Embedding Time-Critical Scheduling in Drug Production

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Pharma intelligence |
Embedding Time-Critical
Scheduling In Drug Production
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2 March 2019 © Informa UK Ltd 2019 (Unauthorized photocopying prohibited.)
Manufacturing is the engine room of the pharmaceutical industry. Ultimately, a
medicine has little value if it does not reach patients on schedule, in the required
quantity and at the expected quality.
Just getting a drug to market is enormously complex and costly. According to the
Tufts Center for the Study of Drug Development, only 12% of medicines enter-
ing development make it through to approval, and at an average outlay (includ-
ing opportunity costs) of $2.558 billion.1
So when a new product does cross that
final hurdle, manufacturers will want to ensure
the whole supply chain runs as efficiently as pos-
sible, for the benefit of their business and cus-
tomers, including patients in need.
It starts with manufacturing, where timing is
critical and the potential for disruption constant.
That is particularly the case when production is
distributed over multiple sites in different coun-
tries, and in more complex facilities for the fast-
expanding range of biological medicines and
other advanced products that now dominate the
pharmaceutical market.
When medicines do not leave the production
line when they are supposed to, and in the right
shape and volume, they are a waste of the man-
ufacturer’s time, resources and money. On-time-in-full (OTIF) delivery is crucial
in an industry where the late arrival of perishable and/or storage-sensitive medi-
cines can render them ineffective. It may also put health at risk and color every-
thing that happens down the line in the product’s journey to patients.
If a batch is rejected for being behind schedule, the manufacturer will have to ab-
sorb the associated costs, along with what could be long-term reputational dam-
age. That is to say nothing of time wasted, and immediate costs incurred, if poor
planning and scheduling result in production batches being held over in compli-
ance with good manufacturing practice (GMP) standards, to the point where they
expire and have to be discarded.
Multifaceted Undertaking
Drug manufacturing is a multifaceted undertaking in which numerous parallel
processes, activities and resources have to be marshaled and reconciled within a
high-pressure environment where human errors inevitably occur. These activities
might incude, to cite just a few examples, interlinked or overlapping production
chains, equipment sharing, sterilization and cleaning procedures, cell growth for
biologics (with its inherent variability), maintaining appropriate staff levels, ensur-
ing GMP adherence and constant documentation/data generation.
Embedding Time-Critical Scheduling
In Drug Production
Drug manufacturing
is a multifaceted
undertaking in which
numerous parallel
processes, activities
and resources have
to be marshaled and
reconciled within
a high-pressure
environment where
human errors
inevitably occur.

The rapid spread of digital technology, which has informed, streamlined and re-
fined many aspects of drug production, in itself presents new challenges, such as
anticipating and managing data breaches, cyber attacks or server failure. Time-
critical day-to-day scheduling, precise but agile finite capacity planning and pro-
active what-if analyses are imperative if pharmaceutical production flows are to
meet the needs of a highly diversified and unpredictable marketplace, as well as
the tough demands of GMP.
The recent US government shutdown, which had a significant impact on routine
operations at the Food and Drug Administration, is one example of how factors
beyond the control of industry can undermine regulatory oversight and, by exten-
sion, market planning. Similarly, the UK’s “Brexit” withdrawal from the European
Union does not bode well for the stability of the European supply chain, nor for
medicines provision to the UK’s National Health Service.
Manufacturing Complexity
The need to manage production activities more closely and efficiently will only
increase as biological and other advanced medicines raise the complexity of man-
ufacturing processes, and as the pharmaceutical market shifts from traditional
batch processing, with its built-in flexibility, toward more seamless continuous
manufacturing. Short-term planning, manual data entry and other traditional
scheduling procedures are no longer fit for purpose in this evolving environment.
The days of the “morning production meeting,” with its Excel spreadsheets, pock-
ets of expertise and uncertain outcomes are long over.
Moreover, the information technology (IT) infrastructure needed to support more
complex manufacturing operations must be fit for purpose, offering best-in-class
technology that delivers not only performance advantages but also the reliability,
consistency and enhanced security to guard against unplanned interruptions to
production flow. In this always demanding environment, pharmaceutical manu-
facturers need to ask themselves some key questions:
•• Do they have business-continuity plans in place to cope with worst-case
scenarios in the event of manufacturing disruption?
•• Do their IT-security provisions meet the exacting standards and accredi-
tations needed to ensure systems are protected from all and any threats?
•• Are these provisions evolving in response to changes in the nature of se-
curity risks?
•• Do their planning and scheduling systems enable collaboration and trans-
parency at all times across multiple teams and sites?
•• Does their in-house resource or IT supplier have the expertise and experi-
ence to deal with increasingly complex set-ups in production planning
and scheduling, such as multiple systems and hybrid cloud environments?
•• Does their business have access to best-in-breed technology, or is it strug-
gling with legacy hardware, software and servers?
•• Are the costs of production planning and scheduling systems transparent
and predictable?
Short-term planning,
manual data entry
and other traditional
scheduling procedures
are no longer fit
for purpose in this
evolving environment.

