Distribution of Temperature-Sensitive Pharmaceuticals: Requirements according to the EU GDP-Guidelines

Medicinal products are subject to special regulations. It is of key importance that medicinal products are not only made to a high quality in accordance with Good Manufacturing Practice (GMP), but that the quality and integrity of these products are maintained through the entire supply chain to the patient. This is where Good Distribution Practice (GDP) comes into play. GDP is the part of quality assurance that ensures that the quality of medicinal products is maintained at all stages of the supply chain.

Distribution of Temperature-sensitive Pharmaceuticals

Right now, COVID-19 vaccines in particular illustrate the importance of distribution of temperature-sensitive medicinal products - and the challenges involved. For example, how must this vaccine - but also any other temperature-sensitive product in general - be transported to get safely from the production sites to the storage and distribution centres and then on to the local vaccination centres?

EU GDP-Guidelines

In the EU GDP-Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01), special requirements for temperature-sensitive products are mentioned in Chapter 2.4. and Chapter 9.4.:

• Chapter 2.4 (Training): „[…] Personnel dealing with any products which require more stringent handling conditions should receive specific training. Examples of such products include […] temperature-sensitive products.
  A record of all training should be kept, and the effectiveness of training should be periodically assessed and documented.“
• Chapter 9.4. (Products requiring special conditions): „[…] For temperature-sensitive products, qualified equipment (e.g. thermal packaging, temperature-controlled containers or temperature-controlled vehicles) should be used to ensure correct transport conditions are maintained between the manufacturer, wholesale distributor and customer.
  If temperature-controlled vehicles are used, the temperature monitoring equipment used during transport should be main­tained and calibrated at regular intervals. Temperature mapping under representative conditions should be carried out and should take into account seasonal variations.
  If requested, customers should be provided with information to demonstrate that products have complied with the temperature storage conditions. […]
  The process for delivery of sensitive products and control of seasonal temperature variations should be described in a written procedure.“

Implementation

It is the responsibility of senior management in conjunction with the Responsible Person (RP) to ensure that the initial and continuous training of personnel is implemented. The induction training should be captured in a procedure and clearly outline the minimum requirements and tasks which may consequently be performed. It should also include details of the approval process.

If the equipment used is not qualified, the products may be adversely affected during transit. Companies should consider the options available such as temperature-controlled vehicles and active or passive packaging solutions. By having a documented process which accounts for seasonal variations when defining the shipping methods to be used for temperature-sensitive products, the risk of temperature excursions will be minimised.