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About Us

Assurance of Quality

The Rhenus Quality Management System secures through a complete documentation that all warehousing and quality processes can be carried out in the best possible quality and contributes to continuous improvement. Based on our ISO 9001 Management System we have built up our Quality Assurance System (QA System) for Pharmaceuticals and Medical Devices which enables us to meet the requirements of GMP, GDP, other applicable legislations and ISO standards like ISO 13485.

The QA System determines the warehousing infrastructure of Rhenus, in particular the warehousing temperature, the temperature & humidity monitoring, the storage system, pest control measures, cleaning, access authorization and also all communication processes with customers, suppliers and third parties. All our warehousing processes, working procedures and employee training are set up GMP compliant. To offer best services we can add specific customer needs on top of our standard-SOP in a specific quality agreements.

SOP Management Rhenus

SOP Management

Our SOPs (Standard Operating Procedure) are international, therefore set up multilingual, and are differentiated in Master SOPs, Country SOPs, Local SOPs and Quality Agreements which are defined by you as the customer and are, with its specific customer requirements and storage needs, superior to Rhenus SOPs. It is our aim to combine your QA System with ours to optimize and customize all processes in regards to the specific requirements of your products and distribution markets covered.
Your Quality Agreement with us can describe a variety of topics to ensure that all responsibilities are clarified and all responsible persons are involved and trained on time.

Qualified Personnel
Specific customer needs as well as regulatory requirements call for qualified personnel which involves the responsible person, the head of manufacturing and the head of quality assurance national and international.

To ensure that all Quality Management processes are performed correctly and according to the established standards Rhenus assigned a dedicated Qualified Person. The Qualified Person advises in all pharmaceutical topics and supports the integration of the different approaches of pharmaceutical companies and logistics companies to monitor all Quality Management processes. 

GMP & GDP Compliant

Working GMP & GDP Compliant

GMP & GDP Compliance
Multiple Rhenus sites hold certificates for GMP (Good Manufacturing Practice), GDP (Good distribution practice) and/or EN ISO 13485, but all of our Pharma & Healthcare sites work in the same Quality Assurance System and are checked from independent Quality Assurance officers on a regular basis.

Pharmaceutical Wholesale License
On multiple sites, Rhenus is also holder of the Pharmaceutical Wholesale License. It allows Rhenus to supply pharmaceutical products to pharmacies, wholesalers and sales representatives.

Manufacturing License
Under the Manufacturing License we can also offer you our services in secondary packaging. Our service portfolio covers:

  • Repackage of damaged outer cartons
  • Exchange of package leaflets
  • Relabeling
  • Compilation of product sets

Your Benefits in our manufacturing license:

  • Less costs if repackaging is necessary due to package damage
  • Reduction of transportation costs
  • Less formal expenditure as customer on site
  • Manufacturing rooms on site

Audits & Inspections
Besides having regularly scheduled audits from customers and planned audits from authorities, we also take part in yearly self-inspections to review the Rhenus Quality Management. The Rhenus sites take place in yearly self-inspections that are performed and monitored by independent inspectors.

Change Management

Change Management

Within the Rhenus Pharma & Healthcare sites the applied Change Management System safeguards the maintenance of quality for planned process changes to avoid unapproved changes.

We use a standardized method of documentation, including standard forms and process flows with clear regulations and responsibilities during the change process. All changes are monitored and prioritized based on their impact on the services.

Changes can be implemented in the following areas:

  • Buildings and facilities
  • Safety/security model
  • Temperature management
  • Monitoring systems
  • Pest Control and Hygiene
  • Training
  • Archiving
  • Process management
CAPA System

CAPA System

Rhenus has an integrated electronic Corrective and Preventative Action System (CAPA) on all Rhenus Pharma & Healthcare sites which work based on a plan, do, check and act iterative cycle to achieve a high degree of quality control within the processes. To have an FDA-compliant QM System the ability to capture, review, approve, control, and retrieve closed-loop processes is required.

Supported by thorough documentation, the CAPA system enables the regularly generation of customer reports and internal reports to facilitate mutual learning among all Rhenus Pharma & Healthcare sites within the following areas:

  • Damaged products
  • Customer complaints
  • Cleaning, Hygiene and Pest Control
  • Temperature & humidity
  • Any other process deviations
Validated WMS

Validated WMS

Rhenus has its own self-developed Warehouse Management System (WMS) supported by a comprehensive IT department with developers, 24 hour support and IT-process engineers in our company’s headquarter. The Rhenus WMS has a development, test and production environment covering all stages of warehousing and distribution activities such as inbound, outbound, storage and returns processes.

In our Pharma & Healthcare sites we have the opportunity to use a pre-validated version of our Rhenus WMS to comply with GMP regulations.

The Rhenus WMS has a standard interface which enables Rhenus and the customer to exchange information fast and easily. So far more than 250 interfaces with the Enterprise Resource Planning (ERP) system SAP or Navision have been realized.

CIP Rhenus

CIP

The Continuous Improvement Process (CIP) focuses on various processes in warehousing and transportation ranging from inbound, storage, outbound, returns, use of packing material not only with the goal to achieve cost reductions but also to smooth processes, mitigate disruptions along with shape processes in a more effective and efficient manner.

In general the CIP with our customer projects can be divided into the following stages, whereas the last two stages are repetitive:

  • Initial analysis of customer requests and current setup of customer logistics, followed by suggestions on possible improvements for an implementation at Rhenus site.
  • Implementation & Ramp Up on Rhenus site
  • Stabilization of operations
  • Continuous Improvement of processes
  • Focus on special processes and projects

The main contributors of input for the five stages may vary depending of the nature of the project but usually include the key members of the project on customer side as well as on Rhenus side:

  • WMS Team and project managers
  • Implementation Team
  • Branch Manager
  • Quality Management
  • Staff on Rhenus site

Besides striving for improvements on site Rhenus leverages its knowledge through information sharing within the multiple facilities to keep up with suitable latest technology in regards to 3PL. This is advanced by a central project Management Team consisting of experts in process reengineering, packing and material specialists and an innovation team which is dedicated to automation technology.

Please do not hesitate to contact us if you have any further questions.

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Rhenus Pharma Services GmbH
Berliner Str. 8
16727 Velten
Germany

+49 3304 372 401
pharma@de.rhenus.com