Why Pharma Lags in Operational Excellence and How to Fix It

Explore the reasons behind pharma's lag in operational excellence and learn how companies can adopt best practices to boost efficiency, innovation, and quality.

#050: Operational Excellence in Pharma: Why the Industry Lags and How to Catch Up

Nagesh Nama

1.0. Introduction: Pharma’s Operational Excellence Gap

Pharmaceutical manufacturing is often called out for inefficiency and slow improvement. Despite being a high-tech industry in research, its production operations have notoriously lagged behind other sectors in productivity and innovation. For decades, drug makers enjoyed high margins and stable demand, which removed urgency to optimize plants. But times have changed – cost pressures, global competition, and rapid advances in digital and automation demand that pharma elevate its operational game. Yet progress remains slow.

Why does a highly regulated industry like pharma struggle to achieve the operational excellence seen in other equally regulated fields? This analysis examines the common excuses and deeper causes – from over-reliance on “compliance” to leadership blind spots and the quality assurance (QA) bottleneck – that have held pharma back. We also compare pharma’s performance to industries that have thrived under heavy regulation, and recommend how pharma can finally boost productivity, drive innovation, eliminate waste, and engage employees to close the gap.

2.0. The Compliance Excuse: Is Regulatory Oversight the True Barrier to Pharma Efficiency?

Ask pharma insiders why their processes are inefficient or slow to improve, and a common refrain is, “We’re heavily regulated – we can’t change easily.” It’s true that drug manufacturing follows strict good manufacturing practices (GMP) and is subject to extensive oversight to safeguard patient safety. A significant portion of time, roughly 30%, is dedicated to documentation, with biotech batch records requiring thousands of manual entries. Additionally, any adjustments to processes often trigger the need for re-validation and regulatory approval, causing delays and bureaucracy.

However, relying solely on regulations to explain inefficiencies doesn’t tell the full story. Many modern manufacturing techniques, including continuous manufacturing, have been established for decades and widely used in other industries, yet pharma has been slow to adopt these methods. As one expert noted, “In ‘Pharma Time,’ it can take 40–50 years to implement new technology.” Interestingly, the FDA has consistently encouraged innovation, making it clear that regulatory hurdles are not preventing the adoption of continuous manufacturing. In fact, the FDA has openly acknowledged that the pharmaceutical sector is lagging behind, and even challenged the industry to modernize in the next 25 years.

2.1. Is Regulation the Real Roadblock?

Industries with similarly stringent regulatory environments have demonstrated that efficiency and compliance can coexist. Take aerospace, for example. The sector is governed by strict regulations such as those from the FAA and DoD, and requires near-zero defects—much like the pharmaceutical industry. Despite these challenges, aerospace manufacturers adopted Lean manufacturing and continuous improvement methods in the late 20th century, achieving remarkable operational gains.

Similarly, the automotive industry, while subject to safety and environmental regulations, has pioneered some of the world’s most efficient manufacturing practices through methodologies like the Toyota Production System. These examples clearly demonstrate that meeting regulatory requirements and improving operational efficiency are not mutually exclusive.

2.2. Breaking Free from the Regulatory Comfort Zone

In reality, pharma’s reliance on regulation as an excuse often obscures deeper challenges—risk aversion, outdated thinking, and a lack of focus on operational innovation. According to an industry expert, pharma manufacturing is “far behind” in adopting modern practices, not solely due to regulations, but because of a comfort zone with the status quo and insufficient incentives for change. While compliance with regulations is crucial, it should act as a foundation, not a barrier. World-class operational performance is within reach for pharma as long as companies shift their mindset and embrace innovation.

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3.0. Leadership Failures: A Lack of Boldness and Expertise

If regulations aren't the primary issue, it's time to take a hard look at leadership and culture within pharma. For many years, senior executives within the pharmaceutical sector placed a higher emphasis on R&D and marketing, often neglecting manufacturing strategy. With high profit margins, inefficiencies went unnoticed, and little attention was given to process improvement or the introduction of new technologies. In the 1990s, when profits were at an all-time high, the focus on speed and cost-efficiency in operations was minimal, and no urgent need for change existed.

This complacency within leadership continues to hinder progress. Despite global competition and mounting pricing pressures, many pharma executives still fail to understand the value of modern operational methods. A 2018 report pointed out the lack of recognition for lean practices among senior leaders, leading to fragmented or unsuccessful lean initiatives. Without strong leadership vision and the commitment to implement change, operational improvements remain stagnated.

