Have you got it Covered, Week 2
Product Qualification is achieved by subjecting the individual components used to manage temperature sensitive products in a cool chain to two different types of test.
1. Fully controlled static tests (Operational Qualification or ‘OQ’).
2. Dynamic ‘in-use’ tests (Performance Qualification or ‘PQ’).
OQ is conducted under both ‘normal’ and ‘worst-case’ environmental conditions to determine the operational parameters of the individual components and to evaluate how they function as part of an overall cool chain system.
The overall objective is to control the variations that result from the predictable interplay of all the known coolchain elements in order to ensure pharma product quality and patient safety. Both OQ and PQ elements of the Product Qualification feed into an overall Transport Validation which, in turn, will typically form part of a manufacturer’s overall GDP.
The latest EU Good Distribution Practice has extended regulatory measures to cover the CRT temperature band and, at a stroke this has substantially increased the volume of pharma products that are now within regulatory scope.Most pharmaceutical merchandise requires storage and transportation at ambient temperature and a failure to take fully validated thermal protection measures could amount to a catastrophic mistake.
So, the burning question is: “Can YOU vouch for the integrity of the key components being used in your coolchain?”
Click here to view Week 3 – Validation or Qualification