Software And Infrastructure
Digital technology and real-time data now permeate every aspect of the sup-
ply chain, opening up opportunities to align production tasks while addressing
new regulatory requirements such as digital audit trails to deter counterfeiting.
On their own, though, the massive volumes of data generated by modern manu-
facturing systems are little more than white noise. Raw data need to be filtered,
analyzed and interpreted so they can be translated into meaningful insights and
action that transform business strategy and operations.
With the right Finite Capacity Planning software and IT infrastructure, pharmaceuti-
cal manufacturers can radically improve scheduling, operational efficiency, capac-
ity utilization, productivity and profit margins by centralizing data capture, storage
and management within a secure, high-performance infrastructure to take real-
time control of production planning, input and output. Among other benefits, this
will help companies to:
•• Plan ahead for maintenance work on manufacturing systems.
•• Design what-if scenarios to plan for, and respond promptly to, disruption,
whether it comes from regulatory demands, shifts in the operating envi-
ronment, human fallibility or new external threats such as cyber attacks.
•• Eliminate reliance on daily spreadsheets and siloed expertise in discrete
aspects of production.
•• Virtually model scenarios for capacity demand or crisis management.
•• Identify and eliminate production bottlenecks (e.g., Clean and Sterile hold
times).
•• Improve OTIF delivery rates for finished pharmaceutical products or in-
termediates.
•• Make real-time scheduling updates and communicate them immediately
to production managers and staff.
•• Reduce levels of work in progress.
•• Order manufacturing materials with “just in time” efficiency.
•• Accurately forecast daily labor requirements and save on temporary staff
costs.
•• Shorten lead times by synchronizing processes and controlling workloads
and resource allocation.
•• Integrate related organizational functions such as management, sales,
procurement or customer services.
•• Review actual against planned manufacturing performance at multiple
levels.
Raw data need to be
filtered, analyzed
and interpreted so
they can be translated
into meaningful
insights and action
that transform
business strategy and
operations.

At the same time, by maximizing their IT infrastructure and tapping into cloud
hosting capabilities for automated production planning and scheduling systems,
companies will have the technical support necessary to manage complex manu-
facturing operations while boosting efficiency, consistency, reliability and cost-
efficiency. For example, they can improve the performance of Access Orchestrate,
The Access Group’s advanced planning and scheduling software, by up to 30% by
hosting it on the Access Alto cloud platform, as opposed to using a third-party
environment. This means better responsiveness, so the system will react more
promptly to requests; and reduced processing time, so Orchestrate will execute
requests more quickly and efficiently.
In particular, multiple sites in different locations or countries can plug into a sin-
gle, cloud-based source of real-time information on manufacturing activities and
planning. That way, everyone involved in pharmaceutical production, at whatever
level of the business, will be on the same page about strategic and operational
priorities on a day-to-day and hour-to-hour basis.
A superior IT infrastructure will also provide tighter security against data breach-
es, cyber attacks, ransomware and the whole range of potential incursions that
come with digitalization. These can wreak significant financial and reputational
damage if production is halted and the supply chain disrupted.
Access Orchestrate
production planning and
scheduling software, replaces
time consuming and error
prone spreadsheets with a
visual, real-time production
plan. It helps to increase
manufacturing efficiency
by providing visibility of
the end-to-end production
process, improving
communication between
departments and giving
better utilization of resources
including manpower, stock
and machinery.

