Operations Spotlight: On the Raw Materials Department
Travis Emig, Senior Director, Pharmaceutical Chemistry
The Eurofins Lancaster Laboratories Raw Materials Department in Lancaster, PA, has experienced tremendous growth. At present, the team is comprised of nearly 80 scientists. Full analytical coverage includes two shifts plus a dozen operation leaders.
This department supports a wide variety of activities, including full compendia testing for USP, EP and JP requirements, water chemistry, API and reference standard qualification, trace metals and residual solvent determinations. Newer services offered include XRPD identification and trace metals testing conducted in a controlled clean room environment.
Reasons for demand increases include several common themes found in the pharmaceutical industry today. Headcount restrictions, changes in published compendia, QC units required to qualify their ability to successfully execute test methods in their respective laboratory environments, and CMO operations that do not possess full technology capabilities are many of the drivers leading to increased outsourcing decisions.
Our team has focused on establishing an efficient organizational structure, including numerous process controls that allow for high quality testing to be performed with maximum productivity and attention to delivery deadlines. In 2012, the department was divided into two unique groups: one supporting the assessment, installation and qualification of all analytical procedures not previously run at our facility; the other focused on release testing using established methods with a single objective to meet delivery commitments. In 2013, we aligned a dedicated team of data review specialists focusing entirely on this department.
So what’s our strategy to sustain further growth in this area?
The continued addition of staff and expansion of our current laboratory footprint is ongoing. Eurofins Lancaster Laboratories is projecting to staff nearly 100 individuals in this department by the end of 2014.
A dedicated sample receipt team with extensive compendia based experience has been established to support quick and accurate entry of samples and analyses into our LIMS system. This group will quickly resolve any discrepancies with information from customers prior to analytical work commencing.
We will work diligently with customers in strategic ways. We have identified quick wins with such initiatives as requesting potential lists of materials that may be coming to our facility from a customer, and we in turn pre-stock items such as compendia standards (especially EP and JP specific materials) so delays from supply chain roadblocks and customs are mitigated. Specific technical management oversight of fully outsourced customer programs and having communication channels for knowing when shipments are processed have allowed pre-staging activities for samples en route to our facility. Our staff understands manufacturing operations today are often “Just in Time” processes, timelines are short, emergencies occur, and we rally our staff to meet those demands. We attempt to arrange discussions with new customers prior to samples being submitted to our facility as an on-boarding effort, establishing clear understanding of our processes and full disclosure of how we operate as well as what to expect from us.
Moving forward, Electronic Notebooks (ELN) will pave the way to immediate review and release of data once testing is complete. Significant efforts are being made to roll out ELN processes into this operation in 2014.
Our objectives are to provide released reports for testing that has been established at our site in eight business days (shorter than industry standards of 10 business days). We are striving to provide manufacturing support and accept realistic rush requests as frequently as needed. We specialize in method establishment, method development and consulting on the performance and reliability of compendia methods. We will continue to engage our customers and strive to become an extension of their organization.
For more information, contact Pharmaceutical Business Development.