3.1. Risk Aversion: A Hindrance to Innovation

One of the greatest challenges to bold decision-making in pharma is risk aversion among leaders. While patient safety and regulatory compliance are top priorities, this cautiousness often stifles innovation. Roger Nosal, VP at Pfizer, has highlighted the tendency in the industry to resist change, preferring to maintain the status quo unless an innovation guarantees immediate, measurable benefits. This mindset causes pharma companies to stick with outdated equipment and traditional manual processes, leaving digital tools and advanced analytics unexplored.

An example of this is Pfizer's real-time quality release testing. The company introduced sensor-based technology to instantly assess product quality but eventually discontinued it due to high maintenance costs and the burden of regulatory filings. Instead of collaborating with regulators to adapt the approach, the innovation was abandoned, showing how leadership’s reluctance to take risks can stifle progress.

3.2. Learning from Other Industries

Industries like automotive manufacturing have demonstrated that with bold leadership, operational change is possible. In the 1980s and 1990s, automotive CEOs, facing competition from Japan, drove the adoption of lean manufacturing practices, significantly improving operational efficiency. The lesson for pharma is clear: only with committed and educated leadership can operational excellence be achieved. As a McKinsey report urged, today’s CEOs/COOs “may need to make bold changes to their operations strategy” for the company to remain resilient. That means moving beyond lip service to truly integrate productivity, quality, and innovation goals into the corporate vision. When leadership treats manufacturing as strategic – not as a back-office afterthought – organizations are empowered to take calculated risks and break the inertia.

4.0. Is QA a Roadblock? Shifting from Compliance Culture to Quality Culture

No exploration of pharmaceutical manufacturing inefficiencies is complete without addressing the role of Quality Assurance (QA). As the gatekeeper of product quality and patient safety, QA is essential. However, in many pharmaceutical organizations, QA has become a significant bottleneck, inadvertently stalling progress and innovation.

Despite “right-first-time” efforts, one of the most common causes of batch release delays is the QA review process. Manual record reviews, missing documentation, and repeated clarifications between QA and production can add days—or even weeks—to the process. With up to 30% of workforce time tied to documentation and compliance tasks, outdated QA practices significantly impact operational efficiency.

4.1. Compliance-Centric QA Culture: A Hidden Barrier

The challenge isn’t QA’s existence—its role is non-negotiable—but rather its approach and mindset. In many companies, QA operates with a compliance-first mentality, focusing on strict rule enforcement and paper-based perfection. This often results in resistance to change, with QA acting more as auditors than collaborative partners in quality improvement.

This mindset typically stems from limited operational exposure. Many QA professionals have deep knowledge of SOPs and regulatory guidelines but lack experience in continuous improvement or risk-based decision-making. Their interpretation of compliance can be rigid, missing the flexibility regulators actually allow.

As a result, QA teams often default to “no” when innovation is proposed—whether it’s digitizing batch records or implementing new technology—demanding extensive validation without considering the broader benefits. This excessive caution can stall initiatives and demotivate teams, reinforcing inefficiency instead of preventing it.

4.2. Modernizing QA: From Enforcer to Enabler

To unlock true operational agility, pharma companies must reframe QA as an enabler of compliant innovation. This begins with upskilling QA teams in areas like lean methodology, data analytics, and risk-based quality management. These skills empower QA staff to evaluate proposed changes more strategically—balancing compliance with process optimization.

A forward-thinking QA culture asks, “How can we do this compliantly?” rather than shutting down new ideas. Encouragingly, industry efforts like Quality by Design (QbD) and the FDA’s Quality Culture initiative are pushing companies toward building quality into processes from the ground up, supported by real-time data and science-based controls.

Top-performing organizations are already integrating QA into cross-functional continuous improvement teams, moving away from siloed quality departments. By enhancing the “regulatory and operational IQ” of QA personnel, companies reduce friction, improve speed, and maintain high standards of compliance.

4.3. Empowering QA to Drive Continuous Improvement

Quality Assurance should not be a barrier—it should be the catalyst for smarter, more agile processes. By investing in QA capabilities, fostering a collaborative mindset, and embracing modern quality frameworks, pharmaceutical manufacturers can transform QA into a key driver of efficiency, innovation, and regulatory excellence.

