Why Rashida Najmi believes in running quality on trust, not vigilance 

In your article for Express Pharma in April 2019, you mentioned that quality needs to be part of culture, beyond compliance. (https://www.expresspharm a.in/quality-from compliance-to-culture/) Can you give practical examples of how Piramal Pharma has implemented this? What’s been the stance of the pharma industry, given the growing importance of quality culture and compliance in global pharma manufacturing, backed by increasing regulatory rigour? 

I will take your second question first. Across the industry, quality is no longer a choice; it is a necessity. Quality cannot be confined to a department—it has to be embedded in the culture. Whether it is manufacturing, clinical research or any other life sciences function, we are dealing with people’s lives. So quality cannot be optional; it has to be integral to everything we do. 

At Piramal Pharma, one of the most important steps we have taken is building futureready teams—not just within quality, but across all associated functions. We already had a strong quality foundation, but we have significantly strengthened our teams to make them high performing and future ready. We also launched our own internal Quality Academy to build what we call our quality DNA. It is a 20-month programme that takes employees through every aspect of quality at Piramal Pharma. Since we operate with harmonised quality standards across all our geographies and sites, the academy helps employees understand our quality philosophy, systems and expectations. More than 200 employees have graduated from the programme, and after completing Phases One and Two, we are preparing to launch the next phase. Continuous learning is critical because regulations evolve rapidly.

We also restructured our quality organisation at the global, regional and site levels to ensure the right balance between strategy and execution. The global team focuses primarily on strategy, regional teams balance strategy and execution, while site teams focus largely on execution with site-specific strategic responsibilities. Strategic direction flows from the global team, while regular quality town halls ensure alignment across the organisation. These sessions help everyone stay updated on evolving regulations, standards and expectations. 

Another important initiative has been strengthening regulatory compliance across every business and site. As data integrity became increasingly important, we established a dedicated Data Integrity Coordinating Officer (DICO) structure. Every site has its own DICO, reporting to a central DICO, who in turn reports directly to me. Any data integrity event is escalated to me within 24 hours. We also have a defined white paper outlining how such events are handled. Our teams are empowered to make decisions within their responsibilities, supported by a robust escalation framework. This balances operational autonomy with strong governance, ensuring that critical issues receive timely attention at the global level. 

Customer engagement has also become an important part of our quality culture. We conduct regular Quality Steering Committee meetings with customers, bringing together both quality teams to align expectations, review performance and strengthen collaboration. 

We have also built a sustainable, scalable and quality-led global supply chain. Consistent quality depends on consistent availability of materials, supported by clearly defined assets and capable teams across our global network. Digitisation has been another major focus area. We have significantly expanded automation across our quality systems, and my goal is to make our shop floors completely paperless over time. Today, digitisation is no longer optional—it is as essential as quality culture itself. 

In addition, we established a central governance and compliance cell that works closely with every business and site to continuously strengthen compliance. We have also moved high-volume, low complexity compliance activities from international sites to our central shared services team in India. This gives us economies of scale, enables 24×7 operations across time zones and allows site teams to focus on higher-value activities. Ultimately, the most important message remains the same: quality is everyone’s responsibility. My team may be the torchbearers and custodians of quality, but every employee owns it. This philosophy has enabled us to maintain perpetual audit readiness. You cannot become inspection-ready only when an audit is announced—you have to be ready every single day. Our quality track record reflects that commitment. 

When we talk about the company’s quality track record, what has been Piramal Pharma’s history with 483s, warning letters and other regulatory actions? 

Our track record speaks for itself. Over the past 15 years, across our 17 manufacturing sites, the majority of which are regulated by the US FDA, European, UK, Japanese and Australian authorities, we have not received a single Official Action Indicated (OAI). 

During this period, we have successfully undergone more than 200 regulatory inspections, over 2,000 customer inspections and more than 50 US FDA inspections. We have not received a warning letter, consent decree, letter of noncompliance or any major regulatory non-compliance from the US, Europe, UK or any other regulatory agency. 

That reflects both the strength of our quality systems and the consistency of our execution. Across the organisation, we undergo around 150-160 inspections every year when regulatory and customer audits are combined. In effect, almost every other day is an inspection somewhere within the company. That is why we maintain continuous inspection readiness. 

For us, compliance is not about meeting regulations because we have to—it is about doing the right thing. I always tell my teams not to begin with the regulations during execution. Instead, ask what is right for the patient. If you do what is right for the patient, you will naturally meet regulatory requirements. 

That is also why I say we run quality through trust, not vigilance. Regulations are important, but simply telling people to comply because of regulation is not enough. We want people to understand why quality matters and why doing the right thing is important. When people are guided by that mindset, regulatory compliance follows naturally.

How are pharma companies adapting to evolving regulatory expectations, especially global CDMOs like Piramla Pharma operating across multiple geographies? Does biologics manufacturing add further complexity? 

A patient is a patient, whether the medicine is a small molecule or a biologic. 

Every molecule has different characteristics, therapeutic effects and potential adverse effects. Naturally, biologics—including mRNA therapies, RNA vaccines, gene therapies, antibody-drug conjugates (ADCs) and injectable biologics—bring additional complexity. We manufacture biologic injectables and ADCs ourselves. The key is to develop quality systems that are appropriate for each molecule and ensure patient safety and efficacy. As complexity increases, your quality systems, processes, mindset and, most importantly, your teams must evolve accordingly. 

