Clondalkin Pharma & Healthcare claims to be the first pharmaceutical printed packaging company to have achieved the PS9000:2011 pharmaceutical quality standard certification in North America and across all of its global manufacturing sites.
PS 9000:2011 is an application standard developed by The Pharmaceutical Quality Group (PQG) for the manufacture of packaging materials for medicinal products and orally inhaled medicines, defining specific requirements and guidance for Good Manufacturing Practice integrated with the requirements of ISO 9001, ISO 15378 and IPAC RS.
According to Clondalkin, 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 nine-day audit for PS9000-2011 and ISO 9001:2008 certifications with zero non-conformances.
The certification will cover all nine Clondalkin Pharma & Healthcare carton, label and literature plants and is in addition to the eight Pharma & Healthcare plants already certified in Europe, the company says.
Jim Franklin, Clondalkin Pharma & Healthcare NA COO, 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.”
www.clondalkingroup.com
