Quality Management - 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

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

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)

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.

GMS philosophy
Comprehensive evaluation of measurement results with the most modern EDP
The production is shifted upward through continuous improvement. The basis for this is stable processes and improved quality.
The obstacle of "waste" must be corrected through continuous improvement.
Standardization is the wedge that prevents production from falling back into a poorer condition following an improvement.
Leadership and teamwork create the necessary work environment for process and product improvement.
GMS core elements

The foundation of our GMS are employee systems, quality systems, material systems, methods and tools. Use of our GMS ensures that all Gerresheimer employees and partners are integrated into a continuous improvement process. This is necessary in order to sustainably satisfy the needs of our customers and continue to enjoy success in an atmosphere of increasing competition. GMS ensures that we learn from one another and apply best practice throughout the entire Gerresheimer Group. Involved and motivated employees, as well as the use of professional methods and tools, leads to improved and uniform quality throughout the group, which is generated according to the principles of streamlined production. We at Gerresheimer Medical Systems measure the progress of our continuous improvement through regular GMS Performance Evaluations. We formulate detailed analyses of the degree of fulfillment for each location in each of the twenty-nine GMS elements by way of a standardized catalog of questions. Our activity plans for improvements are based on the result of the GMS Performance Evaluation.

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