PDA Journal of Pharmaceutical Science and Technology: 71 (3)

May/June 2017; Volume 71,Issue 3

Editorial

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Why is There a Problem with Data Integrity?
Christopher J. Smalley

PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 170-171; DOI: https://doi.org/10.5731/pdajpst.2017.001101

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Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress
Benson Gikanga, Devon Roshan Eisner, Robert Ovadia, Eric S. Day, Oliver B. Stauch and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 172-188; DOI: https://doi.org/10.5731/pdajpst.2016.006726
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Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities
Fernando A. Garcia and Michael W. Vandiver

PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 189-205; DOI: https://doi.org/10.5731/pdajpst.2016.006882
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Validation of Milliflex^® Quantum for Bioburden Testing of Pharmaceutical Products
Oliver Gordon, Marcel Goverde, Alexandra Staerk and David Roesti

PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 206-224; DOI: https://doi.org/10.5731/pdajpst.2016.007450

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Proper Accounting for Surface Area to Solution Volume Ratios in Exaggerated Extractions
Dennis R. Jenke and Barrett E. Rabinow

PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 225-233; DOI: https://doi.org/10.5731/pdajpst.2016.007195

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Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study
Ildikó Ziegler, Judit Borbély-Jakab, Lilla Sugó and Réka J. Kovács

PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 234-244; DOI: https://doi.org/10.5731/pdajpst.2016.007096

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Quantitative Microbial Risk Assessment of Pharmaceutical Products
Mostafa Essam Eissa

PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 245-251; DOI: https://doi.org/10.5731/pdajpst.2016.007047

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PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther

PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575