Ensuring Contractors Perform Good Distribution Practices

Q. We understand that as the marketing authorization holder we are accountable for the storage and distribution of our products when we send them to the market. How can we enforce good distribution practice (GDP) with the shipping companies that we contract with?

A. The number of contractors and subcontractors involved in the supply chain for finished goods can be high, and their relationships very complex, particularly when goods are shipped by air or sea. Depending on the scope of the activity (e.g., whether the shipping company is performing transport by land, air, or sea only; whether the company is also a wholesaler; or whether they store the products in their warehouses), and depending on the applicable regulations, these companies may or may not have to comply with GDP regulations. This is probably why you found it difficult to assure that the shipping organizations follow and adhere to GDP.

Transport companies in general are knowledgeable in handling delicate goods, goods that need to be kept at certain temperatures (e.g., foodstuff), and goods of a high value. Thus, many will have a certain level of control for the safe and controlled transport of goods in place. Some companies have already established either pharma-specific transportation services or at least have some experience with transporting pharmaceuticals. These are the companies to look out for in the first place.

Typically, the key issues with regards to GDP concern the maturity of the contractors’ quality systems, their documentation (completeness and trustworthiness), the correct and careful handling, and traceability (knowing where your goods are at any time in the supply chain). The recommended approach is, therefore, for the license holder to negotiate, educate, contract, and then oversee the transportation contractor.

As already mentioned, many of these companies are not required by law to adhere to GDP, so they are unlikely to be aware of the GDP regulations, or how they should implement and adhere to these. Support from the contract giver is called for. Establishing a partnership will provide a win-win situation. This support may include GDP training, support with the upgrade of the contractor’s quality system to include the relevant GDP elements, supplying suitable transport containers, etc.

The relationship must be documented in a quality/technical agreement (1), which should be as granular and detailed as possible, covering all aspects of the outsourced transportation services. For example, rather than merely saying: “the contractor will transport products in table A in temperature controlled vehicles”, this could be detailed as:

• “products in table A will be transported:
• in dedicated (pharmaceuticals only) temperature-controlled vehicles.
• the vehicles are equipped with automatic temperature recording devices.
• the temperature logs are automatically transferred to a printout in the vehicles and transferred electronically to a data center.
• the vehicles are equipped with automatic GPS locators.”

This agreement should also include key performance indicators, such as time to notification in case of deviations (e.g., temperature excursions), the expected frequency of routine audits by the contract giver, and any other oversight activities deemed necessary.

It is through these measures that you should be able to assure your contractors are as compliant as possible with GDP. It may not be an easy and immediate success, but it will certainly be so in the long term.

Reference

1. European Commission. EudraLex Volume 4, Chapter 7, Outsourced Activities. January 2013.

About the author

Siegfried Schmitt is vice president, Technical at Parexel.

Article details

BioPharm International
Vol. 37, No. 3
March 2024
Page: 34

Citation

When referring to this article, please cite it as Schmitt, S. Ensuring Contractors Perform Good Distribution Practices. BioPharm International 2024 37 (3).