Piramal Pharma Solutions (PPS) said it completed more than 200 customer audits and secured over 70 regulatory approvals across its global network over the past fiscal year. The company described the outcomes as reflecting the strength of its long-range quality strategy, which emphasizes sustained compliance, continuous audit readiness and operational effectiveness across its contract development and manufacturing operations.
PPS’s quality approach combines governance, culture, workforce development, process harmonization and digital tools to keep sites aligned with evolving regulatory expectations. The strategy includes a comprehensive quality governance framework, predictive quality tools to assess site readiness and compliance health, and tailored systems aimed at improving efficiency and reducing the cost of poor quality.
A central component is the REsolute to SOLVE Deviations (RESOLVE) program, which is designed to drive right‑first‑time execution in manufacturing and Quality Control laboratories. Key elements of RESOLVE include concurrent batch record review, site‑wide quality ownership, shopfloor quality oversight and strengthened operational vigilance, all intended to minimize errors and support timely readiness for regulatory interactions. PPS has also rolled out specialized training to enhance audit readiness, regulatory engagement and decision‑making across its workforce.
The company said its digital initiatives are further reinforcing quality processes and transparency. The eLab platform is used to digitize QC laboratories and automate testing, with the goal of reducing errors and improving predictability and turnaround times. The exForms system digitizes GxP forms to support ALCOA compliance, speed approvals and underpin continuous audit readiness. PPS has also deployed iAssist, a validated human‑in‑the‑loop AI‑enabled tool intended to support the speed and rigor of investigations by structuring outputs, improving consistency and reducing manual effort. These tools sit alongside existing digitized quality, learning and document management systems that have been in place for several years.
Chief Quality Officer Rashida Najmi said PPS focuses on embedding quality into day‑to‑day operations so that audit readiness is “sustained, not episodic,” a stance the company argues is reflected in its recent customer and regulatory audit track record. According to PPS, the latest results demonstrate its long‑term commitment to quality and its ability to reliably support the development and manufacture of therapies for patients worldwide.