REGULATORY
Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections MELISSA GRIFFEN, CONTRIBUTING EDITOR TOP THREE TAKEAWAYS 1. An FDA policy advisor provides an outline of what facilities can improve on.
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2. Despite guidance, FDA continues to find observations surrounding aseptic technique.
he 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 2021 PDA/FDA Joint Regulatory Conference, Brooke K. Higgins, MS, Senior Policy Advisor, CDER, 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 for 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 compo-
3. FDA is increasing its focus on line design review, emphasizing smoke studies.
nents, and careful and attentive interactions in the processing and surrounding areas.” Higgins emphasized that in control strategy, FDA rule requires manufacturers to run all processes by them to ensure proper protection from microbiological contamination of drug products purporting to be sterile. FDA also insists a current Good Manufacturing Practices (cGMP)-compliant firm must continually assess its systems and take action in a timely manner to ensure that it remains in a state of control—this includes the facility, equipment, and the process. FDA expects companies to assess the effectiveness of controls and measures in place to minimize the risk of contamination.
Causes of contamination Main causes of contamination in the U.S. and internationally listed in the presentation were: The personnel—Higgins said, “The major variable in the control of aseptic processing arises not from the sterilization processes,
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