GDP Compliance & Auditing
Compliance services for product storage & distribution.

What is GDP Compliance & Auditing?

Compliance requirements.

Good Distribution Practice (GDP) governs the sourcing, handling, storage, and transportation of medicines for both human and animal use, along with their active ingredients. Authorized wholesalers and distributors must follow GDP guidelines and obtain certification from their National Competent Authority (NCA).

In the European Economic Area (EEA), directives have been in effect since 2001 and with specific guidelines for human products since 2013, and veterinary products since 2021. Their primary compliance goal is the establishment and maintenance of Quality Management Systems that safeguard the quality and identity of medicinal products throughout the entire supply chain.

This not only safeguards end-user patient safety but also shields distributors from potential financial and reputational repercussions.

Auditing overview.

Comprehensive oversight throughout the supply chain necessitates the auditing and effective management of audit programs for all entities engaged in the process, such as retailers, logistics providers, storage facilities, service providers, and packagers.

When conducting Good Distribution Practice (GDP) audits, it is essential to employ appropriate risk-based sampling and testing methods. These methods enable the identification and assessment of specific risks in the area under review, with the audit findings methodically documented in an audit plan.

Click for more information from the European Medicines Agency (EMA) on GDP Compliance.

Supporting your GDP Compliance & Auditing requirements.

Our GDP Compliance & Auditing & Inspections team is thoroughly experienced in the full scope of GDP compliance requirements and the auditing services required to keep your distribution chain safe, compliant, and inspection ready at all times. Our internal and external GDP auditors are experienced and qualified and understand the latest in regional legislation changes and requirements.

Supported by a robust Quality Management System (QMS), we can seamlessly and efficiently adapt to the compliance needs of your distributed products. Our commitment to good communication, reliability, and trust aims to foster a successful and resilient strategic partnership throughout the entire life cycle of your product portfolio.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.