Article | September 25, 2015

Risk In Pharmaceutical Packaging

Source: ISPE
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Risk In Pharmaceutical Packaging

Shifting the industry from a compliance culture to a quality culture in pharmaceutical packaging.

In 2010, an examination of 16 FDA consent decrees conducted by Jim Prutow and PRTM researchers (a healthcare consultancy practice) found that one decree had stretched on for 21 years and was still in force, while another had been in force for 17 years and counting. This is not unusual: The majority of pharmaceutical manufacturing consent decrees linger, remaining in force with no official closeout. The cost of these federal decrees to the organizations can run from tens to hundreds of millions of dollars.