5.0. Lessons from Other Industries: What Pharma Can Learn

Pharmaceutical manufacturing often cites regulation as a barrier to progress—but several industries face similar or stricter compliance demands and still achieve world-class operational excellence. By comparing pharma with sectors like aerospace, automotive, and consumer goods, valuable lessons emerge on how to align regulatory compliance with efficiency and innovation.

5.1. Aerospace & Defense: Safety, Compliance, and Lean in Harmony

The Aerospace and Defense (A&D) industry operates under rigorous oversight—FAA regulations, military specifications (e.g., ITAR), and global quality standards like ISO/AS9100. Despite the high stakes (where failure can be catastrophic), A&D companies embraced Lean Manufacturing and Six Sigma in the 1990s–2000s to remain competitive.

Industry leaders like Boeing and Lockheed Martin adopted digital systems for real-time traceability, streamlined production, and built a culture of first-time-right quality. By embedding compliance into operational workflows, they proved that stringent regulation doesn't have to slow down progress. Their experience shows that with leadership commitment, it’s possible to meet quality and safety standards while continuously improving.

Key takeaway for pharma: Compliance and efficiency can coexist when digital systems, culture change, and continuous improvement become strategic priorities.

5.2. Automotive: When Pressure Sparks Performance

The automotive industry, long subject to strict safety and environmental regulations, faced a wake-up call in the 1980s with the rise of Japanese lean production. U.S. automakers responded by embracing the Toyota Production System (TPS)—focusing on waste elimination, automation, and built-in quality.

Today, automotive plants lead in inventory turnover, a critical metric for operational agility. While pharma averages only 1–2 inventory turns per year, auto manufacturers achieve 10–20+. Their success was driven by empowering plant-level decision-making, automating intelligently, and embedding operational excellence into the business model.

Key takeaway for pharma: External pressure (like pricing and generics) should be a catalyst for transformation—not an excuse for delay.

5.3. Food, Consumer Goods, and Even Nuclear Energy: Excellence Amid Oversight

Food and beverage manufacturers face FDA/USDA scrutiny, while consumer goods giants like Nestlé and Unilever manage global supply chains under diverse regulatory environments. These sectors have adopted lean tools, HACCP systems, and digital monitoring to enhance safety and efficiency.

Even nuclear power plants, arguably the most regulated environments in existence, use structured operational excellence frameworks to achieve remarkable reliability and safety. Consumer electronics manufacturers, though less regulated, thrive under extreme innovation pressure—mastering fast production cycles and agile quality systems.

Key takeaway for pharma: Regulation should be the baseline, not a ceiling. Culture, training, and data-driven systems enable both compliance and innovation.

5.4. Successes and Setbacks Within Pharma: Mixed Signals

Some pharmaceutical companies are making progress. Amgen improved its inventory turns by over 6.5% annually since 2009, translating lean improvements into financial gains. The mRNA vaccine scale-up during COVID-19 showed how regulatory agility and innovation can coexist when urgency is high and leadership is fully committed.

However, many lean efforts have fizzled. Programs like “Merck Sigma” and similar Lean Six Sigma initiatives at top pharma firms started strong but lost steam. Often viewed as short-term quality projects instead of enterprise-wide strategies, these efforts lacked sustained leadership and cross-functional integration.

A common issue? Deploying tools in silos—one site or one team—without aligning culture, metrics, and leadership incentives. As a result, initial wins didn’t scale or stick.

5.5. Pharma Must Close the Performance Gap

Other industries show that stringent compliance and operational excellence are not mutually exclusive. Pharma can catch up—but only by:

Treating manufacturing as strategic, not secondary
Investing in cross-functional training and data systems
Embedding continuous improvement into company culture
Aligning leadership around productivity, compliance, and innovation goals

The challenge now is not in knowing what to do—but in committing fully to the transformation. The pharma sector’s next leap will come not from isolated pilots, but from enterprise-wide adoption of proven operational excellence principles.

6.0. Data and Benchmarks: Pharma’s Operational Gap by the Numbers

To truly understand the performance gap in pharmaceutical operations, we need to look at the numbers—and they paint a sobering picture. Compared to other industries, pharma manufacturing lags behind in productivity, efficiency, and innovation adoption, despite being a high-margin, high-stakes sector.

6.1. Labor Productivity: The Slowest Climb

Between 1987 and 2008—a span of over two decades—labor productivity in U.S. pharmaceutical manufacturing grew at an annual rate of just 0.7%, according to Bureau of Labor Statistics data. That’s less than one-third the growth rate of general manufacturing over the same period.

