INSTALLATION QUALIFICATION (IQ).

The Installation Qualification (IQ) execution; verifies that the equipment, and its ancillary systems or sub-systems have been installed in accordance with installation drawings and or specifications. It further details a list of all the the cGMP requirements, that are applicable to the installation. These requirements must all be satisfied before the IQ can be completed and the OQ commenced.

Documented records of qualification and validation, have in the past often not been given sufficient consideration by equipment suppliers and or pharmaceutical companies. As a consequence, companies have not always had sufficient information about the equipment to provided the documented evidence inspectors expected. It is essential, therefore to ensure at the start of any validation project, that the correct information and documentation has been specified and will be available during the validation execution phase.

Our Installation Qualification (IQ) protocol comes with an interactive SOP as an attached prefixed document. As you follow the requirements specified in the SOP, you complete the actual IQ protocol. This makes it a really easy and straight forward document to use. The IQ is normally a stand alone document, however, with careful pre-planning, certain aspects of the IQ activities can be integrated with the Factory Acceptance Testing (FAT), and the equipment Commission Testing. Conformance with continued Good Manufacturing Procedures. (cGMP's) requires, that what ever approach is used, it is fully documented in the individual Validation (Master) Plan (VMP or VP).



The IQ should not start with the Factory Acceptance Testing (FAT) or Commissioning tasks, but it should start before these tasks are completed; enabling the validation team to witness and document the final FAT and commissioning testing. The integration of these activities greatly reduces the costly and time consuming replication of unnecessary retesting.
There is a grey area of testing / inspection in the transition from the IQ to the Operational Qualification (OQ) that is open to rationalization, i.e. it has to be done, but it can satisfactorily be included in either the IQ or OQ. On most projects the simpler the IQ is kept, the quicker it is completed, reviewed and out of the way, allowing progress to the OQ. It can therefore pay dividends to keep the IQ as basic as possible. Where possible, the IQ can be kept to the pre-powering up stage. Keeping the IQ at this level allows healthy project progress. There should be no powering up or utility problems to hinder IQ sign off, and rapid progress through the OQ to the Performance Qualification (P1Q) and where applicable the Process Qualification (P2Q), becomes feasible. It can be reasoned that as soon as you power up, you enter the equipment operation stage, where verification of the User Requirements Specification (URS) and 21 CFR Part 11 verification testing are undertaken.
For this reason we have modulized the IQ and OQ, building in the tests and inspections that are not in this grey area, and building the one's that are, as modules that can be added to either the IQ or the OQ. This has not been done just because it might work, this has been advocated by us for some time. We have experience major delays to projects, caused purely by waiting for the client to complete document reviews and approvals. See Comment 9 in cGMP-FDA-483-inspection.