In 2004, the FDA launched the Critical Path Initiative as a national strategy to drive innovation in development, evaluation and manufacturing of medical products1. As part of this initiative, the FDA identified a number of Critical Path Opportunities (CPOs) for generic drugs. Namely the CPO for Bioequivalence of Nasal Sprays, which identifies a need for direct measurement of particle size equivalence in suspension nasal sprays2.
Method validation is the process of demonstrating that the performance characteristics of an analytical method meet the requirements of the intended use and extended range of interest. Although the parameters may vary depending on the type of the method to be validated, common validation elements that need to be considered are:
Two Gateway Analytical scientists (David Exline and Ryan Priore) have volunteered to take part in the advisory committee for the Science, Technology, Engineering, Arts, and Mathematics (STEAM) program in the Pine Richland School District. The intention of this committee is to combine the talents and interests of the community to best support students within the Pine-Richland School District. This group will meet periodically to discuss our focus on STEAM at both the elementary and secondary grade levels within the school district. Discussions during our advisory committee meetings will focus on corporate outreach and partnerships, building student interest in STEAM education and future careers, and hands-on classroom applications of STEAM curriculum.
I'm excited to say that Gateway Analytical is one step closer to achieving its 2012 goal of ASLCD/LAB accreditation for our forensic trace evidence analysis services. We've submitted the required application materials including the Quality Management System Manual, Statement of Qualifications (SOQs), and Standard Operating Procedures (SOPs), among others, which have been accepted by the assigned assessor and we are now undergoing a document gap analysis. We expect our certification audit to be in May or June and look forward to meeting our goal of ASCLD/LAB accreditation in late Q3 or early Q4!
Last week at PITTCON, Gateway Analytical scientists, Dr. Ryan J. Priore and Dr. Oksana Olkhovyk, presented in the Pharmaceutical - LC, GC and Raman session on the validation of Ingredient-Specific Particle Sizing (ISPS) for nasal suspension products using Raman Chemical Imaging (RCI).
On Feb 7th, 2012 Gateway Analytical hosted a live webinar titled “Forensic Gunshot Residue Analysis for Police & Attorneys”. During the webinar our presenters, David Exline and Cara Plese, discussed what gunshot residue (GSR) is, how to collect it and control contamination, the historical and current methods of analytical testing of GSR, as well as a discussion on how terminology in the GSR community has changed and why.