FDA Gives Guidance on Manufacturing During COVID-19
The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.
On September 11, 2020, FDA published guidance to help manufacturers of drugs and biologics transition their manufacturing operations impacted by the COVID-19 pandemic back to “normal”. In the guidance, the agency provides recommendations for prioritizing products as normal operations resume and for remediation of current good manufacturing practice (CGMP) activities impacted by the pandemic.
During the pandemic, manufacturing operations may have been impacted by employee illness, travel restrictions, plant closures, and disruptions to the supply chain. The guidance provides detailed information for addressing CGMP deviations, developing a plan to resume normal manufacturing activities, and prioritizing activities. The document includes a list of examples where remediation may be necessary.
Source: FDA
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