Regarding changing regulations, I do not see regulators simply as regulators. I see them as an extension of my own quality organisation, helping us make the right decisions for patients. Their role is to ensure patient safety, and if they identify something we have missed, we welcome that feedback. To manage evolving global standards, we have a robust global quality risk management system. If an issue arises at one site, it is immediately communicated across our global network so that similar risks can be identified and addressed proactively elsewhere. 

Within our central quality organisation, we also have a team that continuously monitors warning letters, emerging regulatory expectations and developments across global regulatory agencies. Relevant updates are shared across the organisation through our Quality Intelligence Platform, QUENCH. 

QUENCH allows us to proactively monitor regulatory developments and prepare well before new requirements become mandatory. For example, we tracked the nitrosamine issue from the very beginning and achieved full compliance within the August 2025 regulatory timeline. 

As a CDMO, staying ahead of regulatory changes is critical. While some companies struggle to be ready when new expectations emerge, our tracking systems, structured reviews and cross-learning sessions help us respond proactively. Regulatory expectations will continue to evolve, and the industry must evolve with them. Rather than resisting these changes, we should embrace them. I have personally participated in working groups that helped develop several global standards, including those relating to particulate matter in injectables, nonantibacterial beta-lactams and nitrosamines. 

Ultimately, technology and systems are important, but future-ready teams remain equally critical. Strong quality culture, automation and capable people must all work together.

What technologies are helping pharma companies meet the rising regulatory bar? How close are you to your goal of becoming paperless, and how much is Piramal Pharma investing in these technologies? 

We are very close to achieving a paperless environment at our regulated sites. 

Automation has been part of our quality strategy for many years—it is not something we adopted recently. Our quality management systems and document management systems have long been digitised, significantly strengthening compliance. 

We are now expanding several additional digital platforms. One of our biggest initiatives is migrating from SAP to SAP S/4HANA. The rollout has already been completed across our India sites and will be completed across the organisation next year. 

SAP S/4HANA will become a major data lake for quality information, supporting every stage from vendor qualification through product delivery. There are around 15-16 quality intervention points across that lifecycle, all of which are integrated into the system. While these processes were already managed digitally, we are now scaling them through a much more robust platform. 

Our digitalisation journey, however, will never really end because technology keeps evolving. We have also begun our AI journey within quality. AI is advancing rapidly, and we need to keep pace with new developments so that we can continue strengthening our quality systems. We are embarking on an AI journey in GxP processes keeping human in the loop and working with a partner who understands the life science space well. 

We have made significant investments in automation, with a significant percentage of our infrastructure-related spend currently directed towards automation and digital technologies. This proportion is expected to increase as automation becomes central to our capital expenditure planning. Every new manufacturing facility is designed with automation built in from the outset, whether through SCADA, MES, LIMS or other digital systems. Alongside expanding our facilities, we are also upgrading existing plants with newer technologies. Automation is becoming central not only to our operations, but also to our long-term investment strategy. 

What would you estimate as the industry benchmark for technology investment? 

It varies significantly from company to company because it depends on each organisation’s priorities and mindset towards automation.For companies that are serious about quality, I would estimate that around 30 per cent of infrastructure related investment could be directed towards automation, although that is only my personal estimate. What is clear is that the industry is investing far more in automation today than it did in the past. One of the drivers has been the increased focus on data integrity. 

Technology alone cannot guarantee data integrity—that ultimately depends on an organisation’s culture and values—but automation provides built-in controls that greatly strengthen compliance. 

Beyond compliance, digitisation improves efficiency and gives leaders immediate access to data for faster decision-making. It therefore delivers both operational benefits and stronger regulatory compliance. Geopolitical disruptions have repeatedly tested global pharma supply chains. How is Piramal Pharma building resilience and maintaining customer trust? Recent geopolitical developments—including the Red Sea disruptions, tariffs and ongoing conflicts—have certainly created challenges. In such an environment, the strength of a company’s supply chain becomes extremely important. 

Our vendor management network is quality driven, and our global footprint gives us significant flexibility. Because we operate across multiple geographies, we can source materials closer to individual manufacturing locations while also supporting sites in other regions whenever required. 

Our global presence also allows us to leverage local expertise. For example, if a supplier in the UK needs to be qualified for one of our India sites, our UK quality team can conduct the vendor audit rather than sending a team from India. This improves efficiency and responsiveness. 

Our supply chain, quality and manufacturing teams work very closely together, and we continuously monitor geopolitical developments so that we can take risk-based decisions early. That may include building inventory, securing alternate supplies or advancing shipments before disruptions occur. 

So far, we have been able to maintain reliable supplies for our customers, and we have not faced situations where customer commitments could not be fulfilled because materials were unavailable. 

When you talk about futureproofing quality systems and building future-ready teams, what would be your key message for pharma quality professionals? 

My message remains the same: quality is not a department—it is a commitment. 

You have to build quality on trust, not vigilance. Oversight will always be necessary, but vigilance alone cannot sustain quality. If people only do the right thing when someone is watching, the system will eventually fail. 

Every tablet we manufacture, every grain of API we produce and every vial we fill must meet the highest quality standards—not only during an inspection, but every single day.

That is why culture remains the foundation of everything we do. Quality must become part of how people think and work, not simply a compliance requirement.

 

 

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