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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 the batch is complete, ERP does the accounting for productivity, waste, material and labor utilization, and other metrics of process economics. For reports, DPT turns to Crystal Reports, an enterprise reporting module from Business Objects (San Jose, Calif.).
DPT differs from most pharmaceutical manufacturers in how it shares ERP data and generates reports from it, allowing employees, rather than an IT person, to delve in and mine the system for data most important to their specific functional area. The result has not been chaos, as was feared, but improved report quality, Geisler says.
However, DPT still enters data, including variables related to manufacturing, manually, through terminals hard-wired to the IT system. The company uses some sensors and automated recorders for environmental measurements, but operators still punch values into terminals. Scanning, sensing and wireless devices aren’t being used today, but their implementation is probably inevitable, Geisler says.
The day when static data (such as locations and numbers of objects) can be combined with dynamic data (such as temperature, pressure) is not far away, predicts Tracy Hillstrom, group manager for data capture systems at Intermec (Everett, Wash.). “It’s not too much of a stretch to imagine a combined temperature sensor embedded in a bar code or RFID device, where all the temperature data is accessible wherever the product may be.”
She adds, “You may need to measure a product’s temperature constantly as it works its way through the process. The data are captured periodically, shot through to a host system, and stored as part of the batch record.”
Intermec develops automated data collection systems based on one- and two-dimensional bar coding, and radiofrequency identification (RFID) tags for manufacturing, transportation and logistics.
The company introduced two advanced data products about six months ago: the Windows-powered CV30 fixed-mount computer and the EL10 scan engine. Enabled with Bluetooth and Wi-Fi networking capability, the CV30 serves as a data entry or access point, either at fixed locations in manufacturing suites or on machinery such as trucks or forklifts. According to Intermec, the EL10 scan engine is the first data-entry device for supply chain management that employs micro-electro-mechanical systems (MEMS) to facilitate data capture. MEMS are routinely employed in sensors that measure acidity, temperature, pressure and acceleration (as in vehicle impact bags). Here, the MEMS components – highly polished silicon structures that are part mirror, part semiconductor – guide the scan line for a bar code reading device.
“A good deal of data are still entered manually, but the trend is towards more automation and integration,” observes Steven Cagle, a vice president at Sparta Systems (Holmdel, N.J.). Sparta sells the TrackWise Enterprise Process Management product, whose modules include packages for quality, document management and regulatory affairs.
Mainly designed to eliminate paperbased processes, TrackWise improves process control by eliminating errors and streamlining workflow through rapid information retrieval. TrackWise also integrates with ERP, MES, environmental and laboratory information management systems (LIMS); the system is being used by drug companies that include AstraZeneca, Bayer, Forest Laboratories, Roche and Novartis.
Supervisors may enter production deviations or information may be generated by MES, ERP or environmental monitoring systems. The quality system then evaluates the deviation and performs root-cause analysis. Data can be entered in a number of ways, but at this point, Cagle says, most companies are doing it manually.
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