GDP-compliant Transport of APIs: What needs to be considered?

Medicinal products are subject to special regulations for storage and transport. Good Distribution Practice (GDP) is the part of quality assurance that ensures that the quality of medicinal products is maintained at all stages of the supply chain.

However, GDP is not limited to pharmaceuticals. Rather, GDP starts earlier, namely with the transport of the active pharmaceutical ingredients (APIs) used for production.

Definition of "Transport"

The "Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)" gives the following definition:

• "Transport (transportation): Moving active substances between two locations without storing them for unjustified periods of time."

For APIs for veterinary medicinal products, there is an analogous definition in the "Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council":

• "‘Transport’ means moving active substances used as starting materials in veterinary medicinal products between two locations without storing them for unjustified periods of time."

Requirements for the Transport of APIs for Medicinal Products for Human Use

Requirements for APIs for medicinal products for human use can be found in Chapter 6 of the EU GDP Guidelines. This chapter is divided into "Orders", "Receipt", "Storage", "Delivery to customers" and "Transfer of information". Of particular importance is that active substances should always be transported under the conditions specified by the manufacturer so that their quality is not affected.

In addition, the following applies:

• Supplies within the EU should be made only by registered distributors of active substances to other distributors, manufacturers or to dispensing pharmacies.
• Product, batch and container identity should be maintained at all times.
• All original container labels should remain readable.
• A system should be in place by which the distribution of each batch of active substance can be readily identified to permit its recall.

Requirements for the Transport of APIs for Veterinary Medicinal Products

The requirements for the transport of active substances for veterinary medicinal products are comparable to those for human medicinal products.

In accordance with Article 18 of Implementing Regulation (EU) 2021/1280, the APIs may only be supplied within the Union to other distributors, manufacturers, dispensing pharmacies or to persons permitted by national law.

• Active substances used as starting materials in veterinary medicinal products shall be transported in accordance with the conditions specified by their manufacturer and in a manner that does not adversely affect their quality.
• Product, batch and container identity shall be maintained at all times.
• All original container labels shall remain readable.
• Actions shall be taken to prevent unauthorised access to the APIs being transported.
• A system shall be in place by which the distribution of each batch of active substance used as a starting material in veterinary medicinal products can be readily identified to permit its recall.