Somerset, NJ, November 16, 2009 -- Catalent Pharma Solutions, one of the leading providers of advanced technologies and outsourced services to the global pharmaceutical, biotechnology and consumer health industry, announces the recent achievement of ISO 15378 certification of its Printed Components facility in Dublin, Ireland. Catalent is the first secondary packaging company in Ireland to achieve the ISO 15378 certification standard.
“The ISO 15378 certification achieved by our Dublin site provides our customers with documented assurance of our quality control practices for the safety of our products. We will use the Dublin facility as a best practice as we roll out the plan to have Catalent’s other Printed Components plants achieve ISO 15378 certification, as well,” said Victor Dixon, Vice President and General Manager of Catalent’s Printed Components business. “This is just another step in Catalent’s ongoing commitment to exemplary quality and service for all our facilities.”
Developed with the participation of pharmaceutical experts, ISO 15378:2006 incorporates the quality management requirements of ISO 9001:2000 together with the principles of Good Manufacturing Process (GMP) for the design, manufacture and supply of primary packaging materials for medicinal products. The new standard also gives guidelines for risk management and validation.
The ISO certification project at the Ireland facility took about 12 months to complete, ending with an audit that took place over a five-day period in May. In order for the facility to achieve ISO 15378 certification, the site’s quality manual and standard operating procedures had to be rewritten to be optimized and then implemented. The entire staff had to receive GMP training on the new standards as well as training in product security, traceability and hygiene.
The processes and procedures that are now in place will raise Catalent’s already high printing standards, and increase its product and service quality.
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing, packaging and printing services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at 30 facilities worldwide and in fiscal 2009 generated more than $1.6 billion in annual revenue. For more information, visit www.catalent.com .