While other industries embraced automation, lean manufacturing, and digital tools to double or triple output per worker, pharma made only marginal gains. The result: a widening gap in competitiveness and agility.

6.2. Asset Utilization: Low Equipment Effectiveness

Another critical measure is Overall Equipment Effectiveness (OEE)—the percentage of time that production equipment is truly adding value. Pharma’s average OEE hovers around 35%, according to McKinsey, meaning facilities are idle or stopped nearly two-thirds of the time. In comparison, automotive manufacturers regularly exceed 80% OEE, reflecting tightly managed operations and continuous flow.

This underutilization drives up costs and limits responsiveness, especially in an era where supply chain agility is becoming a competitive advantage.

6.3. Inventory Turnover: Pharma Still a Laggard

As mentioned previously, inventory turnover in pharma—a key metric of operational agility—is among the worst in any sector. While best-in-class industries like electronics or consumer goods turn over inventory every few weeks, pharma often holds 6 to 8 months of stock. This ties up working capital and masks inefficiencies in production planning and quality assurance.

6.4. Innovation and Technology Adoption: Behind the Curve

Technological adoption tells a similar story. Continuous manufacturing, a hallmark of efficiency in chemicals and petrochemicals, has barely penetrated pharma. The first FDA-approved continuous tablet manufacturing line only arrived in the mid-2010s.

In surveys conducted by ISPE and other industry bodies, pharma ranks behind automotive, electronics, and even consumer packaged goods in deploying Industry 4.0 technologies—like advanced robotics, IoT-connected equipment, real-time analytics, and digital twins. The industry's fragmented systems and conservative change culture often delay widespread implementation.

6.5. Employee Experience: High Pay, Low Empowerment

On the surface, employee satisfaction in pharma is relatively high. A Glassdoor review found pharma ranked #1 for satisfaction with compensation and benefits. Many employees also find meaning in the work, driven by the mission of helping patients.

But high pay doesn't guarantee high engagement in daily operations. Anecdotally, many plant-floor workers report frustration with rigid SOPs, bureaucratic procedures, and a lack of autonomy: “It’s in the SOP—just follow it.” This procedural rigidity limits frontline innovation and undermines morale.

By contrast, companies known for operational excellence—in sectors like automotive or aerospace—actively engage workers at all levels. These firms create systems where employees can suggest improvements, solve problems independently, and take ownership of both quality and efficiency.

6.6. Big Numbers, Bigger Opportunity

The data is clear: pharma significantly underperforms on key operational metrics—productivity, equipment use, inventory turnover, and tech adoption. But this also means the opportunity for transformation is enormous.

By learning from other industries and unleashing the full potential of its workforce, pharma can close the gap. Investing in real-time data systems, cross-functional training, and a culture of empowerment isn’t just about efficiency—it’s about resilience, agility, and better outcomes for patients.

7.0. Overcoming the Challenges: A Practical Path Forward for Pharma Operations

Pharma can no longer afford to trail behind its peers when it comes to operational performance. The traditional safety net of high margins and limited competition is rapidly eroding. Today, both economic pressure and regulatory expectations demand a new playbook—one that prioritizes productivity, innovation, and employee engagement.

The excuses are known, the structural issues understood. What’s needed now is action. Here’s a six-part strategy to help pharmaceutical manufacturers leap forward—not incrementally, but decisively.

7.1. Operational Excellence Must Be a Boardroom Priority

‍To drive real change, operational excellence needs the same strategic attention as R&D and commercial growth. That means C-suite ownership, dedicated resources, and regular executive focus on key performance indicators like OEE, yield, cycle time, and inventory turns.

Set bold goals—“double our asset utilization by 2025” or “cut batch release time in half”—and back them with the budget, technology, and leadership needed to deliver. Consider appointing a Chief Operational Excellence Officer or elevating operations leadership to the executive team.

When productivity and quality improvement are treated as core to the company’s mission—not side projects—progress becomes inevitable.

7.2. Build a Leadership Team Fluent in Modern Operations

‍The next generation of pharma leaders must be equally comfortable talking about clinical pipelines and robotic batch release. Invest in leadership development programs that combine operational expertise, compliance knowledge, and digital literacy.

