EU GDP Management System Certification for Medicinal Products

EU GDP describes the minimum standards that wholesale distributors of items, such as medicines, must meet to ensure that product quality and integrity are maintained throughout the supply chain.

This code of standards aims to ensure that products are distributed to retailers and others without any alteration of their properties. The distributor should also implement a tracing system to enable the finding of faulty products and effective recalling. Furthermore, GDP applies to sourcing, storing and transporting active pharmaceutical ingredients and other ingredients used in producing medicines.

Our management system certification services confirm that your medicinal products comply with EU GDP requirements.

Why choose EU GDP management system certification from SGS?

We can enable you to:

• Demonstrate that your management system complies with EU GDP guidelines
• Show that medicinal product quality is maintained throughout the supply chain, from manufacturing to the pharmacy or supplier
• Confirm that products are always stored in the right conditions, including during transportation
• Avoid contamination by or of other products
• Prevent falsified medicines from entering the supply chain
• Ensure adequate turnover of stored items
• Ensure that the right products reach the right addressee within a satisfactory time

Why SGS?

As the world’s leading testing, inspection and certification company, we are a trusted partner that specializes in quality management system audits and certifications, and offer in-depth expertise in EU GDP requirements.

Certification demonstrates that your management system complies with Guidelines 2013/C 343/01. It is not intended to replace the certificate issued to an inspected entity by a Competent Authority based on Article 111(5) of Directive 2001/83/EC.

We support you through the volume, complexity and breadth of today’s regulatory environment in a globally consistent manner. We also help all stakeholders across healthcare supply chain management and improve product quality in a globally consistent, reliable and efficient way, through services and solutions tailored to the industry.