Written by Modality Solutions
Posted on: September 5, 2017
Part two of this four part post will focus on the Component/Installation Qualification (CQ/IQ) portion of transport validation. In the previous post I listed processes which must be in place and designed to work together to allow the transport process to be validated. How do those processes come together to allow the transport process to be validated?
Robust test standards and test methods must be in place in your quality management system. These test methods can be either a public standard (e.g. ASTM, ISTA, etc.) or be custom developed. Custom developed thermal profiles are a good example. Best practices require you have a data collection methodology, written protocols, and the data package and conclusions summarized in a report that is reviewed by your quality unit representative. Without these basics in place, your custom developed thermal profile may be question or rejected by the regulatory agencies.
We recommend focuses on component qualification for passive thermal shipping systems and installation qualification for active refrigeration systems. Component qualification focuses on gel ice performance and setting specifications and critical-to-quality attributes for the passive shipper. Examples could include R-value, wall thickness, density, or even weight of the packaging for simpler systems. Whatever these attributes are that impact performance, they must be documented in a component specifications. These specifications should also include allowable tolerances and any substitute components that are available.
Installation qualification focuses on confirming manufacturer specifications were followed during installation of the active refrigeration system and all operating parameters are maintained during load testing. Rather than focus on ‘thermal mapping’ inside a active refrigeration system, a dubious and flawed practice at best, we recommend your IQ focus on component specifications like BTU output, air flow/turn over, and R-value of the walls. This focus on specifications mirrors equipment installation qualification approaches followed in most manufacturing processes more closely than ‘thermal mapping’ of the inside of a trailer.
Both aspects, component qualification (CQ) and installation qualification (IQ) test critical operational controls, focusing on the key attributes for the type of system to be qualified, and supports robust performance during operational qualification (OQ) of the system.
Having test standards, thermal profiles, and verification shipments for transport lane qualification in place allows an organization to have confidence in the qualification of critical components and equipment delivering product safely to patients. In other words it provides for a robust CQ/IQ test. The CQ/IQ ensures that the system and its components are installed correctly and to the original manufacturer specifications.
The qualification deliverables of an organizations product, primary containers, secondary packaging, insulated shippers, and drug delivery devices all require component specifications. The procedures on how to use and assemble them correctly must be documented as well during CQ/IQ. These CQ/IQ report based on test data and procedures are the deliverables at this stage of transport process validation. They define the design space the systems are capable of operating in and the performance tolerances they can be expected to hold during operation qualification (OQ).
Next week we dive into the operational qualification (OQ) of transport process validation. See you then!