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FDA Releases Guidance on Manufacturing, Supply Chain, & Drug Inspections

FDA Releases Guidance on Manufacturing, Supply Chain, & Drug Inspections

ISPE is dedicated to keeping our members up to date on the latest news and resources about COVID-19 and the ways the pharmaceutical industry is adapting to ongoing developments. One valuable resource is the Food and Drug Administration’s (FDA) question-and-answer-post, Manufacturing, Supply Chain, and Drug Inspections (COVID-19), which provides guidance on how to implement manufacturing and site changes as well as reporting to an application. The Center for Drug Evaluation and Research (CDER) is continuing drug reviews while responding to public health needs associated with the COVID-19 outbreak while the FDA continues to be adaptable and transparent.

This valuable resource covers how inspections are going to be affected due to COVID-19 and includes information on:

  • What types of inspections are considered mission critical
  • How to add or change a facility in an application due to pandemic-related supply chain disruptions
  • What data is required to support a manufacturing process or facility change
  • How to file an application that includes facilities in regions affected by pandemic travel restrictions
  • The FDA’s response to applications including facilities that cannot be inspected due to travel restrictions

During this time of uncertainty, it is more important than ever that the pharmaceutical industry be able to continue research as well as manufacturing and distribution. ISPE is here to support our members, help them continue their quest for knowledge, and provide them with ways to stay connected. Our COVID-19 (Coronavirus) Pharma Industry Resources Page has a complete list of global and local resources available to you including articles, webinars and links to industry information.