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By linking XML-based preventive maintenance and asset management systems, pharmaceutical facilities improve time to market and slash compliance costs

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In some cases, an intelligent device provides data automatically. More often, however, an operator or maintenance engineer records and reports data using a handheld data terminal with a barcode scanner to assist with equipment identification. The technician manually enters data about the device or equipment, and he or she can analyze these data and combine them with other information for trend analysis and optimal use determination.

Plant personnel can plot trends using corrective and preventive action (CAPA) software to determine the cause or causes of equipment problems. Equipment experts subsequently can determine a strategy for correcting or preventing the problem.

Web-based access to the asset management information can further optimize equipment availability. For instance, if a common piece of equipment is being used in multiple plant locations, Web-based access to the equipment database can speed plant personnel's access to regularly observed conditions or problems and hasten preventive or corrective action. Work orders can be sent automatically to technicians when maintenance is required ," anytime, anyplace and anywhere. In essence, technicians do not have to remember to access each stand-alone system separately. Instead, the Web-based system alerts users when action is required. Work stoppages resulting from equipment failure become far less common.

By linking the preventive maintenance system to the asset management system via the Web, plants are prepared for unexpected equipment problems. If an operator or maintenance technician obtains an out-of-specification reading from a piece of equipment or a device, he or she can relay the problem to engineering maintenance via the plant's intranet. Engineering personnel then access the device, view the status of the equipment and decide whether or not batch production should continue. Without Web-enabled connectivity, the operator would have to wait for a technician to inspect the equipment physically.

Proactive asset management also helps reduce labor expenses. A maintenance technician need not go from device to device to check operating status at regular intervals. Instead, the technician need only access the intelligent devices requiring attention. The system, in essence, performs all of the monitoring.

One manufacturer recently reduced its preventive maintenance workload dramatically by capturing information about devices and equipment online and in real time.

Since the facility installed a real-time data collection and reporting system on its devices and equipment, it now plans and performs work for only the devices and/or equipment with deteriorating performance parameters. As a result, work that was focused previously on data collection and reporting now is channeled into actual replacement and repair activities before the equipment or process goes out of service or out of specification.

When plant personnel are notified of an equipment or device problem, they search a database for a specific tag number to obtain basic information such as specifications, adjustments and calibration parameters. They then interrogate the device or equipment online to assess its operating condition and determine whether to replace it or repair it ," and when.

Personnel not only troubleshoot equipment and devices from the safety and convenience of the maintenance shop, but also document their activities automatically.

Streamline compliance

Fewer unplanned work stoppages mean more product is released in a timely manner. However, to get products out the door more efficiently, pharmaceutical manufacturers also must streamline the quality review process. During this step of production operations, predictive asset management programs can be invaluable in preventing release delays resulting from equipment specification deviations.

In pharmaceutical enterprises, partial evidence of regulatory compliance is achieved through maintenance of records required by Subpart J (records and report) in FDA's Current Good Manufacturing Practices (cGMPs). Subpart J covers equipment cleaning and use logs; component and labeling records; master production and control records; batch production and control records (together with their review); laboratory records; distribution records; and complaint files. Facilities must document recipe and process compliance in all of these areas, as well as in areas not specifically called out by Subpart J, but maintained as evidence of compliance with other sections of the regulations. These related sections include personnel training records; process and system validation records and reports; standard operating procedures; analytical methods; and material specifications.

The challenge is to access and report the combination of all data to maintain compliance with regulations. Typically, facilities must maintain written process control procedures, records and related documents for inspection. The quality assurance department must review a representation of these records ," the batch record ," before the product is released or distributed. To put together a batch record, plant personnel might be required to piece together a couple of pages ," or to assemble a document that is hundreds or thousands of pages long. Electronic data collection, reporting and presentation can save thousands of dollars annually and reduce time spent manually on data collection and review.

An electronic version of this information also is very helpful for search and retrieval purposes because the batch record includes all information and records used to control batch execution. An electronic batch record then can be reviewed and released faster.

Naturally, fewer equipment-related work stoppages translate into easier compliance with recipes and regulations. If equipment is functioning at optimal levels, less documentation about equipment failures and resolutions is needed.

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