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