With modern automated software giving real-time, 360-degree visibility to manu-
facturing processes, companies can leave behind laborious morning production
meetings, short-term planning, knowledge silos, poor communications and unex-
pected schedule changes. Instead, they can embed time-critical scheduling and
dynamic planning as core strategies that optimize manufacturing capability, cut
waste and get vital medicines to patients more quickly, reliably and efficiently.
STREAMLINED MANUFACTURING PLANNING
A global pharmaceutical-manufacturing client sought to streamline its production planning by investing
in Access Orchestrate. The client’s manufacturing processes were a complex mix of intermediate solutions
involving multiple stages, whereby products were vying for space and resources within the production plant.
Hundreds of discrete activities and processes had to be managed and implemented around the clock.
Previously, these challenges were addressed by a team
of seven full-time planners, each with a detailed knowl-
edge of specific aspects of the production process.
Armed with Excel spreadsheets, these planners would
meet daily and spend a whole morning updating a
combined production plan to take account of any un-
foreseen events during the last 24 hours.
These combined plans had a rolling horizon of just one
week ahead. Moreover, the resulting plans lacked any
coordinated visibility at plant- or individual-resource
level. It was not unusual for engineers to turn up ex-
pecting to conduct planned maintenance, only to learn
that the production schedule had changed.
With Access Orchestrate, the production-planning horizon is now four weeks ahead and the planning process
takes only one hour a day to complete, instead of a whole morning. With giant touch-screen smart boards
at floor level and user screens providing visibility around the plant, everyone in the facility – from shift man-
agers and supervisors to shift engineers and engineering planners – has real-time access to the production
plan. Among other benefits, this makes for smoother shift changeovers and full integration of maintenance
activities at the plant.
CASE STUDY 1

PLANNING FOR A PANDEMIC
Baseline Controls, a planning and engineering consultancy based in North Carolina, was commissioned by
the US government and a leading pharmaceutical company to carry out a design-capacity study for a facility
that could produce enough vaccines (150 million doses) for half the US population in the case of an influenza
pandemic. The required maximum delivery time was six months.
Equipped with data from a limited number of initial batch runs, including
product cycle times, Baseline Controls looked for a planning and scheduling
solution that would provide proof-of-concept for its stakeholders. The com-
pany opted for Access Orchestrate, based on its ability to carry out “what-if?”
analyses and to optimize available resources, saving time, cutting wastage
and improving operational efficiency.
Using Access Orchestrate, Baseline Controls’ consultants conducted a de-
tailed analysis of capacity long before full production of the vaccines began.
Once the forecasting model was built and the level of demand identified, the
consultants could show how long each batch run would take, and highlight
any areas where equipment was being over- or under-utilized.
These analyses demonstrated how the manufacturing site could ultimately speed up demand delivery by
three weeks. Moreover, they reassured the client that, with some strategic process improvements, the facility
could produce sufficient quantities of vaccines to be “pandemic-ready.”
“The speed at which Baseline Controls developed a proof-of-concept, based on Access Orchestrate, was
tremendous,” comments Rod Schregardus, operations director at Access Group. “They built the model in
just under two weeks and provided the kind of detailed what-if analysis crucial for a project of this scale and
nature.”
Phase 2 of the project involved the pharmaceutical client scaling up use of Access Orchestrate across its
manufacturing facility for day-to-day production scheduling. Before rolling out the platform, the facility
struggled to meet its projected batch run of six per week. Using Access Orchestrate, the company was able
to identify equipment and labor bottlenecks, act on them, and meet its target.
Access Orchestrate has also brought a number of time-saving benefits. It enables production teams at the
facility to transition from a manual, potentially inaccurate, system of spreadsheets to full production visibil-
ity. That means busy professionals have more time to analyze data, schedule equipment maintenance and
ensure that all resources are used optimally.
In addition, the software has made data-sharing much leaner, so that each tier in the company structure can
view and act on information relevant to them. At ground level, teams rely on hour-by-hour shop-floor data
capture to ensure that production is running to plan. Key findings are then communicated to senior manag-
ers, who can use the data to improve overall operational efficiency and develop longer-term strategies.
CASE STUDY 2

