Quality management Plastic Injection molding
Quality Management

Qualification and validation for international markets

The Gerresheimer Medical Systems business unit works with a globally uniform quality management system that is certified according to ISO 9001EN ISO 13485 and ISO 14001. In addition to this, we work in accordance with the relevant FDA guidelines, GxP and normative product requirements. Thus, in addition to the production processes, we also qualify and validate buildings and clean rooms, as well as storage according to clearly defined quality criteria. We fulfill additional requirements or standards product-specifically at various locations. We thus possess, for example, a manufacturing license for the secondary packaging of pharmaceutical products according to the German Drugs Law (AMG).

Your PLUS with Gerresheimer

Validation along the entire value creation chain

Clean room production inhaler, injection molding, assembly and testing
Torque testing of an inhaler in a highly automated assembly system

Our validation approach follows the classic V model and encompasses all phases of DQ up to PQ. Each individual production process is validated in order to ensure that the total of all steps leads to the desired, process-secure production sequence. During the product origin process, the tests defined in test planning and verified during validation extending from incoming goods through process tests to approval testing are carried out by our quality planning in the Technical Competence Center in cooperation with Production. Our Quality Planning has its own quality lab in which extensive tests in the areas of material, geometry and function are carried out during all phases of the product origin process. It contains a measuring room with product-specific testing equipment for the geometric measurement of components, assembly units and finished products, a lab for material analyses and a lab for functional tests. If necessary, corresponding product tests are integrated into our highly automated assembly systems in order to ensure you the highest degree of product safety.

Systematic error processing

Visual inspection of an inhaler component
Visual inspection of an inhaler component

Our Quality Management has installed systems for corrective and preventive error processing (CAPA). Our processes are also revalidated regularly. An obligatory change-control procedure ensures that the validated state of a process is not negatively influenced by changes.

We use an electronic work flow management system, i.e. SAP QIM for the processing of complaints, the definition of corrective and preventive actions and the tracing of the same. This completely satisfies the requirements of 21 CFR Part 11.

Comprehensive documentation about all quality assurance measures is maintained, which also flows into the corresponding certificates of our customers.

FDA inspection

FDA inspection for a medical product
Successfully FDA-inspected: the production of the CentriMag® blood pump system

A successful inspection by the FDA has confirmed that the Medical Systems business unit of the Gerresheimer Group occupies one of the top international positions in the production of medical technology in terms of performance and quality. The audit covers the entire value creation chain of production in our facilities.

Participation in the registration of product files

Medical product CE mark
Gerresheimer has assumed the CE mark for a sterile wound adhesive set

We assume responsibility for both the 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).

Manufacturing license according to German drug law (AMG)

Manufacturing license according to German Drug Law (AMG)

Gerresheimer Regensburg GmbH possesses a manufacturing license in accordance with the German Drug Law (AMG) for secondary packaging in series production and for the production of clinical test samples.

Certificate for accreditation as overseas manufacturer

In cooperation with our customers, the Gerresheimer production locations Pfreimd (Germany), Horšovský Týn (Czech Republic) and Dongguan City (China) have been accredited as manufacturers for medical products. The certificates for accreditation as "Overseas Manufacturer" in Japan are valid for five years.

Accreditation as Overseas Manufacturer for production location China
Accreditation as Overseas Manufacturer for production location Czech Republic
Accreditation as Overseas Manufacturer for production location Germany

Gerresheimer Management System (GMS)

Gerresheimer Management Systems
Continuous improvement through GMS

We want to become better all the time, for our customers and for human health. Our key for this is GMS: Gerresheimer Management System.

In the Gerresheimer Group, the Gerresheimer Management System (GMS) provides the foundation for the continuous improvement of all business processes. GMS contains and describes the most important methods, processes and rules of a facility in a systematic and standardized form, and thus creates transparent, binding standards. Our criteria for success in terms of customer satisfaction are the goals of the GMS: Products and services of the highest quality, minimal costs, observance of delivery times, product and process innovation, correction of waste, continuous improvement, recruitment, development and retention of competence and consistent integration of all employees.

Contact
Contact us!
Alexander Schiessl
Sales Europe
Phone
+49 9431 639 6292
Shane Anderson
Sales North America
Phone
+1 609 369 1679
Rafael Kollofrath
Sales South America
Phone
+49 9431 639 6162
Mike Nie
Sales Asia
Phone
+86 769 8851 7100 317