In 2011, FDA issued an advisory to drug manufacturers regarding the potential formation of glass lamellae (glass fragments) in injectable drugs filled in small-volume glass vials. The advisory noted that the Agency was drawing attention to the issue because of several drug recalls in 2010 and 2011 due to the problem. The advisory also noted that there were no known adverse events reported or directly attributed to the problem; however, glass lamellae in injectable drug products pose potential risks, particularly when drugs are administered intravenously. The advisory noted that a number of conditions have been associated with a higher incidence of formation of glass lamellae in drug products including, among other factors, glass vials manufactured by the tubing process at higher heat, drug solutions formulated at high pH, the duration of time the drug product is in contact with the glass container, and terminal sterilization processes. The advisory also provided recommendations to h See full list on fda.gov The Agency evaluated surveillance data to determine whether there were any new or emerging safety signals related to quality issues associated with glass containers used in drug products on the market. FDA analyzed surveillance data from FY 2008 through FY2017. A new safety signal or change in frequency of reports of a known safety concern could reflect the emergence of an issue that would warrant a new or updated advisory by the Agency in order to inform manufacturers. However, FDA’s analysis of available data did not identify any new or increasing safety signals since the advisory was issued in 2011. At a recent glass quality conference with presentations by FDA and industry experts, participants noted progress has been made in improving glass quality for pharmaceutical packaging.2Given this trend and the lack of any new safety signals related to glass quality issues, FDA will not update the 2011 advisory at this time. FDA will continue to monitor drug quality, evaluate and assess... See full list on fda.gov In addition to evaluating surveillance data, FDA has also been engaging companies that have been working on developing new glass designs for use in pharmaceutical containers with a goal of addressing quality issues such as the formation of glass lamellae. Companies have approached FDA’s Emerging Technology Program (ETP)3with requests to discuss their glass designs. The ETP promotes the adoption of innovative approaches to pharmaceutical product design and manufacturing through early engagement, and the ETP provides feedback on proposed technologies to facilitate anticipated regulatory submissions. Early engagement gives FDA reviewers a better understanding of a new technology when it comes in for review or is referenced in a submission. ETP’s role is to review a technology on its merits, not to endorse a company’s technology. Each technology still has to be evaluated in the context of the regulatory submission that it is associated with. At the request of the ETP, the Office of Phar... See full list on fda.gov
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