Search results for " PDA" in Articles / App Notes
Article
Quality by Design and Extractable and Leachable Testing
Swanson, PDA J. Pharm. Sci. Technol. 64 (6) 527-535 (Nov-Dec 2010).
ALL FIGURES ARE COURTESY OF THE AUTHOR
About the Author: Anthony Grilli is owner of FOCUS Scientific Services, a cGMP cons…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth.
Jan 01, 2015
By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…
Article
Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…
Article
Application of Quality by Design to Viral Safety
Nims, PDA J. Pharm. Sci. Technol. 64, 481-485 (2010).
5. D. Onions and J. Kolman, Biologicals, 38:377-380 (2010).
6. M. Schleh, B. Lawrence, T. Park et al., Am. Pharm Rev., 13, 72-76 (2010).
…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
Article
Regulatory Challenges in the QbD Paradigm
It's no wonder that "Supply Chain Management," "Accountability in a Global Environment," "Foreign Inspections," and "International Compliance" were some of the key sessions at the 2011 PDA/ FDA Joint …
Article
The Lifecycle Change of Process Validation and Analytical Testing
Read More About Process Validation in this PDA Tech Report for Biocleaning Cleaning Validation.