Effectively managing a sample-distribution program requires, at minimum, two things: meeting the regulatory requirements of the Pharmaceutical Distribution and Marketing Act (PDMA), and satisfying the manufacturer’s needs for shipping sample cases to a multiplicity of locations under dynamic, swiftly changing market conditions. Being able to append a compliant returns-processing function (to retrieve recalled or expired samples) onto this only adds to the complexity.

Those are the service offerings of Priority Solutions International (Traverse City, MI), a third-party logistics (3PL) provider that specializes in pharmaceutical distribution. Meanwhile, the company itself has undergone rapid evolution. The company itself was formed in 2005 by the merger of Priority Air Express (Swedesboro, NJ) and Distribution Services International. Distribution Services had been offering pharmaceutical services since 1993. In 2003, it significantly expanded its warehousing capacity with a 125,000-sq.-ft. facility in Memphis, TN. This year, it is expanding its capabilities for handling controlled-substances distribution with obtaining a DEA license, and added capital investment.

Now, the company says that it is shipping 35,000 cases per week from the facility, and confirming delivery with clients most often within 48 hours of shipping. The company has relationships with over 30 carriers (including international shipping) offering road, air and ocean freight services, which in turn are supported by over 400 local delivery vendors for “last mile” service. “The most important aspect of this operation is maintaining a chain of custody from the manufacturer, through out internal processes, over to our carriers, and out to the physicians’ offices or other destinations that the samples are reaching,” says Veronica Moyer, VP, business development.

“When we were specifying the IT system that supports the warehouse operations, we knew that first and foremost we needed a system that wouldn’t hold us back,” says Dan Randall, GM. The company selected Integrated Warehousing Solutions (Downers Grove, IL), and its IRMS warehouse management solution (WMS).

Barcode Scans

Moyer and Randall say that the Memphis operations begin with receiving inventory, which is immediately scanned, cross-checked against Advanced Shipping Notices (ASNs), and then labeled. The label is electronically assigned to a pallet ID (which also provides a location identification). Customer orders come in daily, weekly and monthly, via electronic orders, e-mails, phone and fax.

With orders in place, the warehouse staff moves to a line-haul fulfillment process, picking and placing, with a goal of ensuring that only full shipments go out. Order fulfillment can involve extensive kitting operations to complete a complex order. Unlike routine retail shipments, Priority Solutions is delivering samples and multiple locations tracking pharmaceutical sales reps, who need to have appointments scheduled for residential delivery (both for security purposes and to maximize time on the road). Priority Solutions offers a two-hour window for delivery, and says that 75% of the time, products are delivered within the first hour.

The IRMS WMS supports these functions with a system that is said to be 100% compliant with FDA’s GAMP4 (Good Automated Manufacturing Process) standards. According to Carl Brewer, president of Integrated Warehousing Solutions, IRMS is designed with extensive decision-support functions that are designed to automate much of the order-fulfillment details, for example, geographic constraints, product release dates, or special packaging. As the WMS matches order specifications with the fulfillment process, warehouse employees are freed from repeatedly checking paper documents or other information sources while completing the order.

The other key function, says Brewer, is to both accept and generate reports, in order to meet customer requirements for verification, and to provide an audit trail for regulatory compliance. Priority Solutions takes advantage of these capabilities by providing a Web-based Client Central application that gives clients visibility of where an order is in the warehouse, or in the supply chain.

Reverse Logistics Capabilities

Priority Solutions also touts its ability to manage returns or recalls; last year, it was called on to retrieve samples from over 3,500 representative locations, for which it engaged 120 local delivery agents. The process was completed in less than a month, with full documentation, and with on-line visibility throughout the process for the client. The company can also manage a “gate-keeping” function, determining which shipments are eligible for re-direction versus return, thus optimizing product availability.

“We already have track-and-trace capabilities in our internal operations,” concludes Priority Solutions’ Moyer, “and we’re getting ready for the industry-wide requirements that pedigree rules will bring. Meeting our customer requirements in product integrity and chain of custody will be very important going forward.”

Links external to the company will open in a new window.