Putting Together the Pieces - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Putting Together the Pieces
Several strategies and software applications help pharmaceutical companies integrate their manufacturing execution systems and enterprise resource planning systems


Pharmaceutical Technology
Volume 32, Issue 10, pp. 40-46


Illustration by M.McEvoy. Images: James Hardy, AtomicSupersonic, Photodisc (Getty Images)
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.

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 processes.

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?

MES. 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. 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 raw materials.

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: Pharmaceutical Technology,
Click here