In two articles published in the January/February 2014 and September/October 2014Pharmaceutical Engineering magazine, the GAMP® Cloud Special Interest Group (SIG) provided an overview of some of the primary challenges and concerns regarding whether cloud solutions can be adopted, as well as the specific challenges related to the Infrastructure as a Service (IaaS) delivery model. The GAMP® Cloud Special Interest Group has now created three companion Concept Papers covering the topics:
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has recently announced the adoption of the revised guideline
The outlook for the biopharmaceutical market is promising, with expectations that the market will double in the next 10 years, resulting in new therapies and advances in biopharmaceutical manufacturing. This doesn't sound like much at first, but if you consider how the market has developed over the last 20 years, a doubling in the next 10 years is very significant.
The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.