By nature, pharmaceutical manufacturing operations are complex, inefficient, and consequently costly. Due to the inherent complexities, the cost of poor efficiency and its root causes are often not well understood by many manufacturers.

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TM
Tackling the Challenges
of Pharmaceutical
Manufacturing

2. By nature, pharmaceutical
manufacturing operations
are complex, inefficient, and
consequently costly. Due to
the inherent complexities,
the cost of poor efficiency
and its root causes are often
not well understood by many
manufacturers.

3. Introduction
Contrary to what may be perceived—in
most cases—the cost of manufacturing
operations significantly exceeds that of
research and development. It is imperative to
continuously identify the root causes for poor
efficiency, classify and rank opportunities for
improvement, and to undertake corrective
measures to increase the productivity of
manufacturing operations.

4. Kaizen programs use a blitz
approach to identify and
fix problems quickly. They
tend to focus on equipment-
related issues and as a
result, they are simpler
to undertake with faster,
localized results.

5. Continuous
have a defined strategy, valid
methodology, and the right
process analytical tools. Many
pharmaceutical manufacturers
have adopted methodologies
such as Kaizen, Lean, and
Six Sigma as part of their
continuous improvement
initiatives.
Kaizen programs use a blitz
approach to identify and fix
problems quickly. They tend
to focus on equipment-related
issues and as a result, they
are simpler to undertake with
faster, localized results.
Lean programs tend to focus
on topics such as value stream
mapping, logistics, waste and
cost reduction, inventory
management, and cycle-time
improvement. Lean programs
are typically of medium
complexity and require more
time and broader reach than
the Kaizen approach.
Six Sigma programs use
statistical tools and focus on
reduction of variability. Typical
goals are prevention of defects,
improving predictability, and
achieving process excellence.
These programs are often
complex, require significant
time investment, and have a
broad scope.
Without methodical, continuous,
improvement initiatives in
place, elevating efficiency in a
meaningful fashion is unlikely.
Although many manufacturers
have active continuous
improvement programs in
place, many are not reaping the
expected benefits largely due to:
• Absence of a committed
culture and a defined
strategy.
• Unattainable expectations
and bad assumptions.
• Insufficient training.
• Poor visibility to accurate,
timely and actionable data.
• Focusing on treating the
symptoms of inefficiency.
• Lack of understanding of
the root causes.
• Unavailability of relevant,
real-time, performance
indicators on which to base
decisions.
• Singular focus on
equipment instead of
overall production process.
• Inadequate understanding
of process variability.
Arguably, continuous
improvement is a major goal
of PAT. Successful continuous
improvement programs must

6. Knowledge
Management and
Decision Support
Tools
Once an organization has
determined their strategy and
methodology for continuous
improvement, it is imperative
to select the right knowledge
management and decision
support tools. This is not
necessarily a simple task; quite
often, the existing business
systems and manufacturing
operations infrastructure are
complex and involve incompatible
technologies, legacy systems,
multitude of suppliers, disjointed
connectivity, and insufficient
security.
Ideally, the chosen tools:
• Must work regardless of
methodology selected for
continuous improvement.
Best practices often require a
hybrid approach.
• Won’t require changes to
the existing infrastructure,
and must work with existing
systems and processes
regardless of make, model,
vintage.
• Can be deployed quickly
and economically without
disrupting production and
must be non-intrusive.
• Comply with regulatory
requirements (e.g., 21
CFR Part 11) and remove
regulatory uncertainty.
• Can effectively identify
factors affecting quality and
performance. Scientifically

7. determine and rank the root causes for poor quality and
performance.
• Provide the type of quality and process improvement
recommended by PAT. Making it possible to bring about
innovation while managing risks.
• Won’t add complexity disproportional to benefits: Easy to
use and manage by those it’s intended for.
• Must be scalable, to allow extensibility commensurate with
needs, and localized to the enterprise.
• Must provide the needed intelligence for effective decision
making. Poor decisions based on poor information often
lead to poor performance.

