Validation performance
GE Healthcare has specially trained and certified engineers who perform IQ/OQ and CCPs in accordance with cGMP.
General information performance
Although the ultimate responsibility for validation lies with the pharmaceutical producer, employing an experienced team from GE Healthcare can expedite your validation effort.
The execution of Installation and Operational Qualification (IQ/OQ) and Change Control Protocols (CCP) requires knowledge of both the techniques involved and the regulatory requirements. GE Healthcare has specially trained and certified engineers who perform IQ/OQ and CCPs in accordance with cGMP.
The on-site performance of IQ/OQ is an excellent opportunity for users and operators of the system to gain information about its technical design and function. We thus recommend that a customer representative closely observe the IQ/OQ work while in progress.
Our trained personnel report directly to the system owner (pharmaceutical producer). Once the system is commissioned and installed, it should function correctly. Complete IQ/OQ work can thus be considered as a verification and control of all documents and functions in the system. The performer reports malfunctions and deviations to the system owner, but does not take corrective measures.
This flowchart illustrates the recommended workflow for IQ/OQ document construction and performance:
Explanation of flowchart keywords
Preparation of IQ/OQ documents. The documentation provided by Fast Trak Validation™ are templates that can be modified to meet in-house validation or IQ/OQ expectations. Each IQ/OQ document is unique for each system and customer, and will accordingly describe the actual system and instrumentation delivered.
Approval of documents. The IQ/OQ documents should be approved by at least two customer representatives (pharmaceutical producer). We recommend that at least one of them comes from the Quality Control/Assurance Dept.
Selection of performer(s). The pharmaceutical producer should authorize the person(s) who will perform the IQ/OQ work. Each section of the IQ/OQ documents has a page for this authorization, which should be signed by the pharmaceutical producer before work is allowed to start. This page acts as the link between the signature, initials and the name of the performer(s).
Performance of IQ/OQ work (report). The tests and verifications as described in the documentation must be performed in accordance with cGMP and all details must be recorded during the IQ/OQ work. All findings and deviations are summarized in a report.
Final IQ/OQ approval. The performer'(s) report is placed in the IQ/OQ binder, and the completed IQ/OQ documents are then approved by the customer. After approval, the next step in the validation can be started: the Process- or Performance Qualification (PQ). All reported deviations must be assessed for the potential impact on the system and process. In some cases, no measures will need to be taken. Other deviations may require correction prior to starting the PQ. The persons to approve the final and completed documents should be the same as those who did the initial approval (see above). | 
