What motivated you to write Quality Trailblazer, and how does it address the most pressing quality challenges faced by the Indian and global pharma industry today?
I wrote this book to express myself—to reflect on what I did, what I learned, and how those experiences shaped me. More importantly, I hope that by documenting this path, someone somewhere— perhaps a student just stepping into the world of pharma, a young professional grappling with early challenges, or even a seasoned expert looking for perspective—may find value, insight, or even a moment of clarity.
The pharmaceutical industry has seen many waves of change (Pharma 3.0 to Pharma 4.0), and I’ve had the privilege of witnessing them all—from the days when ‘quality’ was largely about control, to the present, where ‘assurance’ has become the cornerstone.
Through this book, I share not only milestones and experiences but also the core values that have consistently guided me are:
- There is no alternative to working hard and working smart
- There is no alternative to gaining knowledge
- There is no alternative to teamwork
- There is no alternative to being honest
These principles are timeless. They do not just belong to the quality sphere— they belong to life itself.
This is my first book and I sincerely hope this book serves not only as a guide but also as a source of motivation and empowerment for all who read it.
Through real experiences, case studies, and actionable frameworks, Quality Trailblazer provides a roadmap for adopting risk based thinking, building a culture of ownership, strengthening systems, and aligning Indian pharma with global expectations.
Ultimately, the book is a call to work for HIGH QUALITY with focus on Patients, from a function to a shared value, enabling organisations not only to meet global standards but to set them.
You’ve had a long and diverse career in the global pharmaceutical and regulatory landscape. How does your personal journey reflect in the chapters of this book?
Each chapter reflects a phase of my career: the early years where I learned the fundamentals of discipline and GMP at Pfizer; the middle years marked by global exposure, cross-cultural experiences, regulatory expectations at Lyka Labs & Ranbaxy days; and the later years days, where consulting allowed me to see patterns, gaps, and opportunities across the industry.
This my Quality Trailblazer is a lived narrative—sharing principles, failures, breakthroughs, and leadership insights that shaped my thinking. The chapters are intentionally practical, mirroring the challenges, decisions, and transformations I witnessed firsthand. In essence, the book is both a professional reflection and a personal roadmap, capturing what five decades in pharma have taught me about quality, people, and purpose.
What are the top three challenges you observe in pharma quality systems, and how does Quality Trailblazer propose organisations to overcome them?
The top three challenges I observe in pharma quality systems are: weak data integrity practices that stem from cultural barriers, lack of training, and pressure-driven operations; inconsistent quality culture, where quality is seen as a departmental responsibility rather than a shared organisational value; and gaps in risk-based decision-making, leading to reactive compliance instead of preventive, science-driven quality.
Which insights from your book are particularly relevant for Indian companies aiming to strengthen their regulatory standing?
Indian companies must shift from reactive problem-solving to proactive risk anticipation, embedding Quality by Design, robust Data Integrity practices, and implementing various AI technologies to speed up the Operations with additional benefit of cost savings by way of enhancing productivity, in same time with same equipment & using saved human hours for High Patient focused Quality & Safety.
Another crucial learning is the importance of global mindset. Quality should not vary by market, and every batch must meet the highest international standard regardless of destination. Strengthening regulatory standing also requires transparent communication, strong supplier governance, continuous training, and adoption of digital tools that bring visibility and control to operations.
The book Quality Trailblazer emphasises that leadership commitment is non-negotiable: when leaders walk the shop floor, ask the right questions, reward ethical behaviour, and challenge shortcuts, the organisation rises to global expectations.
Ultimately, the message is simple yet powerful—Quality is not a cost but a competitive advantage, and companies that embed this philosophy will not only meet regulatory expectations but also build lasting trust and global respect. The cost of noncompliance is higher than quality compliance.
In the book, you highlight Quality Culture as the backbone of sustainable excellence. What practical steps can companies take to build and measure a true quality culture?
A true quality culture is built on everyday behaviours, not only policies. Companies must begin by setting a clear tone from the top leaders who visibly prioritise GMP, data integrity, and patient safety to establish the cultural baseline.
Embedding quality into daily work through simple, standardised routines, Gemba walks, open reporting, right first-time practices, and cross functional quality ownership creates consistency.
Capability-building is equally essential: practical training, coaching at the shop floor, and empowering teams to pause operations when something feels wrong. Transparent communication, learning from near-misses, and celebrating quality positive behaviours reinforce the culture. Measurement must go beyond traditional KPIs. Companies should track leading indicators like CAPA effectiveness, right-first-time trends, audit observation recurrence, employee speakup rates, deviation-to-batch ratio, and quality maturity assessments.
Regular cultural diagnostics—surveys, behavioural observations, and leadership engagement scores—offer deeper insight into mindsets. When companies align values, behaviours, and accountability with the shared purpose of protecting patients, quality culture becomes self-sustaining and drives long-term excellence.
Could you share a real case or learning that significantly shaped your understanding of quality excellence?
One of the most defining learnings in my five decades came early in my career, during an investigation of a recurring contamination issue in a sterile facility. As mentioned in my book “Quality Trailblazer”, there was an incidence of market complaints from the US Market of broken tablets, which taught us that each & every change, major or minor, must be recorded for right Root cause analysis & CAPA.
Such experiences shaped my entire philosophy of quality. It taught me that quality is never built in documents—it is built in behaviours. True excellence demands leaders who listen, who go to the real place, who respect those doing the work, and who create an environment where people feel responsible, not supervised.
Some of the most enduring lessons I’ve learnt along this journey are to:
- Stay calm and composed in the face of challenges.
- Be patient and selflessly help others.
- Continuously adapt to new technologies and enhance your expertise.
- Embrace lifelong learning from Continuous Manufacturing to Process Analytical Technology and even exploring Artificial Intelligence in recent years.
- Without adequate knowledge, we can’t survive in this knowledge-based Pharma industry.
- Stay with the TIME.
- Effective leadership is characterised by vision, integrity, empathy, & decisiveness.
Over the years, this insight became a foundation of how I approached audits, training, culture building, and later, how I mentor leaders: systems can fail, machines can err, but a committed and informed workforce rarely does.
swati.rana@expressindia.com
Swatirana.express@gmail.com