INSTALLATION QUALIFICATION. (IQ).

The Installation Qualification must verify that the equipment has been installed, activated or put into use, in accordance with the manufacturers requirements, cGMP> rules and regulations, and all health and safety requirements.The regulators go further and place great emphasis on;

The installation qualification should include a review of pertinent maintenance procedures, repair parts lists, and calibration methods for each piece of equipment. The objective is to assure that all repairs can be performed in such a way that will not affect the characteristics of material processed after the repair. In addition, special post-repair cleaning and calibration requirements should be developed to prevent inadvertent manufacture of non-conforming product.

Therefore the IQ must verify that the equipment is registered in a Planned Preventative Maintenance program (PPM), and that the scope of this program is sufficient to ensure that the performance of the equipment will not deteriorate from the performance it delivered during validation.

FDA Compliant and Validation Online have produced interactive installation qualification protocol templates. The design has been arrived at through many years of authoring similar documents for all the major pharmaceutical companies. Each template is prefixed with an SOP which leads you through the document in a proactive manner. A lot of thought and experience went into the design of these documents, making them extremely user friendly and highly cost effective. Protocols such as DQ, IQ, OQ, PQ, along with the associated VMP, URS, VRA, and VP can be prepared electronically, however they are completed by hand and are manually signed and reviewed, and as such are not subject to 21 CFR Part Review.

All our documents have been priced at around the cost of one hour of a protocol author’s time, and I have never heard of an IQ an hour from these guys. With the template downloaded, it is very easy to auto populate the template in minutes and complete the SOP requirements in a further twenty minutes or so, allowing you to produce an IQ in less than an hour, and sometimes even quicker. Where you save, and save big time is when you have a whole array of equipment, it is quite possible (and we have done it) to raise twenty IQ’s in a morning and have them out for peer review and approval by the afternoon.