Faramarz Kolivand | Apr 23, 2020
About the Task Force
Task Force Members:
- Adam Caruso, Merck & Co. Inc., Kenilworth, NJ, USA
- Anil Sawant (chair), PhD, Merck & Co. Inc., Kenilworth, NJ, USA
- Callum Chapman, AstraZeneca
- Denise DiGiulio, Johnson & Johnson
- Dennis E. Guilfoyle, PhD, Johnson & Johnson
- Jim Polarine, Steris Corp.
- Karin Baer, Boehringer Ingelheim
- Lynn A. Bottone, Pfizer
- Madison Hoal, Ecolab
- Martina Kopp, Amgen
- Mary Oates, PhD, Lachman Consultant Services Inc.
- Niraj Mehta, PhD, Merck & Co. Inc., Kenilworth, NJ, USA
- Tom Cosgrove, Partner, Covington & Burling
- Thomas R. Kreil, PhD, Global Pathogen Safety, Takeda
- Tony Cundell, PhD, Microbiological Consulting, LLC, Scarsdale, NY, USA
- Wendy Stanford, GlaxoSmithKline
Task force has formed and has started its work.
Task Force Focus:
This Task Force is focusing on actions that are recommended to ensure the continued manufacturing and supply of product during an active outbreak.
- The task force will develop suggested actions on GMP processes and controls that proactively take into account the potential for viral outbreaks as it relates to manufacturing to ensure continued as well as increased supply demand for pharmaceutical products.
- The task force will provide comments to new and existing regulatory guidance as well as identify where new guidance may be needed to ensure that the enormous surges in the demand for pharmaceutical products that occur under these circumstances can be managed effectively to the greatest extent possible.
The deliverables identified by the task force include:
- Industry Survey on Impact of COVID-19 to Manufacturing Operations.
(Action completed, link below)
- Initial Publication on COVID-19 covering the virus and specific areas that should be considered related to manufacturing operations.
PDA COVID-19 Pandemic Industry Survey Results
Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic.
- Webinars specific to consideration for manufacturing and supply chain operations.
- May 27, 2020 - Impact of the COVID-19 Pandemic on the Pharmaceutical Supplu Chain (Basic Overview)
- June 29, 2020 - Remote Assessments and Inspections during the COVID-19 Pandemic: Regulator Perspectives (View Slides) (June 29 Webinar Notes)
- July 30, 2020 - Remote Assessments and Inspections during the COVID-19 Pandemic: Industry Perspectives (View Slides)
- August 24, 2020 - Applying the new June 2020 FDA Guidance on Responding to COVID-19 Infection in Employees in Manufacturing (View Slides)
- September 23, 2020 - Utilization of Modular Manufacturing to Enhance/Upscale Capacity During Covid-19 (View Slides)
- Commenting on new and existing regulatory guidance as well as proposing were new guidance may be needed.
- Development of a PDA Points to Consider document focused on preparing for and responding to a pandemic in regards to manufacturing and supply chain operations.
(Not yet initiated)