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On 28 November 2025 US President Obama signed the Drug Quality and Security Act into US law.
This Act addresses one of the omissions from FDASIA; the tracking of drug products in the USA. This new law immediately pre-empts all state laws concerning drug product track and trace, including Cali...
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On 5 November 2025 a revision to the GDP Guidelines, which completely replaces the version that was issued in March 2013, was published. The November version, which became effective on 24 November 2013, corrects factual mistakes identified in sections 5.5 and 6.3 of the March 2013 Guidelines.
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Improve patient safety and avoid costly product-launch delays
By Kurt L. Moyer and James R. Scull, NSF Health Sciences
Well-documented incidents of contaminants leaching from containers and packaging has brought heightened awareness of the health risks posed by extractables and leachables in...
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In the past two weeks both the FDA and the EMA have made moves to try to respond to growing concern over drug shortages. These measures are:
US FDA
The FDA proposed a new rule that would require drug manufacturers to notify the FDA at least six months in advance of a possible interruption i...
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