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What are IQ, PQ and OQ?
IQ – Installation Qualification
The IQ is the first step in the validation process, ensuring that the machine is correctly installed and meets predefined specifications. This includes verifying installation instructions, electrical connections, safety systems, and other technical specifications.
GTE Engineering ensures detailed documentation (FAT protocol and FDS documentation) for the IQ phase, utilizing the traceability matrix to track where the requirements from the user requirement specification (URS) are covered in the installation and validation documents.
OQ – Operational Qualification
In the OQ, the machine is tested to ensure that it operates correctly within the operational parameters. All functions, such as speed, accuracy, and reliability, are tested. Any deviations are documented and corrected.
During the FAT (Factory Acceptance Test), we assist our clients in performing tests in our workshop, so they can verify if the machine meets the specifications before it is transported to the customer’s location. The results are carefully documented, which is essential for the traceability of the testing process.
PQ – Performance Qualification
The PQ phase involves testing the machine under real-world conditions with actual production materials. This ensures that the machine performs consistently and meets product quality requirements.
At GTE Engineering, we also assist our clients with the SAT (Site Acceptance Test), where the machine is tested and verified at the customer’s site before it is put into production. The results are meticulously documented to demonstrate that the machine operates reliably and meets the specified requirements.
The Importance of Proper Documentation
The Importance of Proper Documentation
Proper documentation of IQ, PQ, and OQ is crucial for achieving GMP compliance and meeting other industry requirements. It offers the following advantages:
- Traceability: Through the traceability matrix, all documents and results can be clearly linked to the requirements in the URS. This allows for quick visibility into where each requirement is addressed in the project.
- Reliability: Detailed documentation ensures that test results are correctly recorded and that no critical steps are overlooked.
- Compliance: Proper documentation is essential for meeting regulatory requirements and is often necessary for audits by agencies such as the FDA or EMA.
The advantage of working with a machine builder knowledgeable in IQ, PQ, and OQ
As a machine builder with extensive experience in the pharmaceutical and medical sectors, GTE Engineering offers significant advantages when it comes to executing IQ, PQ, and OQ. Thanks to our deep knowledge of the processes, we can help clients:
Navigate the validation process more efficiently and quickly
By using a traceability matrix and supporting FAT and SAT protocols, we can optimize the validation process and save time. This accelerates the implementation of the machine into the production environment.
Provide complete documentation
We supply detailed documentation for all stages of the process, including the traceability matrix, which links the requirements in the URS to the tests and results. This ensures full transparency and compliance.
Offer reliability and peace of mind
Thanks to our extensive experience and focus on the pharmaceutical and medical industries, we can guarantee that the machines meet the highest quality and safety standards.
Seamless collaboration
We support clients during the FAT and SAT, ensuring everything runs according to plan, so the machine performs optimally and is ready for use in the production environment.
Conclusion
The validation process of IQ, PQ, and OQ is essential for building machines that meet the strict requirements of the pharmaceutical and medical industries. By working with a machine builder who has expertise in these areas, you benefit from a structured, efficient, and compliant process. We ensure that your machine meets the highest standards and provide thorough documentation to guarantee traceability and compliance.
Looking for a reliable partner for the construction of your pharmaceutical or medical machines? Contact GTE Engineering and discover how we can support you at every stage of the project.
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