Quality, Environmental Health & Safety and compliance

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Committed to achieving world-class safety performance

At Alcami, we are committed to achieving world-class safety performance. In 2015, we demonstrated this commitment to operational excellence by implementing strategies that resulted in a total recordable injury rate (TRIR) of 1.38 (industry average: 2.1) and a reduction in our Lost Time injury rate (LTIR) of 0.2 (industry average: 0.8), well below the pharmaceutical industry average.

We meet all applicable local, state and federal regulatory requirements, including current GMPs and country guidelines for the U.S., Canada, EU and EU Member State regulatory bodies (e.g., EMA, MPA, IMB). We also incorporate international standards as part of the Quality Management System and meet expectations established by the USP, EP and JP. We comply with all regulations and standards, including those regarding controlled substances (DEA), radioactive materials (NRC), environmental protection (EPA), child-resistant container-closures (CPSC) and employee safety (OSHA).

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View our EH&S Policy 

 


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A Message from Dr. Stephan Kutzer, CEO, President and Chairman of Alcami Corporation

In late 2016, a scientific article reporting the presence of perfluorinated contaminants in the Cape Fear River Watershed of North Carolina was published, indicating the public water supply was contaminated with a chemical called GenX – a potentially cancer-causing substance that is a byproduct of DuPont and Chemours manufacturing processes. These findings were brought to the public’s attention in early June 2017 by a press article in the Wilmington Star News.

Alcami is following all local and state guidelines regarding personal consumption of the water supply. We proactively conducted an internal risk assessment which indicated exposure to the contamination via drug product manufacturing is of de minimis risk.

The safety of our employees and the products we manufacture for our clients are of utmost importance and we take this matter very seriously. We will continue to monitor the situation and will maintain all of the proper precautionary measures at our Wilmington facility.