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Piramal Pharma Solutions Achieves Milestone in Customer Audit Approvals

Piramal Pharma Solutions (PPS), a prominent player in the Contract Development and Manufacturing Organization (CDMO) sector, has recently announced impressive milestones reflecting their unwavering commitment to quality and client satisfaction. Over the past fiscal year, the company successfully completed more than 200 customer audits and garnered over 70 approvals from various regulatory agencies through its extensive global network. This achievement underlines the effectiveness of PPS’s long-term quality strategy designed to ensure compliance, operational efficiency, and ready availability for audits.

A Robust Quality Strategy

The strength of Piramal’s quality strategy is attributed to many factors. Rashida Najmi, the Chief Quality Officer at Piramal Pharma Limited, noted that their approach encompasses robust governance, an ingrained quality culture, and comprehensive workforce development. By harmonizing processes across their operations, the company effectively addresses the evolving landscape of regulatory expectations, ensuring high levels of operational readiness.

Piramal’s focus on quality is not confined to the conventional frameworks; it extends to integrating digital transformation into their operations. They employ innovative tools and technologies to bolster quality governance and compliance, which significantly enhances their preparedness for regulatory inspections.

Key Elements of Their Success

PPS’s unique strategy incorporates several critical components:
1. Quality Governance Framework: A structured approach that governs the entire quality management process.
2. Predictive Quality Tools: These tools assess compliance readiness proactively, allowing the organization to identify potential issues before they escalate.
3. Tailored Systems: Customized systems are in place to streamline operations and minimize the cost associated with poor quality.

The RESOLVE program, which stands for REsolute to SOLVE Deviations, is another initiative that ensures manufacturing and Quality Control (QC) labs can execute tasks right the first time. This program effectively reduces errors and enhances regulatory readiness by instituting practices such as concurrent batch record reviews and site-wide quality ownership.

Moreover, specialized training enhances audit readiness and regulatory engagement, strengthening overall quality capabilities across the organization.

Embracing Digital Transformation

In today's increasingly digital world, Piramal Pharma Solutions is leveraging technology to enhance its quality processes further. Their eLab initiative digitizes QC laboratories and automates testing processes, which plays a key role in minimizing errors and improving turnaround times. Another important aspect of their digital transformation is exForms, which digitizes Good GxP (Good Practice) forms to bolster ALCOA compliance. This initiative streamlines approvals and fosters continuous audit readiness.

Additionally, through the use of iAssist, an AI-enabled tool, PPS aims to enhance the speed and rigor of investigations by structuring outputs, thereby also reducing the manual effort required for their teams.

Building a Culture of Quality

Najmi asserts, “At Piramal Pharma Solutions, quality is integral to everything we do.” This philosophy ensures that quality is embedded in the daily operations of the organization rather than being a sporadic focus. By maintaining this discipline, PPS aims to deliver the reliability and consistency that their clients expect and deserve.

The successful track record of regulatory and customer audits not only reaffirms Piramal’s dedication to quality but also solidifies its standing as a trustworthy supplier, capable of providing safe and effective therapies to patients worldwide.

About Piramal Pharma Solutions

Piramal Pharma Solutions is a leader in offering comprehensive development and manufacturing solutions across the drug lifecycle. With a globally integrated network spanning North America, Europe, and Asia, the organization provides a wide array of services that include drug discovery, clinical trial supplies, and commercial API supply, among others. The company’s commitment to excellence is reflected not only in their procedures but also in their proactive approach to fulfilling clients’ needs in this high-stakes industry.