Guidelines for Transportation of Pharmaceuticals In Kenya

Pharmaceutical products and starting materials used in the manufacture of pharmaceuticals should be stored and transported under conditions which ensure that their quality is maintained. Transportation should be regarded as an extension of the storage activities and each journey should be treated as unique, with the length and complexity, as well as any seasonal variations being considered when choosing the packing method and mode of transport. There is little point in storing products appropriately if they are compromised by inappropriate transportation

This draft guideline sets out the requirements for transportation of pharmaceuticals to guarantee product quality through the distribution channel from manufacture to consumption/ disposal. The document takes into consideration existing global best practices and attempts have been made to tailor it to the Kenyan scenario. The target audience includes regulators, logisticians and pharmaceutical professionals in industry, government and the international agencies.

• The transport risk assessment should be considered in view of following conditions:
  a. Temperature impact
• b. Humidity
• c. Vibration/ Shock impact
  d. Handling delays during transportation e. Failure of data-loggers
• f. Topping up liquid Nitrogen (inert coverage to product) e.g. Environmental conditions monitoring throughout the transport.

• This document considers reference from the ̳WHO Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products’ and https://www.researchgate.net/publication/308594913_Pharmaceutical_Good_Tr ansportation_Practices_GTP_-An_Innovative_Concept_In_GXP_Acronym[accessed Dec 26 2018]