IQ/OQ validation is the formal demonstration that a cryogenic system does what it is supposed to do — under the conditions it will actually be used in. For pharmaceutical companies, biobanks, and clinical facilities operating under GMP or equivalent quality systems, this qualification is not an optional step. It is the foundation of regulatory compliance.
This guide explains what IQ and OQ cover for cryogenic systems, what organizations need to prepare, and how Consarctic® supports this process.
The qualification of laboratory instruments in GMP environments follows a structured approach. The overarching goal is demonstrating that a device is fit for its intended purpose. The process is divided into stages:
IQ — Installation Qualification
Demonstration that the equipment has been correctly installed, according to manufacturer specifications and user requirements.
OQ — Operational Qualification
Demonstration that the equipment functions within its defined operating parameters — under actual operating conditions, not just nominal settings.
PQ — Performance Qualification
Demonstration that the equipment consistently and reproducibly delivers intended performance under production conditions. PQ follows IQ/OQ and relates to actual process performance with actual product.
IQ and OQ are typically performed together as an IQ/OQ package, usually immediately at system commissioning.
An IQ for a cryogenic system — cryogenic tank or controlled rate freezer — typically includes:
The IQ protocol documents a defined acceptance criterion and the actual result for every test point.
OQ tests the function of the system under defined operating conditions:
The OQ protocol documents for every test point:
This documentation becomes part of the device file and must be retained for the entire operational lifetime of the system.
Not every change requires complete re-qualification. But these events typically trigger partial or full re-qualification:
Consarctic® supports re-qualification with the same certified technicians who performed the original qualification — ensuring documentation continuity.
IQ (Installation Qualification) and OQ (Operational Qualification) are qualification stages for laboratory instruments in GMP environments. IQ verifies correct installation. OQ verifies function within specification under operating conditions. Together they demonstrate that a device is suitable for GMP use.
In GMP-regulated environments: yes. For all equipment that directly affects product quality or sample integrity, IQ/OQ qualification is required. This includes cryogenic tanks, controlled rate freezers, and monitoring systems.
A standard IQ/OQ for a cryogenic tank typically requires one to two days on-site, plus subsequent documentation. Similar timelines apply to the BIOFREEZE® controlled rate freezer. The complete qualification report is then available for internal and external audits.
Qualifications can be performed by internally qualified personnel or by certified external service providers such as Consarctic®. As the manufacturer of the cryogenic systems, Consarctic® is the most competent partner for qualification of its own equipment.
Costs depend on system type, number of systems, and site conditions. Consarctic® offers qualification packages with defined scope and predictable costs. Contact us directly for a specific quote.
IQ/OQ qualification requires time and cost. It saves considerably more: inspection findings, production stoppages, recall actions. In GMP-regulated environments, it is the entry requirement for regulatory-clean operations.
Consarctic GmbH performs IQ/OQ qualification through certified technicians — with complete documentation suitable for regulatory use. Serving pharmaceutical companies including Roche, Bayer, and GSK — contact us to discuss your qualification requirements.