Skip to main content Skip to search Skip to main navigation

What are the phases of a qualification of insulated transport boxes?

Qualifying insulated thermal shipment packaging includes design qualification, in which the fundamental requirements are defined, followed by operational and performance qualification, in which the performance data of the packaging are gathered.

[GMP Compliance Adviser, Chapter 16.O]

Would you like to discover more?

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

EMA: New Q&A on Product Lifecycle Management (PLCM)

EMA: New Q&A on Product Lifecycle Management (PLCM)

The EMA has published new Questions & Answers on the use of the Product Lifecycle Management (PLCM) document, clarifying its role within the EU variations framework for post-approval quality changes.
Read more
EMA: New Q&A for Co-Processed Excipients

EMA: New Q&A for Co-Processed Excipients

The EMA has published new Questions & Answers on co-processed excipients (CoPEs) used in solid oral dosage forms, introducing a harmonised, risk-based regulatory approach applicable to human and veterinary medicines.

Read more
What is the Data Lifecycle?

What is the Data Lifecycle?

Here's the answer:
Read more
Previous
Next