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Inspection data show visual inspection, cleaning and loading problems in lyophilization
Summary
CDER's review of 2015–2019 inspection findings shows visual inspection issues (27%), cleaning/sterilization shortcomings (23%), and loading problems (22%); the agency cited missing SOPs, inadequate training, and leak/integrity testing gaps.
In a review of inspection findings from 2015 to 2019, Steve Ryu told attendees that visual inspection issues accounted for 27% of lyophilization-related findings. He said problems included inadequate defect libraries, insufficient training for visual inspectors, and missing standard operating procedures for inspection.
Ryu also identified cleaning and sterilization lapses (23% of findings), lack of integrity testing for gas filters, inadequate leak testing of the lyophilizer chamber, and loading problems (22%) such as missing smoke studies and breaches of first air while transferring partially stoppered vials. He warned that these gaps can allow defective vials to reach patients if not addressed.
