The pharmaceutical supply chain is long and complex. There are many challenging requirements placed on pharmaceutical organisations in terms of demand management, supply chain planning, process-based manufacturing, discrete manufacturing, product traceability and quality management. These requirements, together with the need for regulatory compliance place huge demands on the computer systems which support pharmaceutical organisations. This report looks at ERP in the Pharmaceutical Industry and the many challenges involved. View an extract of the report and download the full report for free at: http://www.lumeniaconsulting.com/resources/reports-white-papers/erp-pharmaceutical-industry

1. ERP in the Pharmaceutical Industry
- Complex functional requirements create significant challenges for ERP systems
September 2013

2. ERP in the Pharmaceutical Industry
Page 2 of 3
Introduction
The pharmaceutical supply chain is long and complex. There are many challenging
requirements placed on pharmaceutical organisations in terms of demand
management, supply chain planning, process-based manufacturing, discrete
manufacturing, product traceability and quality management. These requirements,
together with the need for regulatory compliance place huge demands on the
computer systems which support pharmaceutical organisations.
ERP in the Pharma Industry
The pharmaceutical supply chain can be illustrated as follows:
This article focuses on the upstream manufacturing activities.
One of the most fundamental things to consider when looking at ERP in
pharmaceutical manufacturing is the overall systems landscape into which the ERP
system is being placed. All API and formulation plants and most packaging plants will
have a number of other systems in place besides the ERP system. These include
manufacturing execution systems (MES), supervisory control and data acquisition
systems (SCADA) and distributed control system (DCS). In addition, many will also
have separate laboratory information management systems (LIMS), dispensary
systems, quality management and document management solutions. The challenges
for ERP in this type of environment depend very much on this landscape and how
one intends to use the ERP system.
At one end of the spectrum, things may be very simple. The ERP may just be used for
planning materials and production and controlling costs, but all of the detailed
inventory management of API and other ingredients is managed by the dispensary
system and/or the various MES/control systems. At the other end of the spectrum,
the ERP system may actually be doing many of the functions which are normally
done in other point solutions within the overall systems landscape.
The pharmaceutical manufacturing process itself has a number of key stages. The
stages in relation to the production of the API are typically process-based. This
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3. ERP in the Pharmaceutical Industry
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requires functionality to support inverted bills of material, by-products, co-products,
management of sub-lots, lot grading, etc. However the stages in relation to the
formulation and packaging of the product are typically discrete. Any ERP system
operating across all production stages will need to be capable of handling both
process-based and discrete manufacturing. Other challenging requirements include:

Batch processing. Pharmaceutical products are produced in specific batch
sizes. These batch sizes are registered with the Regulators and it is not easy
for companies to deviate from them. As with any batch process, individual
production batches will vary in terms of yield and strength (potency). This
creates the need for functionality within the ERP system to control batches
of the same active ingredient with different yields and potency.
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About Lumenia
Lumenia is a leading independent ERP consulting organisation and is not aligned with any
ERP or other vendor of business software.
We provide objective advice and experienced project resources to organisations that are
planning to upgrade or change their ERP systems. Specifically, we provide services in the
following areas:
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ERP
ERP
ERP
ERP
ERP
ERP
strategy development
product and vendor selection
project management
change management
data migration management
systems validation.
We have offices in Ireland and the UK and work globally with many of the world’s leading
companies.
For more information, please contact Lumenia at:
Ireland
Parkmore Business Park West, Galway T: + 353 (0) 91 746940
UK
71-75 Shelton Street, Covent Garden, London, WC2H 9BP T: + 44 (0) 207 4708766
W: www.lumeniaconsulting.com E: info@lumeniaconsulting.com
Copyright BSM Ireland 2013. Lumenia Consulting is a registered Business Name of BSM Ireland Ltd.
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