MAXIMIZING PRODUCTION EFFICIENCY
Nolato Jaycare is a global specialist in the design and manufacture of rigid plastic packaging, with a market-
leading presence in the pharmaceutical and health care sectors. It employs complex manufacturing se-
quences for a wide range of products with very different characteristics, configurations and color options.
Many of these products must also conform to strict regulatory requirements. The company adopted Access
Orchestrate to automate and enhance its production scheduling while driving down manufacturing costs.
Nolato Jaycare already used an enterprise resource planning (ERP) system at its manufacturing facilities, but
this lacked the capacity to manage highly detailed scheduling requirements. Before adopting Access Orches-
trate, for example, the company’s planners relied on spreadsheets to balance constraints when combining
resources such as molding tools, technical support for tool changes and ancillary equipment (e.g., heaters).
One reason Nolato Jaycare chose Access Orchestrate was because it was the only solution that could support
multiple planners in multiple locations. “We have factories and planners in both Newcastle and Portsmouth
and we wanted our planners, each looking after their own set of machines, to be able to use the system at
the same time,” notes the company’s IT director, Peter Teague.
With the new setup, master data, such as product information, bill of materials, production routes and stock,
are all maintained within Nolato Jaycare’s ERP system. Access Orchestrate manages the more detailed infor-
mation needed for scheduling, such as optimal color sequencing.
Customer orders are logged into the ERP, then transferred automatically into Orchestrate for more complex
planning processes, with work orders feeding back into the ERP. Both systems work seamlessly together to
eliminate unnecessary data entry and associated transcription errors.
Among Nolato Jaycare’s key performance objectives
were reducing work in progress (WIP), cutting lead
times and limiting wastage. “Because we have so
much more confidence in our scheduling, we don’t
have to run so far ahead with production, which has
resulted in a 25% reduction in WIP,” Teague com-
ments. “Customers are delighted because lead times
have now been cut from 6–8 weeks down to 4–6 weeks
… Wastage has been cut significantly, simply because
we have fewer tool changes.”
Among other benefits is an increase of around 5% in productivity from the company’s packers, while Nolato
Jaycare’s OTIF delivery rates have gone up from 92% to 97%. Less quantifiable improvements include re-
duced planning headcount and more time to take on extra responsibilities, such as procurement planning.
Communications have improved both internally and externally, while the capacity to make changes directly
into Orchestrate has enabled Nolato Jaycare to move more suppliers to a Kanban system for lean and just-
in-time manufacturing.
CASE STUDY 3

Hosted Solutions
Access Orchestrate can address all of these challenges while integrating with ex-
isting enterprise resource-planning and manufacturing-execution systems or in-
terfacing with applications such as Microsoft Access, Excel and other stand-alone
databases. Hosting Orchestrate on the Access Alto cloud platform provides ad-
ditional benefits without significant capital investment, such as access to a single
source of real-time information from multiple manufacturing sites, and a highly
secure, proven and resilient hosting platform. In the event of disruption, business-
continuity plans come as part of the package, whereas on-premise systems may
not provide sufficiently robust backup.
As the software IPR owner, Access knows exactly how Orchestrate works and
what it can do. The hosted environment is optimized to ensure the best possible
performance of the software. As in other manufacturing sectors, pharmaceutical
companies are looking for continuous improvement, so any gains in performance
and efficiency are highly valued.
In powering the hosting infrastructure for Access Alto and Orchestrate, VMware
leverages best-in-class technology to deliver high standards of performance, se-
curity and reliability. Encryption at rest, software defined networking (SDN), dis-
tributed firewall technology via VMware NSX, and automated detection and re-
sponse to events are at the core of the VMware architecture. Security is built into
the cloud-platform design from the ground up.
Ever-Present Threat
Drug manufacturing is in no way immune from the ever-present threat of cyber
attacks, data breaches and ransomware that can bring key processes to a halt at
substantial cost to productivity, customer relations, patient health and the bottom
line. Pharmaceutical companies need to be sure they have cutting-edge solutions in
place that will not only optimize protection against a shifting landscape of risk, vul-
nerability and potential incursion, but will also provide swift and effective disaster
recovery in situations where manufacturing disruption cannot be avoided.
At the same time, these companies should as a matter of urgency be migrating
to a single, dynamic manufacturing schedule, visible at all times and at all levels
of their organization. In that way they can clarify priorities, eliminate overlaps,
make the best use of available resources, and boost efficiency and throughput
to the benefit of margins, customer relations, health systems and patients. By
combining an advanced planning and scheduling solution such as Access Orches-
trate with the very latest in-cloud technology, and the performance and security
advantages of the VMware-powered Access Alto IT architecture, companies can
stay competitive by streamlining and optimizing their manufacturing for today’s
fast-moving and increasingly challenging pharmaceutical market.
Pharmaceutical
companies need to
be sure they have
cutting-edge solutions
in place that will
optimize protection
against a shifting
landscape of risk…
REFERENCE
1. A Tough Road: Cost to Develop One
New Drug Is $2.6 Billion; Approval
Rate for Drugs Entering Clinical
Development Is Less Than 12%.
Thomas Sullivan. Policy & Medicine.
May 6, 2018. Retrieved from https://
www.policymed.com/2014/12/a-
tough-road-cost-to-develop-one-
new-drug-is-26-billion-approval-rate-
for-drugs-entering-clinical-de.html