8. Process Analytical
system: quality cannot be
tested into products, it should
be built in or should be by
design.
There are many current and
new tools available that enable
scientific and risk-managed
pharmaceutical development,
manufacturing, and quality
assurance. These tools,
when used within a system,
can provide effective and
efficient means for acquiring
information to facilitate
process understanding,
develop risk-mitigation
strategies, achieve continuous
improvement, and share
information and knowledge.
in the PAT framework, these
tools can be categorized as:
• Data acquisition and
analysis tools.
• Process analyzers
or process analytical
chemistry tools.
• Process monitoring and
control tools.
• Continuous improvement
and knowledge
management tools.
Effective, continuous
improvement programs
must leverage subject matter
experts, involve cross-
discipline teams, use analytical
tools, follow best practices,
and regularly execute
corrective actions.
The US food and drug
administration (FDA) has
defined a framework—
referred to as Process
Analytical Technology (PAT)—
that promotes voluntary
implementation of innovative
pharmaceutical development,
manufacturing, and quality
assurance.
Specifically, PAT is a system
for designing, analyzing, and
controlling manufacturing
through timely measurements
(i.e., during processing)
of critical quality and
performance attributes of raw
and in-process materials and
operations, with the goal of
ensuring final product quality.
According to the FDA, the goal
of PAT is to understand and
control the manufacturing
process, which is consistent
with the current drug quality

9. An appropriate combination of some, or
all, of these tools may be applicable to
a single-unit operation, or to an entire
manufacturing process and its quality
assurance.
TrakSYS™ by Parsec is a leading real-time
decision support solution that is widely
used by pharmaceutical companies to
measurably improve asset utilization and
productivity. TrakSYS™ is a Service-Oriented
Architecture (SOA) application with various
components specifically designed to meet
the varying needs of users and their unique
operational excellence goals.
TrakSYS™ takes the guess work and
reliance on intuition out of the decision-
making process by providing the required
information to the right people—when
they need it—regardless of where they
are located. By analyzing the impact of a
multitude of variables across the value
chain on product quality, yield, schedule
compliance, goal attainment, and cost,
TrakSYS™ empowers the stakeholders to
make fact-based decisions that will often
deliver on the promise of quality by design.
Ensure Product Quality
and Performance with
TrakSYS™

10. Figure 1 - Cost Benefits of a Software Solution

11. of poor quality attributable to
their responsible operations
in a timely manner so that
improvements will be made to
avoid costly losses.
With TrakSYS™ you can expect:
• Innovation that delivers
on its promise without
regulatory risks, no
business or production
disruption, and
infrastructure independent.
• A responsive and proactive
workflow with repeatable
good results (lower
variability).
• Better Decisions, managing
expectation, avoid costly
assumptions, don’t simply
rely on intuition.
• Improved performance
visibility into; internal
resources, assets,
suppliers, procedures, and
materials.
• Increased internal rate of
return (IRR), yielding better
asset utilization.
• Lower total cost of
ownership (TCO) with
reduced IT cost to support
software.
• Decreased cost of finished
goods manufactured
(COFGM). Much better
quality and higher yield.
• Reduced labor, reduced
materials and energy costs,
higher on-time completion
of quality goods, faster
cycle times, lower materials
cost, and smaller carbon
imprint.
• Improved profitability,
create a competitive edge
for better shareholder
value.
TrakSYS™ non-intrusively
gathers the raw data from
various sources in real-time. The
gathered data is then processed
through the configurable and
rules-based analytics and then
the resulting, personalized
intelligence is securely
distributed in real-time to the
authorized users.
TrakSYS™ effectively models and
analyzes the various aspects
of the manufacturing process
and delivers the findings sorted
by rank/impact, discipline, and
criteria selected by individual
users. This targeted delivery
of pertinent information
avoids information overload
and enables the recipients to
focus their decisions to get the
most positive impact relevant
to productivity and quality
enhancement. Ultimately, the
workflow is transformed from
the usual reactionary practice to
a proactive (and preemptive—
if warranted) doctrine that
inherently supports quality by
design. Consider the challenges
associated with sustainable
quality improvement.
What are the root causes for bad
quality? Are they design related?
Could they be because of third-
party supplies (e.g., components,
ingredients, services, etc.)?
How about procedures? Would
equipment play a role in the
quality? What about personnel
training? The bottom line is
that there are many variables
that will absolutely affect
the final quality. In order to
consistently and effectively
manage quality, the adverse
impact of all these variables
must be assessed continually.
Also, the stakeholders must be
kept informed of the root causes

13. TM
About Parsec
Parsec is the developer of TrakSYS™, a proven operations management
software application and solution platform designed to significantly improve
manufacturing processes. Parsec is committed to providing best-in-class products
and solutions to our worldwide community of clients to assist them in optimizing
their manufacturing operations. There are thousands of TrakSYS™ licenses in use
around the globe in a wide variety of Industries.
TrakSYS™ helps manufacturers to maximize asset utilization and efficiency,
increase capacity with no new capital equipment, reduce production costs,
decrease lead time, and improve profitability. For more information about Parsec
and TrakSYS™ please visit the corporate website at www.parsec-corp.com.
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