GOOD PRACTICE IN THE COLD DRUG SUPPLY CHAIN

Bistra Angelovska, Elena Drakalska Sersemova, Dijana Miceva, Liljana Makraduli , Ilina Trajkova

Abstract

Pharmacy could not function without detailed, efficient, flexible and secure cold distribution chains, so in the future this would mean using more sophisticated delivery techniques and technologies. The cold chain consists of equipment and rules to ensure a constant temperature for thermo-sensitive products from their production to the time of use. Aim: The aim of this study is to evaluate data from WHO, EMA and FDA, their guidelines and directions, as well as relevant data from primary, secondary and tertiary literature. Method: In this paper we will review the regulatory measures and recommendations of the WHO, EU and US regarding the cold chain and will discuss the similarities and differences in their regulation. We summarized the reviewed literary data and sorted them according to the importance of the treated problem, made a comparison of the regulatory measures in order to ensure a safe cold chain and drew appropriate conclusions. Result: The reviewed documents do not show large and substantial differences in the approach to the cold chain and its importance for product safety. Conclusion: Drugs that require storage conditions under controlled temperature must be distributed in a way to ensure that their quality is not diminished.

Pages: 18 - 23