PDA Papers on Particulates and PACs and PQRI Papers on Extractables Popular Reads

Below are the top ten articles from the PDA Journal of Pharmaceutical Science and Technology for the month of August.

1. Review

Stephen E. Langille “Particulate Matter in Injectable Drug Products” May/June 2013

2. PQRI Special Section – Research

Dennis Jenke, et al. “Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products” September/ October 2013

3. PDA Paper

Stan Bukofzer, et al. “Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products” January/February 2015

4. PDA Paper

Emma Ramnarine, et al. “PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Postapproval Changes” May/June 2017

5. PQRI Special Section – Review

Diane Paskiet, et al. “The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)” September/October 2013

6. Review

James Agalloco “Increasing Patient Safety by Closing the Sterile Production Gap—Part 1. Introduction” July/August 2017

7. Review

Robert A. Schaut and W. Porter Weeks “Historical Review of Glasses Used for Parenteral Packaging” July/August 2017

8. Review

James Agalloco “Increasing Patient Safety by Closing the Sterile Production Gap—Part 2. Implementation” July/August 2017

9. Review

James Agalloco “Increasing Patient Safety by Closing the Sterile Production Gap—Part 3—Moist Heat Resistance of Bioburden” July/August 2017

10. Research

Dennis Jenke, et al. “Simulated Leaching (Migration) Study for a Model Container- Closure System Applicable to Parenteral and Ophthalmic Drug Products” March/ April 2017