Quality at a glance

Across some of the industry's most diverse regulatory environments, inspected by: U.S. FDA · MHRA · Health Canada · TGA - Australia · PMDA · ANVISA · WHO-CDSCO · FIMEA · DEA and numerous other global authorities.
These engagements provide more than a measure of compliance performance; they generate insights that continuously strengthen our systems, improve execution, and elevate readiness across the organization.
Regulatory Inspections. Since FY2012.
Customer Audits. Since FY2012.
regulatory inspections. FY2026 alone.
Customer Audits. FY2026 alone.
Independent Governance And Oversight
The effectiveness of predictive quality depends on strong governance and independent oversight. At Piramal Pharma, the quality organization operates independently under the leadership of the Chief Quality Officer (CQO), who inturn reports into company’s Chairperson, ensuring that quality decisions remain aligned with patient safety, product quality, and regulatory expectations. Structured governance forums provide visibility from site operations to executive leadership, allowing emerging risks, quality trends, regulatory developments, and strategic priorities to be reviewed with transparency and accountability. This governance model ensures that quality considerations remain embedded in business decisions while preserving the independence necessary for objective oversight.
Quality doesn't start at manufacturing it starts before materials ever arrive on-site.

We embed critical quality, compliance, and risk checks at every stage through structured quality gates:
Development
Technology Transfer
Manufacturing
Product Release
Post-Market Surveillance
Our quality teams actively partner in the introduction of new projects, onboarding of new customers, commercialization of new molecules, and other strategic business initiatives, ensuring that quality expectations are built in from the outset rather than inspected in later.
This Extends To Our Supply Chain
Risk-based supplier selection and qualification
Ongoing supplier oversight
Trusted supplier partnership
This results in a connected ecosystem built for transparency, supply chain resilience, and patient-centric decision-making.
Predictive, Intelligence-Driven Quality
As regulatory expectations continue to evolve, we have deliberately transformed quality beyond traditional compliance oversight into a predictive and intelligence-driven discipline. Rather than waiting for issues to emerge, we focus on identifying risks early, monitoring organizational health, and enabling proactive interventions. This is achieved through a suite of internally developed quality intelligence frameworks.
Our internally developed Quality Tools give real-time visibility into:
- Quality performance and inspection readiness, across sites
- Data integrity maturity and governance effectiveness
- Combined quality, audit, and compliance indicators
Together, these frameworks enable data-driven decision making, prioritize areas requiring attention, and strengthen confidence in operational and regulatory outcomes.

Governance & Vigilance
Governance & Vigilance is further strengthened through a proactive approach to risk management. Regulatory intelligence, industry developments, inspection observations, warning letters, and emerging expectations are continuously monitored through QUENCH, our quality intelligence platform. Insights generated through QUENCH are translated into preventive actions across sites, helping teams prepare for future requirements before they become compliance challenges. This intelligence is complemented by Quality Alerts, which systematically share lessons learned across the organization, and by our Continual Improvement Program, which evaluates readiness through corporate inspections and focused quality reviews. Together, these mechanisms create an environment where learning, prevention, and preparedness become part of everyday operations rather than activities triggered solely by regulatory inspections or customer audits.
How Piramal Pharma Ensures Data Integrity and Digital Quality Enablement
Central to this ecosystem is our commitment to Data Integrity (DI) and Digital Enablement. We have a central Data integrity organization structure with site DICO (data integrity coordinators) reporting into Central DICO, who inturn reports into CQO. All and any DI violation is escalated to CQO within 24 hours and investigated as per company’s DI white paper.
Reliable data is fundamental to regulatory confidence, customer trust, and sound scientific decision-making. To support this commitment, Piramal Pharma has invested in a digital quality ecosystem that enhances transparency, traceability, efficiency, and operational control.
Digital capabilities such as:
- Catalyst eLab improve laboratory efficiency and predictability
- ExForms strengthens data integrity through digitization of GxP processes
- iAssist leverages validated artificial intelligence with human oversight to enhance investigation quality and scientific rigor
These solutions are integrated with pre deployed enterprise-wide quality platforms that support document management, quality events, training, validation lifecycle management, and quality oversight, creating a connected environment that reinforces consistency and compliance while enabling informed, data-driven decisions.

