Quality Management
Compliance with quality specifications and objectives

Globally applicable KPIs guarantee compliance with defined quality specifications

We ensure that all our production facilities deliver high standards of quality across all products and processes. The Gerresheimer Management System (GMS) makes an important contribution to the achievement of these in-house quality specifications and objectives, and it is mandatory at all of our plants around the world. GMS is a group-wide quality initiative that was rolled out in 2011 to establish uniform quality standards and KPIs in all of our divisions and at all of our production plants. We continuously monitor both production and customer service quality assurance processes to ensure compliance with the quality KPIs. As a result, we can respond significantly faster to any deviations from our target KPIs. Internal monitoring and measurement activities are supplemented by customer feedback and our regular global customer satisfaction survey. We also agree specific quality parameters, in addition to our own quality objectives, with our customers.

State-of-the-art clean room technology and in-house developed quality systems

State-of-the-art clean room technology and quality systems

The extensive use of clean room technology is an important aspect of our commitment to continuous quality improvement. Products are manufactured, processed and packaged in clean room environments at many of our plants. Automated inspection systems are also crucial to product quality. They are widely used at the majority of our plants to measure and inspect every single product and include high-resolution, modern and fully automated camera and sorting systems, as well as quality assurance systems that we designed and developed ourselves, such as Gx® G3, Gx® FLASH, Gx® RHOC, Gx® THOR and Gx® Tekion™.

Support for regulatory processes

We offer our customers our support for any kind of regulatory processes, would it be qualification according to GMP and FDA guidelines and the creation and submission of the documentation for medical products and pharmaceutical primary packaging materials (for example, DMF type III, EU File). Most of our primary packaging materials meet the requirements of the European Pharmacopeia (PH Eur.), the US Pharmacopoeia (USP) and some also the Japanese Pharmacopeia (JP).

Production and process certification for quality assurance purposes

Production and process certification

Certifications serve as objective proof that our production operations and processes fulfill specific criteria and standards. All of our production plants are certified as compliant with the ISO 9001 quality management standard. Numerous plants also have quality management systems for medicinal packaging materials that are compliant with the ISO 15378 standard. Further plants have ISO 13485 certification, confirming their compliance with requirements for a comprehensive quality management system for the design and manufacture of medical devices. Moreover we received the ISO 14001-certified environmental management systems and the ISO 5001 standard for modern energy management systems. Our German Pfreimd plant has an additional manufacturing license for series manufactured secondary packaging and for the production of clinical samples. Regarding the accreditation for stringent application of GMP rules for pharmaceutical packaging to cosmetic packaging we have satisfied the ISO 22716. Besides that it is very important for us to provide a high level of documentation for our products. Therefore we have FDA registrations, Drug Master Files, product registrations and approvals in diverse countries that our customers can use to inform themselves.

Contact
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Gerresheimer
Phone
+49 211 61 81-00