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Training, time & planning
The validation of a chromatography process is a complex and difficult task, requiring extensive knowledge in chemistry, microbiology, computer technology and regulatory compliance.
Training
We have specially trained engineers with many years of experience working with GE Healthcares' systems and columns, performing Installation and Operational Qualifications (IQ/OQ) and Change Control Protocols (CCP).
Our certified engineers have performed several hundred IQ/OQs and CCPs worldwide and use calibrated and fully traceable equipment.
Time
Time is an essential factor for validation projects, and it is in everyone's interest to shorten the time for the validation project. Nevertheless, it is essential that all steps in a validation project meet the regulatory requirements to ensure that the system will produce pharmaceuticals with the intended quality.
By offering to perform the IQ/OQ or CCP as a service, we can help shorten the time taken. To perform an IQ/OQ on a large-scale chromatography system (BioProcess™) approximately takes one week, less for an ÄKTA™ system.
Planning
It is essential that the production of the documents, the approval procedure and the performance are well planned. Proper planing will minimize the time needed for the validation process and will ensure that cGMP principles are followed.
For our service engineers to implement the IQ/OQ or CCP, the scope of the work is first discussed with a representative from GE Healthcare. Once the work plan has been agreed upon and an engineer has been authorized to perform the work, we will provide you with checklists to ensure that the work proceeds smoothly and without delays.
Ideally, the planning should be done by a team consisting of representatives from the department delivering the system and the pharmaceutical producer, as well as the service engineer from GE Healthcare who will perform the work. The coordinator is normally the local GE Healthcare sales representative. |
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