New Tool: ProSource
Checkout our packaging and processing solutions finder, ProSource.
Start Your Search

Counting Down the Top 10 Articles of 2022 - #1: Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections

Join us as we look back at the most-read Healthcare Packaging stories of 2022. At #1, from personnel to facility design to process, FDA policy advisor provides an outline of what facilities can improve on.

Aseptic processing is one of the highest risk pharmaceutical operations, and thus requires a high level of control.
Aseptic processing is one of the highest risk pharmaceutical operations, and thus requires a high level of control.

The pharmaceutical industry depends greatly on cleanroom standards to ensure the health and safety of patients, especially during aseptic processes for the production of drugs purporting to be sterile. At the recent 2021 PDA/FDA Joint Regulatory Conference, Brooke K. Higgins, MS, senior policy advisor, CDER, U.S. FDA presented on recurring deficiencies and safety failures found during FDA aseptic manufacturing inspections, both in the U.S. and globally, along with possible solutions.

As aseptic processing is one of the highest risk pharmaceutical operations, there are severe consequences to lack of control. FDA’s aseptic guidance, the European Annex, and a number of other valuable resources list principles to avoid contamination events, yet FDA continues to note inspectional trends surrounding aseptic technique and behaviors; facility, room, and process design; and the use of media fills. 

“We know it takes a myriad of meticulous steps to ensure the quality of sterile drug products,” said Higgins. “This includes fastidious control over the sterile drug, container closures and components, and careful and attentive interactions in the processing and surrounding areas.”

Continue to the full article here: Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections

 

 

 

 

Discover Our Content Hub
Access Healthcare Packaging's free educational content library!
Unlock Learning Here
Discover Our Content Hub
Test Your Supply Chain Smarts
Take Healthcare Packaging's supply chain quiz to prove your knowledge!
Take Quiz
Test Your Supply Chain Smarts