Qualification

Qualification: Identify the essentials.

The term qualification already has its meaning explained in its name: Securing and validating the quality of processes. In GMP-compliant pharmaceutical and food production, plant or equipment qualification is mandatory. We support you in carrying out all necessary tests of your radobio equipment as well as the documentation.

With a device qualification, you prove that your device is installed (IQ) and functions correctly (OQ) in accordance with the GMP guidelines. A special feature is the Performance Qualification (PQ). This performance qualification is part of the validation of the entire production process over a period of time and for a specific product. Customer-specific conditions and processes are checked and documented.

You can read which individual services radobio offers as part of IQ/OQ/PQ in detail in our technology section.

Why is the qualification of your radobio unit important?

The consistent quality of the products we manufacture – not to mention the reproducibility of our test processes – is fundamental to the laboratories and production facilities which operate subject to GMP or GLP requirements. The resulting obligation to provide supporting evidence requires a large number of unit tests to be carried out and recorded precisely. RADOBIO can help you significantly reduce the workload associated with qualifying and validating units.

What do IQ, OQ and PQ mean?

IQ – Installation qualification
IQ, which stands for Installation Qualification, confirms that the unit has been properly installed according to customer requirements including documentation. The technician checks that the unit has been installed correctly, as specified in the qualification folder. The qualification folders can be ordered on a unit-specific basis.

OQ – Functional qualification
OQ, or Operational Qualification, checks and confirms that the unit is operating properly in an unloaded state. The required tests are available in the qualification folder.

PQ – Performance qualification
PQ, which stands for Performance Qualification, checks and documents the unit function in the loaded state under customer-specific requirements. The required tests are defined by mutual agreement according to customer specifications.

What benefits will you get from calibration?

RADOBIO can help you significantly reduce the workload associated with qualifying and validating units.

Reproducible data
Reproducible data for your radobio unit – matched to your processes and standards

RADOBIO expertise
Use of RADOBIO expertise during validation and qualification

qualified and experienced specialists
Implementation by qualified and experienced specialists

 

We are happy to support you with your own IQ/OQ qualifications and in creating test plans for your PQ.

Simply contact us.