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# Lessons from FDA Aseptic Mfg. Inspections
- URL: https://www.fdaweb.com/lessons-from-fda-aseptic-mfg-inspections/
- Published: 2022-01-05T12:00:00.000Z
- Updated: 2026-09-14T17:27:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150871

CDER senior policy advisor **Brooke Higgins** says FDA has seen inspection trends in aseptic technique and behaviors; facility, room, and process design; and the use of media fills. An online [report](https://www.healthcarepackaging.com/issues/regulatory/article/21977585/pitfalls-to-avoid-in-fda-aseptic-manufacturing-inspections?ref=fdaweb.com) in *Healthcare Packaging* covers Higgins’ presentation at the 9/2021 Parenteral Drug Association/FDA joint regulatory conference.

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

In control strategy, she said, FDA requires manufacturers to run all processes by the agency to ensure proper protection from microbiological contamination of drug products purporting to be sterile. It also insists a current good manufacturing practice-compliant firm must continually assess its systems and take action on time to ensure that it remains in a state of control, including the facility, the equipment, and the process. FDA expects companies to assess the effectiveness of controls and measures in place to minimize the risk of contamination, she said.

Areas of contamination concern Higgins discussed were personnel; facility, room, and process design; smoke studies; and media fills.

She also highlighted technologies that she said can better protect the product from contamination during aseptic processing.