Pharma braces for new regulations that test ERP's quality, manufacturing tools

In November 2013, legislators initially introduced the Drug Quality and Security Act (DQSA) - a proposed law that would include the Compounding Quality Act and the Drug Supply Chain Security Act. The first sets up a voluntary compliance arrangement for pharmaceutical firms and the other requires the FDA to develop a national track-and-trace system that manufacturers must use when introducing products into the supply chain. 

The bill was signed into law in 2013, but manufacturers had until January 2015 to implement portions of the required labeling, tracking, and paperwork. A company's ability to meet those standards will depend in large part on the capabilities of their existing ERP system.

"One problem," states Gene Hammons in New Gov't Regs? The Empire Strikes Back!, "FDA regulatory guidance - the actual rules everyone is supposed to follow have been....wait for it....you know it's coming....delayed."

Increased Oversight

As practice director for Vaco Resources, Hammons is in charge of the firm's ERP evaluation and implementation practice. He's been involved with FDA-regulated industries since the 1980s - pharma, biopharm, nutraceuticals, etc. - and has spent the last few years helping food manufacturers prep for the Food Safety and Modernization Act (FSMA).

One particularly onerous part of the new pharma-related regulations involves serialization - a requirement stemming from the DQSA. Of particular interest is a section of that law called the Drug Supply Chain Security Act (DSCSA). According to Hammons, in an effort to crack down on counterfeit medications, drug manufacturers will start putting serial numbers on actual shipments, along with tracking paperwork, and a history of which distributors, shipping companies, and pharmacies have stocked or handled a particular shipment of ...