Why go hosted
Deliver your Orchestrate software in the most reliable,
resilient and cost efficient environment.
With rapid changes in the business landscape shaking
up the market, it is becoming increasingly important
to ensure that your business has the appropriate
IT infrastructure in place to remain efficient and
competitive whilst delivering the high levels of service
that many clients and staff now expect.
However, the resources to do this can be expensive in
terms of time, cost and resources.
Our managed application hosting solution provides
all the benefits of the latest technology without the
significant capital investment.
Hosting Orchestrate on the Access Alto cloud platform
delivers the following benefits:
Highly secure and reliable – Our hosted platform
is ‘Enterprise Grade’, split across two of the UK’s
premium data centres, and all covered by ISO27001,
helping you to increase cyber security and reduce
GDPR risk.
Improved cost efficiency and predictability – We offer
a highly available solution with predictable annual
fees in ‘the cloud’, eliminating often unmanageable
and unforeseen Microsoft SQL licencing costs and
server upgrades.
Anywhere, anytime access – Easily connect to your
system from anywhere on any device* as long as you
have an internet connection, supporting a diverse and
increasingly mobile workforce.
One supplier with software expertise – Manage one bill
for your software and IT requirements, one contract and
one set of SLAs.
Increased support, performance and maintenance -
Access are the experts in building, maintaining and
hosting Access software applications.
Below are some of the things that are included within
the service as standard
• Microsoft Licencing Costs
• Fixes, patches and updates
• Data Backup and Disaster Recovery (ensuring a robust
Business Continuity Plan for a business critical system)
Database management – All Microsoft SQL database
administration is included and carried out by dedicated
MS SQL Administrators, ensuring that your database is
monitored, protected, optimised and backed up.
Why choose Access Alto
We offer a powerful and cost effective solution for
businesses that need the very best technology to
support their software and wider business applications.
We’re technologists at heart – at our core we are
engineers with a passion to find innovative solutions to
deliver business outcomes.
Expert help when you need it
Talk to a real person 24/7 at no extra cost – our
exceptional support team is made up of third line, highly
skilled technical engineers only.
Highly competitive pricing
Enjoy all the benefits of an enterprise class
infrastructure for a fraction of the cost, with a fixed price
per user.
World-class IT infrastructure
Take the legwork out of building IT - tap into our world-
class architecture in two of the UK’s premium data
centres, anchored by the latest cutting edge technology.
Peace of mind
Our platform is built with security in mind, helping
you manage, secure and protect sensitive data to the
highest standards on a daily basis (SSAE16 SOC2, HIPAA,
ISO27001, Privacy Shield).
Only the best technology
We partner with the some of the best providers
including VMware, NetApp, Veeam, Zerto and Cisco,
which offers a rock-solid foundation for your business.
About VMware
VMware powers Access Alto’s hosting solution. They’re
the industry leading virtualisation solution, offering best
in breed technology which delivers high performance,
reliability and enhanced security.
For more information, go to:
https://www.theaccessgroup.com/hosting/
https://www.theaccessgroup.com/production-planning/

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Embedding Time-Critical Scheduling in Drug Production

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