1. Pink Sheet
  3. >>Manufacturing

Glass-Related Drug Recalls Decline After Industry Improves Practices

 
• By Joanne S. Eglovitch

The number of sterile drug recalls from glass delamination, breakage and other sources of contamination has dropped dramatically since 2010, with the exception of several spikes in 2013 and 2014. FDA and other officials attribute the drop to better risk assessments and fuller evaluations of product formulations' interactions with container closure systems. The industry is also exploring the use of a new, reportedly sturdier type of glass vial that eliminates delamination.

Sterile bottles and ampoules on the dispensing line.Sealed ampoules with medicine.Sterile capsules for injection. Bottles on the bottling line of the pharmaceutical plant.

The pharmaceutical industry drew praise from FDA for improving glass handling practices and conducting more robust container closure studies, which appears to have reduced the number of sterile drug recalls due to glass delamination, breakage and other glass-related factors.

Pharmaceutical industry officials, representatives of the glass industry and FDA officials discussed some of the progress being made in reducing glass breakage as well some of the challenges in testing glass for potential breakage at a Jan

More from Manufacturing

More from Compliance

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.