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

Introducing Signant Health [Formerly CRF Bracket] and the Industry’s Most Comprehensive Patient-Centric Suite for Clinical Research

Philadelphia and London – June 10, 2019: CRF Bracket, formed by the 2018 merger of CRF Health and Bracket, today launched as Signant Health (signanthealth.com). Uniting eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite, Signant makes it easier to participate in – and sites and study teams to run – clinical trials. This intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable sponsors and CROs to extend the reach of drug development, expand patient opportunities and improve data quality.
More info >>

White Papers

Planning the Execution of a Viral Clearance Study

Eurofins BioPharma Product Testing

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
More info >>

 
Industry Events

Nordic Life Science Days 10/12 September 2019

10-12 September 2019, Malmo Sweden

Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry. Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends. Nordic Life Science Days attracts leading decision makers from the Life Science sector, not only from biotech, pharma and medtech but also from finances, research, policy and regulatory authorities.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement