"Validera’s strength is the depth and breadth of their capabilities, but also the drive and commitment they have for the work”

Anna Kälvemark, Quality Manager, Pharmadule

Pharmadule builds and delivers production facilities for the pharmaceutical and biotech industries. Validera has been involved in the quality assurance and validation of two such major deliveries – in one case as partial project leader with planning and budgetary responsibility.

“Validera can take on major responsibility for projects and you know that their work will be of high quality,” says Anna Kälvemark, Quality Manager at Pharmadule.

Validera’s assignment concerned a new production facility for packaging fluid-based medicine for the pharmaceutical company Baxter. The facility was delivered to the USA, which meant that production had to meet the FDA’s (Federal Drug Administration’s) strict regulations for quality assurance and traceability.

“Validera’s familiarity with the regulatory framework and validation experience helped to ensure that the facility passed the FDA inspection,” states Anna Kälvemark. She adds that Baxter’s facility in the USA was also named ‘Facility of the Year 2006’ by the International Society for Pharmaceutical Engineering (ISPE), the world’s largest non-profit organization within the pharmaceutical industry. The jury’s motivation was not only that the facility contained innovative technical solutions, but also solutions that supported efficient workflow and good working conditions.

Pharmadule has extensive cooperation with consultants, including when it comes to quality assurance and validation. “Validera are very good! They are highly proficient and work extremely efficiently,” says Anna Kälvemark.

About Pharmadule
Pharmadule is the world-leading supplier of complete modular production facilities for the pharmaceutical and biotech industries. Since 1986 the company has delivered more than 60 facilities to clients around the world, including multinational companies such as Eli Lilly, Merck, Baxter, GlaxoSmithKline, Genentech, AstraZeneca and Pharmacia.

Order values during 2007 were more than 1,400 million Swedish Kronor, divided among four projects in three countries. Pharmadule has its headquarters in Stockholm, Sweden, production facilities in Vara, Sweden and Estland, and offices in the USA, Switzerland and Ireland.