Bring in seasoned experts from outside industries to challenge status quo thinking—but also focus on upskilling your existing team. Encourage rotations through manufacturing, QA, and supply chain roles. Host site visits to other sectors. Provide hands-on exposure to AI tools, advanced automation, and quality data systems.

When leadership truly understands both the technical and regulatory levers of change, they’re empowered to act—and far less likely to accept “we’re regulated” as a permanent constraint.

7.3. Redefine Quality Assurance as a Driver, Not a Drag

‍Quality can be both compliant and fast—but only if QA shifts from a gatekeeper mindset to a partnership model.

Start by embedding quality professionals into improvement teams. Train them in lean thinking, Six Sigma, and risk-based quality management. Implement real-time release strategies and Quality by Design so QA ensures process robustness rather than catching issues downstream.

Leverage digital systems—electronic batch records, automated deviation tracking, and real-time dashboards—to reduce manual work and improve transparency. Measure QA not just by audit outcomes, but also by efficiency metrics like document cycle time and first-pass success.

The goal: quality as an enabler, not a bottleneck. That’s not just possible—it’s what modern regulators increasingly expect.

7.4. Go All-In on Digital and Automation Tools

‍The pharma digital gap is real—and costly. To close it, companies must aggressively adopt proven technologies from other sectors:

Automate manual processes with robotics and machine learning.
Use IoT sensors and real-time analytics for tighter process control.
Digitize workflows across the supply chain for visibility and agility.
Deploy AI-powered schedulers to optimize batch timing and resource use.

Crucially, involve regulators early. Collaborate with FDA’s Emerging Technology Program or EMA’s Innovation Task Force. Show them the science and control behind the tech—many are ready to approve novel methods that improve quality and speed.

Digital transformation is not a luxury—it’s how pharma regains operational leadership.

7.5. Build a Culture of Daily Continuous Improvement

‍Technology alone won’t drive lasting change. What sustains operational excellence is a workforce that’s engaged, empowered, and always improving.

Train all employees—from line operators to QA reviewers—in basic problem-solving, lean tools, and waste identification. Set up daily huddles, Kaizen boards, and structured idea pipelines so staff can raise issues and implement fixes without red tape or fear of blame.

Shift the mindset from “deviation equals error” to “deviation equals opportunity to improve.” Recognize and reward contributions that make the system better. Conduct gemba walks so leaders stay close to frontline reality. Make improvement KPIs part of every department’s dashboard.

Companies like Pfizer and Novartis have seen real success by embedding these practices. The result? Faster operations, fewer errors, and happier employees.

7.6. Collaborate with Regulators and Learn from Other Industries

‍Leading pharma companies don’t treat regulators as roadblocks—they treat them as partners in modernization.

Invite FDA or EMA representatives to tour your advanced manufacturing lines. Share data that shows how new methods maintain or enhance quality. Participate in pilot programs. Shape evolving guidance on quality maturity and digital validation.

At the same time, benchmark aggressively outside the industry. Visit high-performing auto plants, food packaging lines, or semiconductor fabs. See how others manage speed, quality, and control under pressure. Borrow what works. Innovate within the rules.

The truth is, most operational challenges pharma faces have already been solved—somewhere else. Don’t reinvent the wheel. Adapt and scale what’s proven, and bring regulators along for the ride.

8.0. Conclusion: No More Excuses – It's Time for Pharma to Lead

Pharma’s mission—to deliver safe, effective therapies—will always demand vigilance and care. But careful doesn’t have to mean slow, bloated, or inefficient. The chronic gap between pharma and other industries in operational excellence isn’t due to some regulatory law of gravity. It’s the result of outdated mindsets, organizational silos, and risk-averse cultures that have gone unchallenged for too long.

That era must end.

Today, the stakes—both competitive and clinical—are simply too high for business-as-usual. Companies can no longer afford leadership teams disconnected from daily operations, quality organizations that say “no” by default, or cultures that treat compliance and efficiency as mutually exclusive. The good news? There’s a better way—and the roadmap is clear.

Pharma doesn’t have to reinvent the wheel. Other regulated industries have already paved the path—proving it's possible to deliver precision, speed, and safety all at once. By embracing those lessons, pharmaceutical manufacturers can modernize without compromising patient safety. In fact, they can do both better.

