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IQ is the method for confidently establishing that all major processing, packaging equipment and ancillary systems conform to installation specifications, equipment manuals, schematics and engineering drawings. This phase of validation includes equipment design testing, calibration determination, maintenance and adjustment requirements. For complex or large pieces of equipment, a pharmaceutical manufacturer may elect to conduct a pre-delivery check of the equipment at the supplier’s assembly facility. This pre-delivery check cannot substitute for installation qualification. However, it is recognized that checks conducted and documented at this stage may duplicate several checks conducted at the IQ stage, thus reducing the scope of the IQ check. All equipment, gauges and services should be adequately identified and given a serial number or other reference number. This number should appear in the report of the equipment validation study performed.
Installation qualification requires a formal and systematic check of all installed equipment against equipment supplier specifications and additional criteria identified by the user as part of purchase specifications. These tests, trials and challenges should be repeated a significant number of times to ensure reliable and meaningful results.
At the IQ stage, the company should document preventive maintenance requirements for installed equipment. The preventive maintenance schedule should be included in the routine maintenance schedule.
There will be cases where the equipment was not qualified to be installed at the time of installation and the engineering drawings and manuals for the equipment are no longer available at the manufacturing site; However, the equipment in place has worked for a long time without any problems or changes in its design since it was first installed. In such circumstances, SFDA considers that in this particular case it may be appropriate to verify a limited number of very important parameters that demonstrate that the equipment is adequately installed.
Thereafter, the company may proceed directly to the operational qualification (OQ) stage if there is sufficient documented evidence that these units have always been well maintained and calibrated according to an adequate pre-established schedule.
