Title: Performing Remote Audits During the Pandemic

It is important to consider the feasibility, benefits, and limitations of each type of audit in advance. Q: In light of the COVID-19 pandemic, many of our planned on-site audits can no longer be performed for the foreseeable future, and there is a need to replace these by remote (desktop) audits. Under what circumstances can such remote audits be considered equivalent to on-site audits? A: Regulatory agencies around the world are facing the same challenge of deciding when inspections can be performed remotely and when they must be performed in person. Each respective agency has its own guidelines, but across the board, they all rely on the fundamental principle of a risk-based approach to compliance.

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 325412 - Pharmaceutical Preparation Manufacturing                
Company  Product  Process  Other  Subjects  Event  Event  Date  Location  Publication  Publication  Date Text  Descriptor
  • Auditing

 

 

 

 

  • Pharmaceutical Technology

 

  • 7/1/2020

 

  • Article