That means:

Elevating operations to a board-level priority
Bridging the leadership gap in technical and regulatory fluency
Transforming QA into a partner for innovation, not a barrier
Harnessing automation, data, and AI for smarter, faster decision-making
Empowering frontline employees as agents of change

These aren’t hypothetical strategies—they’re proven, practical steps that pharma can take today.

8.1. A Vision Worth Building

The next decade should be pharma’s operational renaissance. Imagine:

Digital batch records and “no-touch” documentation, enabling real-time release with zero rework.
Predictive AI supply chains, eliminating shortages while shrinking inventory buffers.
High-morale teams, proud not just of the product but of the process that delivers it.
Facilities running at world-class OEE, with near-perfect right-first-time rates and no backlogs.

This isn’t science fiction. These capabilities already exist—in other industries, and in the few pharma pioneers willing to challenge the norm.

The only thing missing now is willpower.

8.2. The Choice Is Clear

Pharma has everything to gain from shedding its legacy of slow-moving operations: faster time to market, lower costs, fewer errors, greater agility, and better outcomes for patients. What it needs now is the courage to break from the past and build something better.

The companies that seize this moment—those that reject excuses, transform their culture, and treat operational excellence as mission-critical—will not only leap ahead of their competitors. They’ll redefine what good looks like in global healthcare.

The prescription has been written. The tools are ready. The time is now.

