The pharmaceutical industry is a fairly old industry, and as such, the modern manufacturing facility really reflects an evolution—the
aggregate of incremental changes. For example, the plant today is far more automated than its antecedents. It can be managed
in part through software that didn't even exist when the industry was young.
Illustration by M.McEvoy. Images: James Hardy, AtomicSupersonic, Photodisc (Getty Images)
The software packages that have evolved include manufacturing execution systems (MES) and enterprise resource planning (ERP)
systems. MES helps pharmaceutical companies monitor and control the plant floor. ERP systems help manage and monitor business
Integrating these new applications into a cohesive whole can bring a manufacturer great control, speed, and flexibility, but
is a difficult project. Information technology (IT) standards, newly emerged tools, and planning, however, can make it easier
to link the factory floor to the management suite to achieve great benefits.
What are these systems?
The Instrumentation, Systems, and Automation Society (ISA) defines MES in its ISA-95 standard by providing data structures
that represent the information that it manages (e.g., material, equipment, personnel, machine capability, and machine schedule).
The manufacturing benefits of MES are manifold. The system automatically checks whether manufacturing equipment is operating
within the correct parameters. It also verifies that components (e.g., containers) are appropriate for a particular production.
Thus, it can reduce a site's number of material exceptions. Exceptions can be handled immediately, and deviations can be channeled
into a corrective action/preventive action system.
In conjunction with these checks, MES includes a process for electronic signatures and approval for each manufacturing activity.
This function provides additional oversight of the production cycle and facilitates regulatory compliance.
Manufacturing-data management also can be enhanced by MES. The system collects production data and creates electronic batch
records that are available for analysis after production is complete. Electronic batch records enable review by exception,
says Brian Leinbach, MES deployment lead for Wyeth Pharmaceuticals (Madison, NJ). MES's initial equipment and material checks
reduce exceptions and, consequently, batch-record review time—often dramatically. Leinbach reports that MES helped one of
Wyeth's sites reduce its cycle time from 36 h to 4 h, largely because it streamlined the record-review process.
MES identifies processes that could be modified to improve efficiency, so it helps reduce manufacturing-cycle time. The process
optimization that MES enables can yield labor efficiencies, improved compliance, process robustness, and repeatability.
ERP systems are likewise designed to collect, monitor, and store near-real-time data from various sources within a company
and archive them in a single repository. Their goal is to improve business planning by providing easy access to current, detailed
information. Most ERP systems store data for various functions (e.g., purchasing and supply-chain management) in a unified
database. In other cases, a company will create an interface to allow its ERP system to access data in other systems.
ERP systems can help companies streamline business processes and workflows. The systems also enable various departments in
a company to share data easily and help improve project and inventory tracking, demand forecasting, and resource planning.
If an ERP system replaces several smaller systems (e.g., supply-chain management and warehouse management), it reduces a company's
software-maintenance requirements. When the ERP system establishes a single database for several departments, it can provide
detailed reports easily.
How does integration help?
For an ERP system to provide the greatest advantages, a pharmaceutical manufacturer must integrate it with MES. Integrating
the two systems helps companies perform global supply-chain planning by facilitating real-time monitoring of productivity,
quality, and throughput. Integration also allows management to see the current location of inventory, work-in-progress, and
Another benefit for supply-chain planners is the ability to identify ingredient suppliers and contractors that could take
part in a lean manufacturing process, according to Jim Sabogal, vice-president of industry solutions for life sciences at
SAP (Newtown Square, PA).