Article: GDP Consideration: Now a Requirement When Shipping IMP

By Ruediger Lomb |

In the past, Good Distribution Practice (GDP) guidelines for shipping Investigational Medicinal Product (IMP) were undefined, meaning the responsibilities of the sponsor for handling and shipping of these products lacked clarity and accountability.

But there is now a much clearer vision for how IMP should be handled, with a 2018 report released by the European Medicines Agency(1) 

Find out more about this vision and the importance of working with a GDP-certified logistics partner to ensure that the updated requirements for shipping IMP are met.

Updated guidelines

These now state that the products remain under the control of the sponsor until after completion of a two-step procedure – the batch certification by the Qualified Person (QP) and the regulatory release by the sponsor. Both steps should be recorded and retained in the clinical trial master file held by, or on behalf of, the sponsor.

The regulatory release should verify that all necessary compliance aspects are in place before IMP is shipped to investigator sites, including contracts, correct clinical trial conditions and de-coding arrangements.

Responsibilities of the manufacturer and sponsor should also be defined in a written contract, including the duties of each party on the handling of deviations during shipment to investigators.

Shipping of IMP

Shipping of IMP should be completed in such a way to minimize any risk while ensuring the quality of the product is maintained with the applicable guidelines on GDP taken into consideration by all accountable parties.

The GDP shipping requirements state that:

  • Shipping is conducted according to instructions given by, or on behalf of, the sponsor
  • Monitoring of the storage conditions is maintained and recorded unless the IMP does not require any special storage conditions
  • All deviations from the specified conditions during shipment are formally investigated
  • A detailed inventory of the shipments is maintained

The control of the IMP shipment remains with the sponsor, until it has been received and accepted by the clinical investigator site. Transfers from one trial site to another should remain the exception and be covered by SOPs.

Why partner with a GDP-certified logistics provider?

Compliance with GDP provisions is important because, as stated by the World Health Organization (WHO), “the quality of pharmaceutical products can be affected by a lack of adequate control over the numerous activities within the distribution process(2).

Having a GDP compliant provider ensures that the appropriate distribution principles are applied to mitigate risk throughout the supply chain, ensuring the best quality product upon arrival to clinical sites.

GDP compliance also means that your chosen providers are constantly reviewing the compliance policies and updating their procedures accordingly, so that your products in transit are in the best possible hands to provide you with the best possible outcomes.

World Courier’s global GDP certification

World Courier is the first logistics company to attain global GDP certification against three major GDP standards – European Union (EU GDP Guidelines), United States Pharmacopeia (USP 1079) and World Health Organization (WHO GDP) – and the only provider to hold a GDP certification with such wide and global scope.

We received the certification in December 2017 following a six–month long evaluation process by DQS, a leading certification body for management systems worldwide. The GDP certification was achieved across the 140+ global office network, and underscores World Courier’s commitment to and compliance with quality management standards and international requirements throughout the supply chain.

Find out more here.

To understand more about World Courier’s GDP certification and the impact our quality standards could have on your supply chain please get in touch.

1 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/05/WC500249275.pdf
2 http://www.who.int/medicines/services/expertcommittees/pharmprep/QAS_068Rev2_GDPdraft.pdf
Topics:
Quality

About the Author

Portrait of Ruediger Lomb

Ruediger Lomb

Vice President, Global Quality and Technical Compliance
AmerisourceBergen Global Commercialization Services & Animal Health
View Bio