Bridge the gap between compliance and efficiency—Contact Us Today

9.0. Sources

McKinsey & Company – “Operations can launch the next blockbuster in pharma” (2019): Highlights how pharma’s systems and capabilities lag behind other industries, with ~30% of staff time spent on documentation and QA being the biggest source of batch release delays (Operations can launch the next blockbuster in pharma | McKinsey) (Operations can launch the next blockbuster in pharma | McKinsey).
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Pharma Manufacturing – “The Other Path to Productivity Improvement” (2013): Reports that from 1987–2008, labor productivity in U.S. pharma manufacturing grew only 0.7% annually, the lowest of any industry (vs. ~2.3% average) (Process Innovation, August: The Other Path to Productivity Improvement: Pharmaceutical Manufacturing | Pharma Manufacturing). Notes pharma’s failure to control costs via lean methods that other sectors use.
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Leading Edge Group – “6 Challenges in Managing Lean in a GMP Environment” (2021): Describes common issues in pharma such as over-focus on compliance rather than process improvement, heavy bureaucracy for changes, siloed departments, and lack of lean culture, noting that including QA/Regulatory in improvement projects is essential (The 6 Challenges in managing a Lean Sigma initiative in a GMP Environment - Leading Edge Group) (The 6 Challenges in managing a Lean Sigma initiative in a GMP Environment - Leading Edge Group).
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National Academies Workshop – “Barriers to Innovations in Pharmaceutical Manufacturing” (2020): FDA’s Michael Kopcha identified regulatory, technical, and financial barriers – including inflexible operations/management thinking – that hinder manufacturing innovation (Barriers to Innovations in Pharmaceutical Manufacturing Proceeding of a Workshop—in Brief - Innovations in Pharmaceutical Manufacturing on the Horizon - NCBI Bookshelf) (Barriers to Innovations in Pharmaceutical Manufacturing Proceeding of a Workshop—in Brief - Innovations in Pharmaceutical Manufacturing on the Horizon - NCBI Bookshelf). Pfizer’s Roger Nosal discussed how expanding regulatory requirements (30% increase in CMC content in 20 years) often just “checks boxes” without improving quality, and noted both industry and FDA’s risk aversion stifles change (Barriers to Innovations in Pharmaceutical Manufacturing Proceeding of a Workshop—in Brief - Innovations in Pharmaceutical Manufacturing on the Horizon - NCBI Bookshelf) (Barriers to Innovations in Pharmaceutical Manufacturing Proceeding of a Workshop—in Brief - Innovations in Pharmaceutical Manufacturing on the Horizon - NCBI Bookshelf). Example: Pfizer abandoned real-time release testing for 7 products due to burdensome post-approval change filings, which negated the business case (Barriers to Innovations in Pharmaceutical Manufacturing Proceeding of a Workshop—in Brief - Innovations in Pharmaceutical Manufacturing on the Horizon - NCBI Bookshelf).
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PharmTech – “Reinventing Lean Six Sigma for the Pharmaceutical Industry” (2017): Recalls that Merck, J&J and others enthusiastically adopted Lean Six Sigma (LSS) in the 2000s, but a decade later enterprise-wide programs became “muted,” limited to small-scale initiatives (Reinventing Lean Six Sigma for the Pharmaceutical Industry). Cites misunderstandings (viewing LSS as just training or narrow quality tool) and failure to integrate with business strategy as reasons LSS didn’t become standard in pharma (Reinventing Lean Six Sigma for the Pharmaceutical Industry). Emphasizes the need for senior management support and relevance to business goals for LSS to succeed.
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Pharma Manufacturing – “Lean Laggards: State of Lean in Pharma” (2018): Finds that despite numerous case studies and efforts, little overall progress has been made industry-wide – inventory turns remained flat over 5–10 years, and recent performance lagged the prior decade (Lean Laggards: Exploring the State of Lean in Pharma | Pharma Manufacturing) (Lean Laggards: Exploring the State of Lean in Pharma | Pharma Manufacturing). Concludes that gains haven’t been sustainable due to lack of senior leadership understanding and commitment to lean (Lean Laggards: Exploring the State of Lean in Pharma | Pharma Manufacturing). Notes pharma was a late lean adopter due to no burning platform in high-margin years (Lean Laggards: Exploring the State of Lean in Pharma | Pharma Manufacturing). Even top early adopters (like AstraZeneca) plateaued or regressed, and pharma still ranks near the bottom of industries in lean metrics like inventory turns (Lean Laggards: Exploring the State of Lean in Pharma | Pharma Manufacturing). Highlights Amgen as a positive outlier with a 6.5% annual improvement in inventory turns since 2009 (Lean Laggards: Exploring the State of Lean in Pharma | Pharma Manufacturing).
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PharmOutsourcing – “Implementing New Technologies in a Regulated Environment” (2013): Quotes FDA officials stating there are “no regulatory hurdles” to modernizing (continuous manufacturing) and that current pharma processes would be recognized by 1950s experts ( Implementing New Technologies in a Regulated Environment | Pharmaceutical Outsourcing - The Journal of Pharmaceutical & Biopharmaceutical Contract Services ). Observes that many “new” technologies for pharma (continuous processing, PAT, etc.) have existed for decades and been used in other industries; pharma’s adoption is painfully slow and “one cannot always blame regulatory bodies” for the 40-50 year lag ( Implementing New Technologies in a Regulated Environment | Pharmaceutical Outsourcing - The Journal of Pharmaceutical & Biopharmaceutical Contract Services ).
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Ease.io – “Lean Principles for Aerospace Manufacturers” (2020): Affirms that lean has been successfully applied in aerospace, a high-precision, highly regulated industry. Notes that aerospace has “myriad government regulations” and requires extreme quality (akin to healthcare where “close enough” isn’t acceptable) (Core Lean Manufacturing Principles for Aerospace Manufacturers | Ease.io), yet lean manufacturing is viable and widely adopted in that sector (Core Lean Manufacturing Principles for Aerospace Manufacturers | Ease.io). Demonstrates that regulation did not prevent aerospace from eliminating waste and improving flow.
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McKinsey & Company – “Emerging from disruption: Future of pharma operations” (2022): Emphasizes the need for pharma CEOs and COOs to make bold, long-term operations strategy choices in light of challenges (COVID-19, new therapies, inflation) (Six new pharmaceutical industry trends | McKinsey). Acknowledges that in the past many pharmas de-prioritized operations strategy, but now resilience depends on operational excellence (Six new pharmaceutical industry trends | McKinsey). Suggests a shift from continuous firefighting to strategic capability-building, driven by top leadership.
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Pharma Manufacturing – “Process Innovation: The Other Path…” (2013): Discusses rising pressure on pharma manufacturing (costs up, prices down, supply chain complexity) and how returns on R&D are falling (Process Innovation, August: The Other Path to Productivity Improvement: Pharmaceutical Manufacturing | Pharma Manufacturing) (Process Innovation, August: The Other Path to Productivity Improvement: Pharmaceutical Manufacturing | Pharma Manufacturing). Argues pharma must transform productivity and cites an emerging set of disruptive innovations (e.g. fully integrated continuous lines) that promise huge gains (Process Innovation, August: The Other Path to Productivity Improvement: Pharmaceutical Manufacturing | Pharma Manufacturing) (Process Innovation, August: The Other Path to Productivity Improvement: Pharmaceutical Manufacturing | Pharma Manufacturing). Stresses that winners will be those who invest in game-changing ops innovations, not just new drugs.