Technology alone, however, cannot create a culture of quality. Sustainable quality excellence depends on people, leadership, and shared accountability. At Piramal Pharma, quality ownership is built through a framework of Direction, Alignment, and Commitment, which creates clarity around priorities, promotes collaboration across geographies and functions, and encourages individuals at every level to take responsibility for quality outcomes. This culture is reinforced through structured capability-building programs, leadership engagement, and cross-site learning initiatives designed to strengthen technical expertise, investigation quality, regulatory awareness, and quality leadership across the organization.
This direction, alignment, and commitment is further reinforced through our Quality Meets, which bring together quality leaders across geographies to review performance, share inspection learnings, discuss emerging regulatory expectations, and align on strategic quality priorities across the network. Complementing these forums are our One Quality Townhalls, which create a common platform for communicating organizational priorities, celebrating achievements, sharing cross-site learnings, and strengthening quality culture across all levels of the organization. Together, these engagements foster transparency, collaboration, and collective ownership, ensuring that every colleague remains connected to our quality vision and committed to delivering excellence
At Piramal Pharma, every colleague is encouraged to raise concerns whenever something does not appear right from a quality, compliance, data integrity, or patient safety perspective. Supported by a structured quality escalation framework and an Open Door and Speak Up culture, employees have multiple avenues to escalate concerns, including direct access to senior quality leadership and the Chief Quality Officer. All concerns are independently reviewed, investigated as appropriate, and addressed through established governance mechanisms, ensuring transparency, objectivity, and timely resolution. This commitment to listening, acting, and learning reinforces our culture of integrity and ensures that protecting patients and product quality always remains our highest priority.
Building future-ready quality capability
150+ colleagues certified through Quality Academy, our structured development platform and growing. This creates deeper bench of quality competence in our team.
Alongside it, our Quality Long Range Plan sets the roadmap for advancing quality across systems, processes, technology and people, backed by our focussed program RESOLVE aimed at Right-First-Time Execution and stronger investigations.

What This Means for Our Stakeholders

Transparent partnerships, strong oversight, regulatory confidence.
A disciplined, proactive approach to compliance, that embraces improvements.
The confidence that quality sits at the center of every decision we make.
At Piramal Pharma, through predictive intelligence, independent governance, digital innovation, proactive risk management, and a culture of ownership, we remain committed to delivering quality that regulators can rely upon, customers can trust, and patients can have confidence in.
FAQ
We adhere to global regulatory standards set by key authorities (including US FDA, EMA, MHRA, and PMDA). Our facilities operate under a unified Global Quality Management System (QMS) to ensure seamless compliance across all manufacturing and R&D sites worldwide.
Quality is integrated into every stage of our operations from drug discovery and manufacturing to delivery. Our approach prioritizes patient safety, operational excellence, right-first-time execution, and continuous compliance.
We operate across multiple global sites with tens of thousands of successful batches released annually, supported by regular regulatory audits, client inspections, and zero-tolerance data integrity protocols.
Leadership drives a proactive quality-first mindset through formal oversight committees, standard operating procedures, regular training programs, and transparent accountability at every level of the organization.
Yes, our QMS is harmonized globally. This ensures identical standards for risk management, batch testing, facility maintenance, and compliance, regardless of where the product is manufactured.
We maintain a state of continuous audit readiness. Through regular internal assessments, mock audits, and proactive risk evaluations, our facilities are structured to meet stringencies for unannounced and scheduled inspections.
We implement electronic QMS (eQMS), automated laboratory information management systems (LIMS), and strict ALCOA+ data integrity principles to eliminate manual errors and ensure complete traceability.
We foster a continuous improvement culture using Lean Six Sigma methodologies, root-cause analysis frameworks (CAPA), employee recognition programs, and routine quality training.
Our facilities hold active approvals and certifications from leading global regulatory agencies, including the US FDA, MHRA (UK), EMA (Europe), PMDA (Japan), ANVISA (Brazil), and Health Canada, among others.
Our promise is to deliver safe, effective, high-quality healthcare solutions built on absolute integrity, transparent partnerships, and relentless commitment to global health standards.
All suppliers, raw material vendors, and strategic partners undergo rigorous qualification, periodic audits, and raw material testing under our global vendor risk management protocol before integration into manufacturing.
Every employee undergoes continuous, role-specific GxP training, data integrity workshops, and annual compliance assessments to embed a proactive quality-first mindset at every operational level.


