Quality management Plastic Injection molding
Quality Management

Qualification and validation for international markets

The Gerresheimer business unit Medical Systems uses a globally standardized quality management system that is certified in accordance with ISO 9001, EN ISO 13485, EN ISO 15378 and an environmental management system according to DIN EN ISO 14001. In addition, we comply with the relevant FDA guidelines, GxP and normative product requirements (such as the labeling of medical products). This also means that, in addition to the validated production processes, our buildings and clean rooms as well as the warehousing are qualified and validated in accordance with clearly defined quality criteria. For specific products, we meet additional requirement or standards in our various facilities.

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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

Systematic problem analysis according to the Kepner-Tregoe methodology.
Gerresheimer wins gold for successful application of problem analysis according to the Kepner-Tregoe methodology

Our Quality Management is based on a sound corrective and preventive action (CAPA) system combined with systematic problem solving according to the Kepner Tregoe methodology. A binding change / control process ensures that changes do not have a negative effect on the qualification status of equipment or the validated status of a process.

To handle complaints and deviations, define corrective and preventive actions, and their follow up, we use an electronic workflow management system, i.e. SAP QIM, which fully meets the requirements of 21 CFR part 11. Comprehensive documentation is prepared for all quality assurance measures, which are also included in the respective customer certificates.

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).

Certificate for accreditation as overseas manufacturer

In cooperation with our customers, the Gerresheimer production locations Pfreimd (Germany) 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 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
Mail
Aron Haber
Sales North America
Phone
+1 770 688 5000
Mail
Rafael Kollofrath
Sales South America
Phone
+49 9431 639 6162
Mail
Mike Nie
Sales Asia
Phone
+86 769 8851 7100 317
Mail