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U.S. Department of Health and Human Services

About FDA

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Selected Publications

FDA 2011 Process Validation Guidance: Process Validation Revisited
By Paula Katz and Cliff Campbell
FDA 2011 Process Validation Guidance: Process Validation Revisited (PDF - 436KB)
Journal of GXP Compliance (Autumn 2012)
With permission from IVT disclaimer icon 


PQRI-FDA Summary on Process Drift: Detection Measurement and Control in Pharma Manufacturing

By Margaret M. Szymczak, Richard L. Friedman, Rajendra Uppoor, and Avraham Yacobi
PQRI-FDA Summary on Process Drift (PDF - 4KB)
Pharmaceutical Technology (Oct 2011)
With permission from PharmTech disclaimer icon  


Burkholderia cepacia: This Decision Is Overdue

Lynn Torbeck, Diane Raccasi, Dennis E. Guilfoyle, Richard L. Friedman, and David Hussong
PDA J Pharm Sci Technol (Sep/Oct 2011);65 535-543
Burkholderia cepacia: This Decision Is Overdue (PDF – 285KB)
With permission from PDA disclaimer icon

 
Case Studies of Microbial Contamination in Biologic Product Manufacturing
Kalavati Suvarna, Anastasia Lolas, Patricia Hughes, & Richard L Friedman
Case Studies of Microbial Contamination in Biologic Product Manufacturing (PDF – 9MB)
American Pharmaceutical Review (Jan/Feb 2011)
With permission from APR disclaimer icon
 

Protecting the Public’s Health Through the Application Integrity Policy
Paula Katz
Protecting the Public’s Health Through the Application Integrity Policy (PDF - 430KB)
Food and Drug Law Journal disclaimer icon
Volume 65, Issue 3 (2010)
With permission from FDLI disclaimer icon
 

Process Robustness - A PQRI White Paper 
By PQRI Workgroup Members: Michael Glodek, Merck & Co.; Stephen Liebowitz, Bristol-Myers Squibb; Randal McCarthy, Schering Plough; Grace McNally, FDA; Cynthia Oksanen, Pfizer; Thomas Schultz, Johnson & Johnson; Mani Sundararajan, AstraZeneca; Rod Vorkapich, Bayer Healthcare; Kimberly Vukovinsky, Pfizer; Chris Watts, FDA; and George Millili, Johnson & Johnson - Mentor
Process Robustness - A PQRI White Paper (PDF - 330KB)
Pharmaceutical Engineering (Nov/Dec 2006, Vol. 26 No. 6)
With permission from PQRI disclaimer icon
 

Elicitation of Expert Knowledge about Risks Associated with Pharmaceutical Manufacturing Processes
By Dr. Nga L. Tran, Brian Hasselbalch, Dr. Kara Morgan, and Dr. Gregg Claycamp
Elicitation of Expert Knowledge about Risks Associated with Pharmaceutical Manufacturing Processes (PDF - 390KB)
Pharmaceutical Engineering (Jul/Aug 2005, Vol. 25 No. 4)
With Permission from ISPE disclaimer icon 
 

Aseptic Processing Contamination Case Studies and the Pharmaceutical Quality System
Richard L Friedman
Aseptic Processing Contamination Case Studies and the Pharmaceutical Quality System (PDF - 194KB)(Mar/Apr 2005)
With permission from PDA disclaimer icon