A focus on patient safety

The requirements for medicinal products continue after their packaging. As they travel throughout the supply chain, it is crucial to ensure the products’ quality and safety is maintained. Is the medication in the hospital, from the pharmacy, or from the doctor still identical to the one delivered by the manufacturer?

As far as a company is concerned, you can ensure this with the EU Guideline on Good Distribution Practice for Medicinal Products for Human Use. In focus: distribution, safety, cold chain, packaging quality and reliable, functional technology.

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Transparency and reliability in the supply chain

Reduction in damage and losses

Increased legal certainty and reputation

Reduction of customer-specific audits

Beschreibung Standard/Regelwerk

What is GDP - Good Distribution Practice?

The EU Guideline "Good Distribution Practice" is directed at companies in the wholesale and logistics sector that work for the pharmaceutical industry. It specifies the minimum requirements that their services must meet. It also aims to minimize the risks associated with the storage and transport of medicines.

Compliance with the GDP directive ensures control of the distribution chain and thus maintains the quality and integrity of medicines. GDP requires a functioning quality management system according to ISO 9001.This way, companies can supplement the specific requirements of the GDP Guideline with little effort.

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How does a certification according to GDP work?

First, we will discuss your company's requirements and the goals of a certification. Based on these discussions, you will receive an individual quote tailored to your needs.

These steps prepare the actual audit. A project planning meeting is useful for larger projects to plan schedules and conduct audits for individual sites or departments. A gap assessment helps identify strengths and areas for improvement in advance.

In the certification audit, our auditors examine your processes and methods as well as those of your supply chain partners. There is an emphasis on the process steps involving temperature control. For example, technical equipment such as cold storage cells, sensor technology, mapping, and monitoring are considered in addition to process safety, temperature documentation, and emergency concepts. . The auditors will also examine the security of the goods to avoid theft or the exchange of goods. The results are presented in the final meeting and, if necessary, action plans are agreed upon.

After the GDP audit, the results are evaluated by our independent certification board. If all requirements are met, you will receive the certificate.

Annually, key components of the system are re-audited on site for further improvements. The GDP certificate is valid for three years. Before expiration, recertification is performed to ensure continued compliance.


What does GDP certification cost?

Although the GDP audit has specific guidelines and structured specifications, the cost will vary for every organization. Therefore, there is no blanket quote for every company. If you would like to have your company certified, we are happy to calculate a customized quote based on an objective assessment and individual circumstances.


What you can expect from DQS Inc.

  • Auditors with practical experience and a high level of industry expertise
  • Personal, seamless support from our U.S. based specialists with international support
  • Individual quotes with flexible contract terms and no hidden costs
  • Over 80 international offices
  • Global presence, local service
  • Customer and solution-oriented
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Request a quote

Your local contact

We would be happy to provide you with a customized quote for your GDP certification.