Mondi Release Liner in Hilm, Austria, has been certified according the ISO 15378:2006 standard, which combines the principles of Good Manufacturing Practice (GMP) relevant to the design, manufacturing and supply of primary packaging materials for medicinal products with the quality standards of ISO 9001. In addition to the requirements contained in ISO 9001:2000/2008, ISO 15378 contains a list of further specific requirements unique to the primary packaging sector, such as risk management, batch/ lot traceability, validation of critical processes and environmental control.
“Mondi Release Liner takes its responsibility towards its customers, employees and the environment very seriously and that is why we constantly invest in optimization and implementation of recognized standards,” says James Neuling, managing director at Mondi Release Liner.
“Together with our hygiene management certificates, ISO 9001:2008 and FSCTM certificates, the ISO 15378 represents an additional assurance of quality for our customers in the pharmaceutical market”, adds Franz Pehn, managing director at Mondi Release Liner Austria.
The implementation of this standard helps to minimize or eliminate instances of contamination, mix-ups, and manufacturing errors. “This certification is a reliable indicator for our clients that we, as manufacturer of release liners for the packaging industry, constantly act in a responsible and environmentally conscious way," Neuling concludes.