I have a question that’s been nagging me for years…We have equipment that has been installed in our facilities (labs, manufacturing) since time immemorial (say 5 - 20 years ago). Most of these do not have any qualification docs associated with them, but have been installed, maintained and calibrated within each QMS and Maintenance System since installation. All calibrations have been documented and have demonstrated that the equipment operation is acceptable within its operating requirements and that all critical variables meet performance expectations as defined by Pharmacopoeia and Suppliers. How do I address these items from a validation point of view? Do I go back and write IQ/OQ documents retrospectively or do I review the existing documentation to confirm compliance to spec and document this review (against pharmacopoeial expectation, for example)? What happens in the event that I choose to IQ/OQ retrospectively and a particular system fails? Do we then decommission that system and recall all the product ever manufactured/analysed using this system?
My belief is that for established/heritage systems, the documented calibration and maintenance history provides sufficient evidence that the system meets its operational requirements and that critical variables are maintained in a state of control (as per PICS Annex 15, Paragraph 45).
Any opinions on this matter would be highly appreciated. I am trying to refine the approach for assessing equipment. While I am happy with the assessment approach when dealing with new equipment, I’m not convinced that the traditional 4Q approach applies to established systems…