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Clondalkin Pharma & Healthcare, North America becomes first company in US to achieve PS9000:2011 quality certification

Clondalkin Pharma & Healthcare has become the first pharmaceutical printed packaging company to achieve the PS9000:2011 pharmaceutical quality standard certification in North America and across all of their global manufacturing sites.

Jim Franklin, COO at Clondalkin Pharma & Healthcare NA, said, “We operate in a global market place with pharmaceutical products being manufactured in various international centers of excellence.  It is critical to offer our global customers the same high standard of quality across all of our 17 manufacturing locations.”

PS9000 standard applies to pharmaceutical packaging materials and contains the cGMPs intended to assure product quality and patient safety.  The specifics of the standard include everything from contamination control, facility design, cleaning, pest control, line clearance, segregation controls, waste materials, overruns, personal hygiene and security origination processes, to matched plates, print verifications, quarantine and destruction.

Clondalkin Pharma & Healthcare, North America completed a 9-day audit for PS9000-2011 and ISO 9001:2008 certifications with zero (0) non-conformances. This certification will cover all nine (9) Clondalkin Pharma & Healthcare carton, label and literature plants and is in addition to the eight (8) Pharma & Healthcare plants already certified in Europe.

Shannon Walker, VP of Quality at Clondalkin Pharma & Healthcare NA, said, “Achieving this standard in one facility alone is a time consuming, complex and costly process.   Accomplishing quality system harmonization across all of our global manufacturing facilities is a great achievement.  The investment in PS9000:2011 demonstrates our commitment to our customers and the markets we serve”.

Clondalkin Pharma & Healthcare is a market leader in printed packaging components offering multiple solutions for cartons, labels and literature including multi-site product launches, backside printing in-line, digital pre-press, source tagging,  braille, Mirafoil®, tipping literature and labels on or into cartons, Fix-a-Form® booklet labels, Brand Shield® security features and high quality Offset, Flexo and Digital printing from multiple North American sites in Charlotte, NC, Evansville, IN, Greensboro, NC, Guaynabo, PR, Indianapolis, IN, Largo, FL, Manati, PR, Moorestown, NJ and Portland, CT as well as eight (8) manufacturing plants in Europe.

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