Quality Management
Compliance with quality specifications and objectives

Mandatory quality specifications using global performance indicators

We maintain a high level of quality across our products and processes and at all our production sites as a matter of course. It is largely thanks to the Gerresheimer Management System (GMS) – which is in force at all of our plants around the world – that we are able to meet our self-imposed quality specifications and objectives. The group-wide quality initiative was introduced in 2011 and has developed obligatory quality specifications and performance indicators across all of the Business Units, which have been implemented in all of our plants around the world. Using these performance indicators, we continuously monitor processes to guarantee the level of quality in production, processes, and our customer service. This significantly reduces our response times in the event of deviations from our self-imposed objectives. As well as monitoring and measuring internal performance indicators, we seek feedback directly from our customers. As well as our own quality objectives, we also devise other customer-specific quality agreements.

Gerresheimer continued the “Quality in Everything” global quality campaign for all employees through 2018 and 2019. Launched in 2017, the campaign aims to increase each employee’s awareness of their personal responsibility for quality in its many facets. The quality campaign has been rolled out in all plants via a range of communications measures, including newsletters, posters, flyers, videos and an activity day.

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

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

A key part of our ongoing efforts to improve quality is our increased use of clean room technology, which we are continuously expanding and improving. Products are manufactured, processed, and packaged in clean rooms at many of our plants. Automatic inspection of our products also forms a crucial element. Automatic inspection systems are widely used in the vast majority of our plants to measure and inspect each individual product, a process in which high-resolution, modern, and fully automated camera and sorting systems play a pivotal role. We also use our own quality systems developed in house, including the Gx® G3, Gx® FLASH, Gx® RHOC, Gx® THOR, and Gx® Tekion™.

Support with regulatory processes

We are happy to help our customers with regulatory processes, including qualification in accordance with GMP and FDA guidelines and preparing and submitting documentation for medical products and pharmaceutical primary packaging (e.g. Drug Master Files DMF type III and EU files). Most of our primary packaging products meet the requirements of the European Pharmacopeia (Ph. Eur.), the US Pharmacopeia (USP), and in some cases the Japanese Pharmacopeia (JP) as well.

Guaranteed quality thanks to certified production and processes

Guaranteed quality thanks to certified production and processes

Initial and regularly renewed certification serves as objective proof that our production operations and processes conform to specific criteria and standards. All our production sites are certified to ISO standard 9001 in terms of their quality management systems. 20 out of our 38 production sites meet ISO standard 15378 as regards special requirements that apply to manufacturing pharmaceutical primary packaging.12 are certified in accordance with ISO standard 13485, which describes requirements for a comprehensive management system regarding the design and manufacture of medical products. In addition 13 are also certified to ISO 14001 for our environmental management and 12 out of 46 sites received the ISO 50001 for our modern energy management system. Our Pfreimd site in Germany is also authorized in accordance with the German Medicinal Products Act to mass-produce secondary packaging and to produce clinical test samples. As regards transferring the complex GMP regulations from pharmacy over to cosmetics packaging, we meet ISO 22716. Furthermore, it is very important to us to supply a high level of documentation for our products. That’s why we have FDA registrations, Drug Master Files, and product registrations and licenses in numerous countries, which allow customers to find out everything they need to know about our products.

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Gerresheimer
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+49 211 61 81-00
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