Materials Tracking: It's All in the Data

By Angelo De Palma, Ph.D., Contributing Editor Pharmaceutical manufacturers are struggling to make sense of the data that surrounds them. This challenge starts with determining what to measure, how to measure it and how regulators will react. Those on the cutting edge envision a system in which process analytical technologies (PAT), automation and process control combine to improve product quality and work processes. That day may still be far off, but drug manufacturers have enthusiastically adopted data systems for tracking material from the ingredient stage through finished, packaged product. Material tracking is regulated, but nowhere as comprehensively as production processes, since ingredients and equipment do not come into direct contact with people. Consequently, manufacturers can apply best software, hardware and work practices from other industries and expect little to no regulatory fallout. “We were drowning in data, and starving for knowledge,” says Phil Geisler, director of information management at DPT Laboratories (San Antonio, Texas), a mid-sized contract manufacturer of solid, semi-solid, and liquid dosage forms, describing the situation that existed before the company implemented enterprise resource planning (ERP) software eight years ago. DPT used to rely on manual data input into orphan or off-the-shelf applications like Microsoft Excel. ERP helped DPT manage raw materials and ingredients, resource costs, and multiple formulas for a single product while keeping track of costs and best practices, all within the confines of applicable regulations (e.g., GLPs, cGMPs, 21 CFR Part 11). The ERP system served admirably as a data repository, but was inadequate for the company’s reportwriting and project-specific tasks. As ingredients, intermediates and products are traced through production. DPT’s quality departments rely on Millennium software from Waters (Milford, Mass.), which controls and stores data generated by chromatography systems. The ERP system then archives material “footprints” generated by Millennium for regulatory and general record-keeping. When