How Valuable Are Commercial GDP Certificates?

In the pharmaceutical supply chain, numerous logistical activities are outsourced to external service providers, including specialised transport and logistics companies. These service providers, which are only responsible for the transport of medicinal products, are not directly supervised by the authorities and therefore do not receive an official GDP certificate or wholesale distribution authorisation. Nevertheless, they are obliged to comply with the relevant requirements of the EU GDP Guidelines in order to ensure the quality and safety of the medicinal products they transport.

For logistics service providers, it may still be useful to demonstrate their compliance through external certification. Commercial GDP certificates claim to provide standardised quality assurance, but their relevance and reliability are increasingly being questioned – particularly with regard to the scope, depth and independence of the underlying audits.

Against this background, the ECA organised the webinar Commercial GDP Certificates on 03 November 2025. The speaker, Dr Torsten Schmidt-Bader – Pharmacist, Food Chemist, Specialized Pharmacist for Pharmaceutical Analytics and GMP/GDP Lead Auditor & Trainer  – highlighted key challenges of GDP-compliant logistics and provided the participants with practical recommendations.

The Role of GDP in Pharmaceutical Logistics

The webinar opened with a comprehensive overview of the pharmaceutical supply chain. In view of global supply structures, temperature-sensitive products, and increasingly complex transport routes, logistics providers in the pharmaceutical sector are facing growing requirements. As governmental oversight mechanisms for logistics service providers are often lacking, the responsibility for their qualification rests with pharmaceutical manufacturers – in particular through audits.

Practical Approaches to GDP Compliance

Besides conducting GDP audits, the speaker recommended additional measures such as:

• Quality agreements with logistics service providers;
• Participation in specialised trainings and conferences;
• Efficient monitoring of logistics service providers based on measurable indicators (KPI/QPI).

These approaches can help ensure the long-term quality and reliability of service providers.

Conclusion and Key Messages

The webinar demonstrated that GDP certificates can be a useful tool for ensuring quality in pharmaceutical logistics – though only if chosen carefully and assessed critically. Dr Schmidt-Bader concluded with the following key takeaways:

• GDP certificates have to be reviewed carefully.
• Certificates do not replace an audit.
• Certification organisations are not totally independent.
• GDP compliance checks are more of a fig leaf for authorities or customers than effective suitability evaluations.
• The real performance of a logistics provider (unfortunately) becomes apparent after operations have started.
• Efficient monitoring of supplier performance can be based on a few KPIs/QPIs.
• Increased audit efficiency can be achieved by use of AI applications.

The webinar provided valuable insights and practical approaches for GDP-compliant logistics in the pharmaceutical industry – an area whose importance continues to grow in an increasingly globalised world.