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Important Announcement

PDA Coronavirus Task Force

 

Coronavirus Pandemic Response Task Force

Apr 23, 2020

Task Force Leader:

Anil Sawant, PhD
Sr. VP of Global Quality Compliance, Merck & Co., Member of PDA Board of Directors

Current Status:

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. 

Deliverables/Status:

The deliverables identified by the task force include:

  • Industry Survey on Impact of Coronavirus to Manufacturing Operations
    (In-process, survey to close this week with readout expected by the first week in May)
  • Initial Publication on Coronavirus covering the virus and specific areas that should be considered related to manufacturing operations
    (In-process, initial draft completed)
  • Webinars specific to consideration for manufacturing and supply chain operations
    (Planning and scheduling initiated)
  • Commenting on new and existing regulatory guidance as well as proposing were new guidance may be needed.
    (Not yet initiated)
  • 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)