A focus on patient safety
As a company 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.
Transparency and reliability in the supply chain
Reduction in damage and losses
Increased legal certainty and reputation
Reduction of customer-specific audits
What is GDP - Good Distribution Practice?
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, for example according to ISO 9001. In this way, companies can supplement the specific requirements of the GDP Guideline with little effort.
How does a certification according to GDP work?
First, we discuss your company's requirements and the goals of a certification together. 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. Emphasis within the process steps is on temperature control. For this purpose, not only technical equipment such as cold storage cells, sensor technology, mapping and monitoring but also process safety, temperature documentation and emergency concepts are considered. In addition, the auditors examine the security of the goods in order 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?
What you can expect from us
- Over 80 international offices
- Global presence, local service
- Customer and solution-oriented