pharma Limited (PPL) offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a distribution network in over 100 countries. PPL includes Piramal Pharma Solutions, Piramal Critical Care (a complex hospital generics business), and the Piramal Consumer Healthcare business. One of PPL's associate companies, Abbvie Therapeutics India Private Limited, is a market leader in ophthalmology in India. PPL also has a strategic minority investment in Yapan Bio Private Limited, which operates in the biologics and vaccine segments.
