PPD COP Articles

Pharmaceutical Engineering Articles

Articles published in Pharmaceutical Engineering, ISPE’s bi-monthly member magazine that relate to the subject matter of the PPD COP.

• Engineering Practices During Manufacturing Process Development for New Products
  March/April 2013, 33(2)
  by David Rich, Mark Blanchard, Salvatore Giglia, Greg Straeffer, Amy Cazeault, Shannon Cleveland, Rebecca Bartkus, and Matthew Desmarais
• The U.S. Pharmacopeia (USP) Responds to Changing Needs of Pharmaceutical Manufacturing
  March/April 2012, 32(2)
  by Anthony DeStefano, Antonio Hernandez-Cardosa, Kevin Moore, Tina Morris, Horacio Pappa, and Radhakrishna Tirumalai
• A Holistic Approach to Pharmaceutical Manufacturing: Product Lifecycle Management Support for High Yield Processes to Make Safe and Effective Drugs
  March/April 2012, 32(2)
  by Julie Fraser and Guillaume Kerboul
• Biopharmaceutical Manufacturing in the Twenty-First Century – the Next Generation Manufacturing Facility
  March/April 2012, 32(2)
  by Mark F. Witcher, PhD and Jeff Odum CPIP
• Risk Analysis and Mitigation Matrix (RAMM) – A Risk Tool for Quality Management
  January/February 2012, 32(1)
  by Alex Brindle, Steve Davy, David Tiffany, and Chris Watts
• Using Operational Excellence to Meet the New Process Validation Guidance
  September/October 2011, 31(5)
  by Bikash Chatterjee, Peter Rafa, and Wai Wong
• Industry Interview Series: Grace McNally, Senior Policy Advisor, FDA CDER Office of Compliance, Division of Manufacturing and Product Quality ( 328 KB)
  July/August 2011, 31(4)
  by Rochelle Runas, ISPE Technical Writer
• A Systematic and Scientific Approach for Implementation and Validation of Single-Use Equipment ( 5 MB)
  May/June 2011, 31(3)
  by Jean-Loup Descamps, Jean-Baptiste Milandri, and Peggy Sander
• Practical Application of Quality Risk Management to the Filling Process of Betamethasone Injections ( 6 MB)
  May/June 2011, 31(3)
  by Rodolfo Díaz, Germán Fernández Otero, and Cristian Muzzio
• Optimizing the Design and Operation of Fill-Finish Facilities using Process Simulation and Scheduling Tools ( 7 MB)
  March/April 2011, 31(2)
  by Demetri Petrides, Charles Siletti, José Jiménez, Petros Psathas, and Yvonne Mannion
• Continuous Verification – Providing an Alternative Approach to Process Validation ( 2 MB)
  January/February 2011, 31(1)
  by Richard Kettlewell, John Upfield, Rosemary Leak, and Andrew Harris
• The Challenges of Regulatory Change Management: Does ICH Quality Trio Provide the Solution? ( 863 KB)
  January/February 2011, 31(1)
  by Mary Oates, Michael Marini, and Barry McCloy
• Process Transfer to Contract Manufacturing Organizations: A Case Study on Process Development Support Past Regulatory Approval ( 3 MB)
  July/August 2010, 30(4)
  by Amy Webb, David H. Reifsnyder, and Jean Bender
• Simple Strategies to Improve Bioprocess Pure Culture Processing ( 2 MB)
  May/June 2010, 30(3)
  by Michael Hines, Chris Holmes, and Ryan Schad
• PQLI Roadmap: Product Design, Development, and Realization, a Science- and Risk-Based Approach to Implementation – An Overview of ISPE’s First PQLI Guide ( 3 MB)
  March/April 2010, 30(2)
  by Dr. Christopher Potter, Dr. John Berridge, Contributing Team
• A Simplified Statistical Model to Assess Product Capability ( 2 MB)
  March/April 2010, 30(2)
  by Mr. Selim Seyhan, Mr. Tolga Ozcan, Mrs. Merve Oktem
• Microreactor Technology: Innovations in Production Processes ( 10 MB)
  January/February 2010, 30(1)
  by Dr. Yukako Asano, Togashi Shigenori, Tsudome Hidekazu, Sei Murakami
• The FDA’s Draft Process Validation Guidance – A Perspective from Industry ( 2 MB)
  May/June 2009, 29(3)
  by Nuala Calnan , Alice Redmond, and Stan O’Neill
• The Draft Process Validation Guidance – A Perspective from the FDA ( 2 MB)
  May/June 2009, 29(3)
  This article presents the questions and answers from a recent ISPE Webinar focused on the FDA’s draft process validation guidance.

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