Article: GDP Consideration: Now a Requirement When Shipping IMP
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.
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
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.
Article: Safety First
On 5 November 2018, the current EU GDP Guideline turned five years old. What have we learned in those five years? Have we succeeded in achieving a better protection of the integrity of pharmaceutical products and fortified patient safety? What did it mean for the R&D industry, the drug manufacturers and their service partners in the supply chain?
Executive Summary: Logistics by Design - a Framework for Advanced Therapy Developers to Create Optimal Logistics Platforms
Logistics by Design (LbD) is a framework for logistics decision making. Using a risk based analysis it identifies the areas within the supply chain that need to be addressed to create a logistics platform that can meet the needs of patients at clinical and commercial scale.