Welcome to Pharmaceutical Processing’s first issue of 2019! As you saw in our November/December 2018 issue, our publication has taken on an exciting new digital format to allow our readers to easily browse our content and read about vital issues encountered by pharmaceutical manufacturers, suppliers and distributors.
In this issue, we bring you information about how spray dried dispersions at risk for crystallization, and how crucial it is for them to be properly characterized—all the while, maintaining a sufficient understanding of the impact of process conditions on the dispersion properties. We also invite you to read about how large, single product-dedicated brick and mortar facilities are giving way to multiple product versatile facilities, and what this means for the future of the modular manufacturing community. We also interviewed an expert associated with an Irish pharmaceutical facility, who discussed the updates and changes that were necessary in order to accommodate new trends in pharmaceutical research.
We are also excited to add a new column to Pharmaceutical Processing—“Regulatory Forum,” written by Bikash Chatterjee of Pharmatech Associates. Bikash has over 30 years’ experience in site selection, project management, design and validation of facilities for U.S. and European regulatory requirements. His column will present updates to FDA standards and regulations, and discuss important news in the pharmaceutical industry. This issue’s topic relates to the FDA’s priority review voucher system.
Regulatory Forum was previously included in Pharmaceutical Processing’s sister brand, Controlled Environments, which is now a part of this publication. Read through the magazine to learn more about this exciting merger.
We welcome your comments and input, and editorial contributions as well. Here’s to a great 2019!
MaryBeth DiDonna
Editor, Controlled Environments
