Trend Brief
2023 Pharma
Manufacturing Trends
What Is the Future of the Pharma
Manufacturing Industry?
If we could predict the future of the pharma manufacturing
industry, we wouldn’t have been rattled by supply disruptions
throughout the pandemic. And we would’ve been able to
anticipate which products would unexpectedly experience
weak demand. At the very least, we could’ve predicted which
winning therapies to invest in! So why do we waste time trying
to predict future conditions when we could be preparing for
them? Wishing for a crystal ball is a distraction when you have
real opportunities today to start building for tomorrow. It’s time
to control the things that are within your power to control and
take advantage of technologies that will help you tackle the
challenges of today while forging — not trying to predict — the
industry’s future.
Although the future will always be unpredictable, the latest
biotech and pharma manufacturing trends all share an
underlying theme: adaptability. It’s the key to persevering in
uncertain, ultra-competitive times. To develop adaptability
at the individual company level, pharma manufacturers find
themselves needing to be “more focused on operational
resilience and accelerating initiatives that enable more agility —
including workforce agility as workforces become more remote
and distributed — and transparency through greater deployment
of digital and analytics tools and automation,” according to
McKinsey’s latest industry findings.1
If adaptability, versatility, and agility are the keys to survival in
a competitive and evolving industry, advanced technologies are
the definitive means by which pharma manufacturers can make
it a reality. The trends featured in this brief reveal opportunities
for pharma manufacturers to become more adaptable and
highlight various ways that modern digital tools can help them
realize that adaptability.
1
Enhancing Visibility
With Supplier
Management Solutions
If the COVID-19 pandemic’s ripple effects
didn’t directly disrupt your supply chain,
at the very least, they opened your eyes
to how fragile supply chains can be and
how quickly they can devolve into chaos.
A business is only as strong as its
chain of suppliers, and the pandemic
highlighted the need to transform
traditional supply chain models.”
– Deloitte2
The uncertainty of the pharma industry’s new normal
has manufacturers clamoring for greater control over,
predictability of, and visibility into their supply chains. For
some that means shortening or building redundancies into
their supply chains. For others, it may mean onshoring or
reshoring, which seven out of 10 life sciences companies
recently surveyed by Axendia indicated they are considering
in the near future.3
A noteworthy pharma manufacturing trend that’s gaining
momentum as a countermeasure to supply uncertainties is
the development of supply chain command centers. While
Trend Brief
the term “command center” may conjure images of air
traffic control towers or military headquarters, in pharma
environments it can be something as straightforward as “a
tool consisting of existing and new technologies combined
with near-real-time data from the business ecosystem,”
according to Gartner.5
Centralization and connectivity are the two critical
elements of a high-functioning and effective command
center. To achieve both, a purpose-built software solution
that integrates production, quality, and supplier-related
processes forms the ideal foundation for a command center.
Digital supplier management solutions offer the connectivity
and flexibility that enables pharma manufacturers to
transform linearly sequenced supply chains into an
interconnected, optimized, and more dynamic system.
There’s a global trend built
on rethinking the global supply
chain, including reshoring, building
redundancies in suppliers, rethinking
logistics and updating systems and
processes to ensure that stocks are
readily available.”
– Stuart Needleman, Piramal Pharma Solutions CCO4
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 Trend Brief

A command center rooted in a robust supplier management

software solution can be the cornerstone you need to
develop a resilient supply chain strategy. It provides a hub
through which end-to-end (E2E) visibility can be enhanced
through digitization. Pharma manufacturers who embrace
the command center model as a means of enhancing
visibility would be wise to structure it around the four
competency areas Deloitte has identified as vital pillars:
1 Develop forward-sensing abilities to improve
demand prediction.
2
Leverage analytics.
3 Increase data sharing and transparency with
customers and partners.
Many supply chain leaders struggle
to identify what is most important and
what are the best actions to take. …
Supply chain command centers can
help supply chain leaders connect
domain-centric data and systems/tools
to gain additional, connected insights
and recommendations by leveraging a
digital supply chain twin, augmented
analytics and decision intelligence
capabilities.”6
– Gartner

4 Explore opportunities to harvest cutting-edge

technologies.7
Top 3 Biggest Threats to Supply Chains
A command center built on a connected supplier as reported by life sciences manufacturers
management software solution can serve as the focal point

60% 50%
through which visibility enhancements like these can be
achieved and resiliency can be mastered.
Delays in incoming
materials

33%
Staying ahead of
process disruptions

Communication
(with internal
and/or external
partners)

– Axendia8

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 Trend Brief

Theoretical to practical:
Take steps toward modernization
By 2023, 50% of global
1 Embrace Purpose-Built Supplier
Management Solutions: product-centric enterprises will
The thought of establishing a supply chain command have invested in real-time visibility
center may seem daunting or unachievable to most
platforms. These solutions will help
pharma manufacturers. But it can be as simple as
identifying a supplier management software tool that manufacturers predict the future
will keep your data connected across the supply chain of their supply chains, rather than
and give you access to supplier information in real
simply reacting to disruptions as
time. With a proven supplier management software
solution, pharma manufacturers can gain greater they occur.”9
visibility into and align quality across their networks – The Pharmaceutical Supply Chain: Closing the Visibility Gap survey
of approved suppliers.

