Primary packaging materials for medicinical products

The comprehensive quality assurance system of GOLLER Systems is focused to meet the permanently increasing product requirements in the pharmaceutical and medical device industry. Therefore, the company improves the quality of its services continuously.

The Chief Technical Officer, Friedrich Pipelka, confirms: “Certifications in the areas of quality, production and process management are part of the measures we have taken to assure our high quality levels. These certifications are reviewed by internal and external auditors on a regular basis.” (Certifications in accordance with EN ISO 9001:2008, ISO 13485:2003, EN ISO 14644:2001, GMP / FDA guidelines – GMP Directive for 21 CFR 820).

Since October 2011, GOLLER Systems‘ continuous development in the field of Quality Management is reflected by another certification:

Certificate EN ISO 15378:2006

Primary packaging materials for medicinal products
EN ISO 15378:2006

Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)

ISO 15378:2006 specifies requirements for a quality system system where an organization needs to demonstrate its ability to provide primary packaging materials for pharmaceutical products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. ISO 15378:2006 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal/pharmaceutical products.

Certificate EN ISO 15378 (pdf)

Due to the EN ISO 15378 certificate GOLLER Systems is in a position to offer a broader range of products and services to its customers. The existing scope of business is extended by services, such as filling and logistics.

About GOLLER Systems – Hubertus Goller GesmbH

The company based in Klosterneuburg, Lower Austria (on the outskirts of Vienna), has approx. 60 employees and was founded more than 60 years ago by its name sponsor Hubertus Goller. Since then enterprise has remained owner-operated, always combining tradition and vision.

Injection moulding and cleanroom production are the base for the broad range of services offered by GOLLER Systems. Pioneer work such as lip balm sticks or dosage pumps were originated by the company that has specialised in the fields of diagnostics as well as in the pharmaceutical and medical industry since 1990.

The range of products and services comprises the development and production of plastic components and complex systems solutions (incl. the realisation and management of connected processes). The diverse competences of the committed team combine know-how in design and construction, simulation, prototyping, injection moulding and cleanroom production.

An integrated comprehensive quality system system ensures the compliance to all relevant legal requirements and regulations.

GOLLER Systems focus on customer satisfaction, reliability and customised systems solutions: from vision to realisation!

Contact

Mag.(FH) Anna Egger-Piskernik, MBA
Head of Marketing & Sales
Donaustraße 110, A-3400 Klosterneuburg
Tel.+43 (0)2243 / 328 30-75


www.goller.at

GOLLER Systems - from vision to realisation