This Month's Feature

The Case for CDS and LIMS Integration in the Pharmaceutical Industry (continued)

Data Integration as Part of the Process Improvement With the holy grail of less FDA oversight as the ultimate prize, the question remains, "How can companies implement this new approach to pharmaceutical manufacturing?" The first way is to analyze the manufacturing equipment and process itself, but this is not the only area where the approach can be adopted. The scientific data surrounding the process is also a key area for improvement. Manufacturers should strive to eliminate any high-risk areas and use their data more effectively to make sound business decisions. This is where LIMS and CDS integration can play a critical role. Traditionally, data, like stability and dissolution results, have been acquired through the CDS, but then distilled results have been interpreted in the LIMS. Because only a subset of CDS results are transferred to the LIMS, data associated with a failed sample is somewhat lost, or at least more cumbersome to retrieve. Access to all the sample data in a single system would assist scientists in making better, faster decisions. By ensuring that the full scientific data is available with its summarized results, pharmaceutical companies can make critical business decisions confidently and ensure that they are delivering consistent quality in their products. In the event of a failure and as part of their investigation on behalf of the FDA, pharmaceutical scientists would be able to track in one system not only the original failed result, but also the actual chromatography itself. Instantly, they would be able to see if the failed data was the result of operator error or is a serious issue that would impact the quality of the product. When an FDA inspector reviewed the investigation, it would be clear that the company had taken all of the appropriate action to protect consumers. This comprehensive approach to data ensures its integrity and potentially could bolster the confidence of the FDA in the quality processes used in pharmaceutical laboratories. To take advantage of this approach, both the LIMS and CDS should be designed as commercial-off-the-shelf (COTS) solutions for pharmaceutical manufacturing. Traditional LIMS have been customized to meet the unique needs of pharmaceutical customers, while CDS have been designed traditionally to provide for the chromatography market as a whole and not to meet the demands of pharmaceutical specifically. When either system requires heavy customization, then the interface between the two systems also will have to be customized or it will no longer adequately address the needs of the business. This introduces unnecessary validation effort. Therefore, vendors intent on meeting client expectations are moving toward vertical-oriented, COTS solutions that more seamlessly integrate. In their 2003 Worldwide Outlook on Laboratory Information Management Systems, the ARC Advisory Group noted that system requirements vary widely by industry and that a vertical industry focus implies a level of proficiency on the part of the vendor that can be invaluable to a client for system implementation and validation. The ONDC's first use of the risk-based approach will most likely set the trend for further application of the cGMP guidelines on other product quality review processes, such as the investigational new drug and the postapproval supplement. It is still unclear how much this will change pharmaceutical manufacturing, but what is clear is that the FDA will be focusing its resources on high risk products and high risk manufacturers. By using modern technology and well integrated software systems, pharmaceutical manufacturers might be able to reduce their perceived risk and improve product quality. ♦