Search results for " ISPE"

Article ISPE Releases Cleaning Validation Guide
The explanatory and hands-on guidance is available to be purchased online, along with ISPE’s other resources. Source: ISPE

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle. With the most recent FDA …

Article Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
The authors re-examine environmental controls in the context of technical advances in manufacturing.  By Simon Chalk, Scott Probst, Paul Gil, Tim Palberg, Matt Kennedy, Joe Rogalewicz, Jeff Johns…

Article Advancing Single-Use Technology Through Collaboration
…by regulators in the future, by putting in effort now through groups such as BPOG, ASTM, ASME, BPSA, ISPE, and PDA. I think there’s increased recognition that it’s not ‘us’ and ‘them,’ but it’s a com…

Article Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API. By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…

Article Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions. Few FDA officials discuss pharmaceutical regulation these days without …

Article Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle. A…

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology. By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…

Resource International Society for Pharmaceutical Engineering
Founded in 1980, today ISPE serves 25,000 members in 90 countries.

Poster FlexFactory™ Automation
FlexFactory Automation is developed and verified to enable efficient design of facilities for development and manufacturing of biopharmaceuticals. This automation platform is the foundation of th…

Next Page