Search results for " ISPE" in Articles / App Notes
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 …
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Creativity and collaboration are required to overcome complex method development challenges.
By Kelvin H. Lee and Mark Lies
…
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…
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Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing.
By Cynthia A. Challener
Vaccine development is a complicated process that can take many yea…
Article
Breakthrough Drugs Raise Development and Production Challenges
…ug Products in CDER’s Office of Pharmaceutical Quality (OPQ), at the DIA workshop and again at the ISPE/FDA/PQRI Quality Manufacturing Conference in June 2015. Matecka noted that CDER will schedule C…