ISO 15378:2006 sets out requirements for a quality management system and requires that companies demonstrate the ability to produce drug packaging that meets with regulatory requirements, international safety rules and customer quality standards.
The ISO standard, which was issued by the International Organisation for Standardisation (ISO), also sets out quality guidelines for risk management and validation during packaging production operations.
The facility, which Catalent said is the first in the country to achieve such accreditation, is used to print components for the firm’s drug pack manufacturing operations.
Company general manager Victor Dixon welcomed the accreditation, explaining that the Dublin site will provide a model for “best practice as we roll out the plan to have Catalent’s other Printed Components plants achieve ISO 15378 certification.”
The New Jersey, US headquartered contract manufacturing firm explained that the accreditation process has taken around 12-months to complete with a series of inspections that included a rigours five-day audit 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.”
Catalent went on to say that the management structures, standards and procedures now in place at the Dublin plant have improved standards, enabling it to further improve its service quality.
275 jobs go at Swindon plant
In other news, media reports suggest that Catalent plans to reduce the workforce at its manufacturing plant in Swindon, UK by 275 employees.
The job cuts at the soft gel capsule manufacturing Blagrove facility, which were reported by the BBC news website last week, are due to come into effect by December 2011 and will leave the firm with a workforce of around 550 employees.
Jorge Castro, general manager of Catalent's softgel business, told the BBC that: "We intend to manage this transition to ensure consistent service to our customers, and to effectively support our employees at the site."