Tuesday, December 08, 2020
In recent years, global pharmaceutical supply chains have increased in complexity and scrutinization, due to the involvement of many players with new guidance, regulation and compendial requirements. For example, compliance with the European Good ...
Wednesday, March 11, 2020
Temperature sensitive pharmaceutical products should be transported under temperature-controlled conditions in order to maintain product quality using a Qualified Shipping System (QSS).
Tuesday, September 24, 2019
Temperature is a critical process parameter for many pharmaceutical products as it impacts one of more critical quality attributes like label claim and formation of degradation products. As a result, it must be monitored and controlled in the end-to-...
Sunday, September 24, 2017
With the publication of the European GDP guideline, to better protect the pharmaceutical supply chain all actors in the pharmaceutical supply chain are obliged to perform a full review of all associated Quality Systems.
Critical design parameters of trailer equipment and operational handling procedures in road transportation have a major impact to the airflow and temperature distribution within temperature controlled road vehicles.
Friday, September 30, 2016
Global air freight industry contributes with 0.5% of global world trade in volume but raises at the same time up to 35% of its value or $6.4 trillion according to Air Transport Action Group (ATAG). Managing the transportation of temperature ...
Monday, November 30, 2015
Twenty years ago, the risk to drug substance/product quality due to
temperature excursions during shipping was not generally appreciated.
A series of studies led to several papers in USP PF which documented
some of the risks1-4. In response, ...
How long can a pharmaceutical product be exposed to temperatures
outside the recommended storage conditions? How can product discard
be prevented in cases of temperature excursions? How to establish and
to manage the allowed time out of storage of...
It has been more than one year ago that the new EU GDP Guidelines came into enforced implementation. It is an improvement and a step forward over the previous 1994 Guidance as the new one better reflects the various changes in the distribution ...
Many risk factors impact the products that pass through the Pharmaceutical Supply Chain. While these risks can be adequately mitigated, many are out of the shipper’s direct control. To experience success when distributing temperature-controlled
...