2 Revamp Your Approach to Supplier Risk

Management:
In a study on extended enterprise risk management
(EERM), Deloitte found that 85% of organizations do
We all think we’re nimble until
not develop the appropriate capability and capacity to we discover we’re not. I realize we
manage the entire spectrum of third-party risks, in an don’t want to spend all of our energy
integrated and holistic manner, across all the parties
in their ecosystems.11 By that math, only 15% of
solving the last crisis. But I think that
pharma manufacturers are integrating or optimizing the last crisis being COVID is going
their approach to supplier risk management — a to be replicated in whatever the next
problem that could be eliminated with an effective
supplier management software solution.
crisis is. I think we would be well
advised to devote time, energy, and
3 Develop a Resilient Supply Chain Strategy:
investment to the durability of our
In today’s pharma manufacturing supply chains, supply chain.”10
resiliency has even greater value than efficiency.
– Winn Thurlow, MedTech Executive Director
And E2E visibility is central to the development of
a resilient supply chain. The most practical way
to achieve it is through digitization. According to
Deloitte’s best-practice strategies for building
resilient supply chains, supplier management
solutions can be beneficial in providing not only
supply chain visibility, but also prescriptive risk
management, continuous monitoring functionality,
and improved issue and risk identification.12

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2
Realizing Total Quality
Management Through
Enhanced Connectivity
What Is TQM in Pharma?
Total Quality Management (TQM) is a widely
applied philosophy and business approach
that involves all individuals within an
organization participating collaboratively
in continuous quality improvement efforts.
Pharma manufacturers that embrace a
TQM approach value the highest levels of
production performance and focus efforts
on minimizing waste, if not eliminating
it altogether. An integrated system is
essential for embedding TQM practices into
every aspect of a pharma manufacturer’s
operations. Experienced software vendors
have engineered purpose-built solutions
based on the TQM principles set forth in
quality standards and regulations.
Trend Brief
Manufacturing professionals may
cringe every time the dreaded Q-word is
uttered, but we all must recognize that
quality is a vital element that should
exist within the manufacturing system
rather than outside of it.
Too many painful lessons have been learned when
circumstances force pharma manufacturers to spend more
time and effort fixing problems rather than preventing them
from occurring in the first place. The old saying (and unofficial
TQM motto) is true — an ounce of prevention is worth a
pound of cure. As a proactive quality strategy that focuses
on avoiding issues that could jeopardize a product’s ability
to meet or exceed customer expectations, TQM is beneficial
in all manufacturing settings. In pharma manufacturing, it’s
also a key tactic for adhering to good manufacturing practice
(GMP) regulatory requirements, avoiding drug shortages, and
ensuring product and patient safety.
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 Trend Brief

The classic approach to TQM is based on the four-phase Meeting these TQM goals is contingent on developing a
“PDCA” cycle: culture of quality that underpins an organization’s every
process, system, and person. But a culture of quality
1. Plan ways to overcome an existing challenge.
doesn’t occur organically — it requires a concerted effort
2. Do an evaluation of the problem and propose a solution. by everyone involved. A strong quality culture is a sign of
3. Check the effectiveness of the process fix. quality management maturity (QMM), the state pharma
4. Act by documenting results and preparing to address manufacturers attain by having consistent, reliable, and
other problems.13 robust business processes that enable them to achieve
quality objectives and promote continual improvement.
Manufacturers typically adopt one of several proven TQM Quality maturity is becoming so vital, in fact, that the U.S.
models to execute the PDCA cycle. Perhaps you’ve heard of Food and Drug Administration (FDA) is developing a QMM
(or even had applied within your organization) the Deming rating system to incentivize drug manufacturers to invest
Application Prize or European Foundation for Quality in it.14
Management or similar methodology. Regardless of whether
a specific model is employed, all TQM efforts in pharma
manufacturing revolve around eight fundamental objectives:
TQM BENEFITS
1. Produce a high-quality product and make it right the
first time.
2. Maintain a focus on customer safety and satisfaction.
Greater Higher
3. Integrate processes, systems, and people. Customer Productivity
4. Improve quality metrics by involving all employees Satisfaction and Morale
at the appropriate level.
5. Establish a TQM strategy and ensure it is communicated
Reduced Fewer
to the right stakeholders. Overall Product
6. Measure the key performance indicators (KPIs) that Costs Recalls
matter most.
7. Make data-driven decisions.
8. Focus on the ultimate goal of continuous improvement
and establish processes that facilitate it.

6

The greatest difficulty in applying TQM principles across the
entire organization is first getting everyone — from the upper
levels of the C-suite to the line workers on the production
floor — to buy in and commit to making continuous quality-
minded efforts that result in customer satisfaction and
loyalty. Every employee must be working to improve the
culture, processes, and systems that breed long-term
success. But getting everyone in sync requires the right set
of tools.
Advanced TQM software solutions provide the connectivity
needed to bridge the gaps between people, processes, and
systems. The infrastructure of a common TQM platform
inherently embeds quality into production processes and
makes it more visible in every aspect of operations. Plus, it
allows organizations to put real-time data into the hands
of those who need it to do their jobs correctly and make
sound decisions.
Theoretical to practical:
Harmonize production and
quality processes
1 Eliminate paper to streamline production:
Manual, paper-based processes are the leading cause
of inefficiencies that result in production setbacks,
long lead times, and delayed product releases. When
you ditch paper and adopt a fully digital solution,
you forge productive links between personnel,
data sources, enterprise systems, and quality and
production processes.
Quality improvements gained by manufacturers who fully digitized production:
90%-100% 75%-80% 21%
decrease in data input errors. faster record reviews and
product releases.
Trend Brief
Strive for real-time metrics:
2
With the heightened visibility and data transparency
digital TQM software provides, pharma
manufacturers can clearly visualize and explain what
is happening, when it is happening, and what the
responses have been (or should have been). Make it
a priority to employ modern TQM data management
tools that can empower your personnel to analyze
and act on complex data sets far faster than they can
manually.
3 Fuel continuous improvement by
augmenting audits:
A pharma manufacturer’s audits — for both
performance and compliance — are critical for
producing high-quality products and making
continuous improvement a priority. TQM software
that integrates audit data and processes with quality
and production optimizes your ability to collect,
connect, and share audit-relevant information across
the product life cycle.
reduction in total
manufacturing deviations.
7
3
Trend Brief

Modernizing Batch Records

to Streamline Performance
Highly regulated activities like
pharma manufacturing are practically
synonymous with mountains of
paperwork and labor-intensive
documentation.
It’s not just a common perception — McKinsey researchers
estimate that nearly one-third of a pharma manufacturer’s
staff time is spent on documentation-related activities.15
And it’s no wonder the traditional approach to managing
production records and other essential documentation is so
time-consuming and prone to errors — a typical biotech’s
batch record can contain up to 45,000 manual entries!
In most manufacturing ecosystems, there have historically
been “islands of automation” — applications such as
enterprise resource planning (ERP) systems, learning
management systems (LMS), material resource planning
(MRP) systems, quality management systems (QMS), and
supervisory control and data acquisition (SCADA) systems
— that are all critical, yet disconnected from each other.
With a proven, fully digital production record solution, these
core information system islands become unified and batch
data stays connected between them. The digital integration
between systems provides a more comprehensive view
of business data and makes it possible to act faster on
meaningful performance insights.

Thanks to innovative cloud-based tools, those inefficiencies

can be a thing of the past. The digitization of batch data 1. ERP/MRP
management processes and modern cloud-based batch
record systems are transforming the pharma landscape
and offering pharma manufacturers new opportunities
to dramatically streamline operations. Yet, despite
the availability of efficiency-boosting pharma batch 4. LIMS MES/EBR 2. QMS
record software, 79% of recently polled professionals
in pharmaceutical manufacturing reported that their
organizations are still using paper production records.16 If
you’re in the same boat, it’s time to ask yourself, “Have my
competitors already digitized their batch records?” 3. CRM

Digitized production records are pivotal to closing the gaps
that too frequently exist between a pharma manufacturer’s
information systems and the production floor. With an
electronic batch record system extending digitization beyond
their core systems, manufacturers are empowered to:
• Achieve faster time to market by improving
collaboration, streamlining quality reviews, and
accelerating product release.
• Ensure end-to-end traceability throughout production
and beyond.
• Identify nonconformances sooner.
• Preserve and even enhance data integrity as information is
pushed and pulled between systems.
• Reduce delays and downtime and enforce quality controls
without slowing production.
• Reduce the overall number of deviations and quality
events and manage those that do occur more efficiently.
• Seamlessly capture and share real-time production data
across departments and systems.
Digital and analytics tools
and automation will be the
engines that accelerate agility and
transparency.”17
– McKinsey
Trend Brief
Theoretical to practical:
Connectivity is the key to
production efficiency
1 Digitize your batch records:
When batch records are fully digitized, data stays
connected from beginning to end and there’s no more
need to manually reconcile paper forms and offline
processes. Every event, measurement, and process is
digitally captured and easy to access and act upon.
2 Integrate core systems:
When data is spread across disconnected systems,
it’s impossible to analyze and operationalize it in
context with other cross-functional data. Integrations
between a modern pharma manufacturing execution
system (MES) and ERP, MRP, LIMS, labeling, and
other essential systems streamlines production by
automating information exchange without sacrificing
data integrity.
3 Leverage advanced analytics:
Game-changing analytics tools are enabling
manufacturers to process unprecedented amounts of
data for better and faster decision-making. As these
tools increasingly incorporate artificial intelligence
(AI) and other advanced technologies, they are
enabling manufacturers to start developing predictive
capabilities and mitigate risk more effectively.
9
 Trend Brief

Conclusion
The fiercely competitive pharmaceutical industry is moving
faster than ever. Products and processes are evolving MasterControl Quality Excellence:
with greater velocity and the interest and investment in Smart, dynamic enterprise, plant and
highly specialized therapies is skyrocketing. As flexibility supplier quality management that allows
increasingly differentiates those who can compete from organizations to manage product quality,
those who can’t, it’s become painfully clear that pharma compliance and risk intelligently.
manufacturers must adapt or die.
MasterControl software solutions are designed to make
MasterControl Manufacturing
pharma manufacturers more flexible, more efficient, more
Excellence
compliant, and more competitive. Our pharma manufacturing
Fast, flexible production management and
software solutions keep data connected, eliminate inefficient
execution for process and discrete
paper-based activities, and integrate and automate
manufacturing that connects your shop
production and quality processes. With the operational
floor workers and delivers right-first-time
agility, increased visibility, and improved decision-making
results without the cost and complexity of
provided by the MasterControl Manufacturing Excellence and
a traditional manufacturing execution
MasterControl Quality Excellence solutions, manufacturers
system (MES).
in a continually evolving industry have the modern tools they
need to keep pace with pharma manufacturing trends and
stay ahead of competitors.
MasterControl Insights:
A modern data architecture with advanced
analytics capabilities allows your company
to turn product quality and operational
data into a competitive advantage.

10

References
1. “Pharma operations: The path to recovery and the next
normal,” Katie Kelleher, Ketan Kumar, et al, McKinsey &
Company Life Sciences Insights, May 12, 2020.
2. “2022 Global Life Sciences Outlook: Digitalization at
scale: Delivering on the promise of science,” Deloitte
Global Life Sciences, 2022.
3. “The Needle is Moving: Digital Transformation in
Life-Sciences Manufacturing,” Axendia and Aspentech
research study, 2022.
4. “Pharma & Biopharma Trends CDMOs Face in
2022 and Beyond,” Tim Wright, Contract Pharma,
April 4, 2022.
5. “Innovation Insight: Supply Chain Command Centers,”
Christian Titze and Alexander Hoeppe, Gartner,
June 3, 2022.
6. Supra note 5.
7. Supra note 2.
8. Supra note 3.
9. “Closing the supply chain visibility gap,” Fabrizio
Brasca, Pharma Manufacturing, March 23, 2022.
10. “Life Sciences Industry Experts Weigh In on
Challenges Facing CMOs,” Dave Jensen, GxP Lifeline,
July 14, 2022.
© 2022 MasterControl Inc. All rights reserved. TBXXUSENLT–11/22
Trend Brief
11. “Be responsible and effective: Strike a balance,”
Deloitte EERM/TPRM global survey report, 2020.
12. “Semiconductor chip shortage hits medtech:
Strategies to build resilient supply chains,” Bill Murray
and Stephen Bradley, Deloitte Health Forward blog, Oct.
7, 2021.
13. “Total Quality Management - Meaning and Important
Concepts,” MSG Management Study Guide, accessed
Oct. 21, 2022.
14. “Quality Management Maturity: Essential for Stable
U.S. Supply Chains of Quality Pharmaceuticals,” FDA
Office of Pharmaceutical Quality white paper, July 28,
2022.
15. “Operations can launch the next blockbuster
in pharma,” Ulf Schrader, McKinsey & Company
Operations Insights, Feb. 16, 2021.
16. “How Electronic Batch Records and Device History
Records Close the Digital Manufacturing Gap,” Brian
Curran, GxP Lifeline, Nov. 18, 2021.
17. Supra note 1.
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