Forth Worth, Texas (PRWEB) May 26, 2006 –-
ThinSpring, a leading provider of XML-based solutions such as SPL Server™ and the FDA’s Electronic Labeling Information Processing System (ELIPS), has presented “SPL Downstream – XML Content and Final Package Labeling” to the Pharmaceutical Packaging And Labeling Committee (PP&LC). The presentation was given by Ron Celeste, CEO of ThinSpring, on May 8, 2006, in Forth Worth, Texas.
Structure Product Labeling (SPL) and Product Information Management (PIM) deal specifically with the submission of labeling content to the regulatory authorities for approval. Once that content has been approved, the PP&LC members need it to produce the physical labeling that goes on the drug product containers, inner cartons, outer cartons, and shipping containers. XML data file formats are new to this community, and there is a need to focus on style and presentation. Packaging engineers have to consider challenges such as an aging population and a novel design for single dose packaging. They are used to working with binary file formats such as Quark, Illustrator, PDF, and encapsulated post script. The presentation addressed the concept of using one XML-based content repository to serve multiple purposes including regulatory submission and finished package labeling. This transition requires an initial focus on education, training and process redesign.
The United States Food and Drug Administration (FDA) currently uses ELIPS as a part of the process to internally validate SPL submissions from pharmaceutical manufacturers. The FDA made SPL mandatory as of November 3, 2005. Shortly after that in December of 2005, the European Medicines Agency (EMEA) saw the first use of its PIM system.
For more information, go to the ThinSpring website or contact Ron Celeste at (908) 595-2145. For access to the presentation, go to the ThinSpring website and click on “Request Access to PP&LC Presentation.”
ThinSpring, founded by former pharmaceutical and medical device professionals, specializes in XML-based Web service solutions, integration and data conversion. ThinSpring has used its industry expertise to develop a dynamic XML engine, MatriXML™. This patented XML technology is the basis for SPL Server™. ThinSpring’s solutions have gained acceptance as an essential, collaborative application-development platform for FDA regulated companies. ThinSpring’s core team manages technology and regulatory consulting divisions that support its clients’ operations throughout the United States, Europe, Asia and South America. ThinSpring headquarters is in Bridgewater, New Jersey, with offices in California and North Carolina. More information about ThinSpring and ThinSpring SPL Server™, can be found on their website at: http://www.ThinSpring.com.