Presented at: 2014 IACP Conference
Authors: Cara Plese, Emily Landsperger, David Exline
Release Date: October 2014
Presented at: 2014 ASSA International IWPCPS-16 Workshops
Author: Oksana Olkhovyk
Release Date: June 16, 2014
PITTSBURGH, June 12th, 2014 — Gateway Analytical announced today that they will be presenting a poster session that focused on using Raman Imaging for chemically specific characterization of Combination Dry Powder Inhalers at the Sixteenth International Workshop on Physical Characterization of Pharmaceutical Solids (IWPCPS®-16), June 16-19th in Prague, Czech Republic.
While communication is not the sole responsibility of the quality department, it certainly plays a large role in the management and execution of an effective quality system. Even for the most organized and well documented quality system, successful communication is a must. Although I have discussed effective communication in the past, I want to focus on written communication. In the day and age of texting and social media, it seems as though with all of means for personal interface that we would become better at communication. However, I have noticed when it comes to thorough and precise written communication, it now seems to be a coveted skill rather than an inherent capability.
PITTSBURGH, June 2nd, 2014 — Gateway Analytical announced today that they will be exhibiting at the 3rd Annual ISPE-FDA CGMP Conference in Baltimore, Maryland, June 2-4th. The ISPE-FDA CGMP Conference promotes and presents the latest topics in different areas of the pharmaceutical industry including quality, innovation, technology and regulatory affairs. At this event, attendees and exhibitors benefit from having direct interaction and discussions with the FDA and leading experts in the areas of drug development and manufacturing.
Overview
Glass delamination if not discovered early can be big problem for pharmaceutical manufacturers. It has the potential to cause costly product recalls and investigations. Because of this, the FDA highly recommends that manufacturers perform stability studies to evaluate the interaction of the drug formulation with the glass vial in addition to pretesting analysis on smaller batches of the product before going into full production.
Presented at: Respiratory Drug Delivery (RDD) 2014
Authors: O Olkhovyk1, Diem Ngo 2 and William Doub 2
1. Gateway Analytical, 5316 William Flynn Highway, Gibsonia, PA 15044
2. FDA/CDER/Division of Pharmaceutical Analysis, St. Louis , MO
Release Date: Monday, May 5, 2014
PITTSBURGH, April 24th, 2014 — Gateway Analytical announced today that they will be exhibiting and presenting at the upcoming Respiratory Drug Delivery (RDD) conference in Fajardo, Puerto Rico, May 4-8. RDD is an international conference that features in-depth presentations and discussions focused on the latest development in respiratory drug delivery science, in addition to industry networking. During the conference Gateway will be promoting their unique Raman chemical imaging services that provide drug developers with truly chemically specific particle characterization. This chemical specificity is the key to understanding the extend of agglomerations in orally inhaled drug products (OINDPs), which is critical for safety, stability and FDA submission.
PITTSBURGH, March, 11th, 2014 — Gateway Analytical announced today that they have collaborated with researchers from the Division of Pharmaceutical Analysis at the Food and Drug Administration’s Drug Evaluation and Research Center (FDA/CDER) to present new findings on temperature-mediated agglomeration assessment in Orally Inhaled and Nasal Drug Products (OINDP’s) at the upcoming Respiratory Drug Delivery (RDD) conference in Fajardo, Puerto Rico, May 4-8, 2014.