spacer
home > pmps > autumn 2003 > temperature-controlled distribution of vaccines and high-value medicine
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Temperature-Controlled Distribution of Vaccines and High-Value Medicine

The cold chain encompasses all the storage and transport facilities necessary to ship a product requiring controlled low temperature storage from the manufacturer to the end user. Most biotechnology and pharmaceutical companies are structured globally and often have a complex supply chain. Pharmaceutical primary substances manufactured in one country are often shipped to a second country with a view to manufacturing bulk medicinal products.

This bulk medicinal product may be filled, labelled and packed in a final container in a third country from which it is shipped to the distributor, who may be situated in a fourth country. From the distributor, the medicinal product is sent to the end user, who may be located in a fifth country. When this complex supply chain must be temperature-controlled, the need for an effective and efficient cold chain becomes apparent. At every point in the cold chain, records have to be maintained to provide evidence of compliance with the labelled storage conditions.

At any given time of year, the distribution environment can vary greatly from country to country and even within the same country. The environment will also change significantly with the season. The International Committee on Harmonisation (ICH) has harmonised the stability testing requirements for medicinal products within three regions, namely Europe, Japan and the USA. Such harmonisation leads to harmonised labelling of storage conditions, which in turn leads to harmonised storage and shipping conditions. The advantage of such harmonisation lies in the fact that stability tests performed in one region are acceptable for the other two regions. Furthermore, medicinal products are treated in a consistent manner.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
By Tanja Leys, Marketing and Quality Manager at Dirk Raes NV

Tanja Leys is an Industrial Engineer at Dirk Raes NV, a transport company in Belgium specialised in temperature-controlled express deliveries across Europe and in the distribution of pharmaceutical products. Her thesis focused on the implementation of ISO-9002 for Dirk Raes NV. After five years' experience in a chemical company as a Reliability Engineer, she became Marketing and Quality Manager, a position she has held for the past four years.

spacer
Tanja Leys
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Vaisala Introduces CAB100 Industrial Cabinet for Cleanrooms

Vaisala, a global leader in weather, environmental, and industrial measurements, launches its newest offering for centralized environmental monitoring in cleanrooms: The CAB100 integrates Vaisala’s world-class instruments for monitoring parameters into a simple, pre-configured enclosure.
More info >>

White Papers

Clinical Trials in Russia Orange Paper: 2nd Quarter 2014

Synergy Research Group

The Ministry of Health of Russian Federation approved 194 new clinical trials of all types including local and bioequivalence studies during the 2nd Quarter of 2014 (3% less than at the same period of the last year). The main contribution to the total number of studies was made by multinational multi-center clinical trials (MMCT) and the number of these studies stayed the same as in Q2 2013 – 81 studies. The number of bioequivalence studies (BE) decreased from 76 studies in Q2 2013 to 59 in Q2 2014, a 22% decrease from last year’s figure. The number of local clinical trials (LCT) increased from 42 in Q2 2013 to 54 clinical trials in Q2 2014.
More info >>

 
Industry Events

DIA 2019 Global Annual Meeting

23-27 June 2019, San Diego Convention Center

DIA 2019 is more than just a meeting: it’s where brilliant minds come together to create solutions. Thousands of global innovators will convene to engage in discussions on today’s hottest topics in the life sciences field, propose ways to combat daily challenges, and network to create lasting connections.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement