If you have installed any system, component, equipment you will need to perform an installation qualification.
The (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 cGMP requirements that are applicable to this particular installation qualification. These requirements must all be satisfied before the IQ can be completed and the qualification process is allowed to progress to the execution of the Operational Qualification (OQ).
In the past equipment suppliers have often been delinquent in supplying the right scope and quality of support documentation for their products. As a consequence end user companies have not always had sufficient information (especially in the form of engineering drawings and specifications) about the equipment they have purchased, to develop and put into place the quality of documentation that regulatory requirements demand. For correct and trouble free qualification it is really essential that the scope and quality of the proposed equipment documentation; is specified at the equipment procurement stage.
Our IQ protocol has been designed using guidelines from the FDA and MHRA to satisfy requirements from both regulatory bodies, however if you would like an SOP supplied please contact us or download this in the appropriate section in this website. The IQ should begin once the FAT has been completed, if you require a FAT download in the template section. Depending on the size of your project you will need to supply the appropriate evidence appended and signed/verified complete to GMP requirements. Our protocol is available in MS Word completely editable to your requirements.
*All prices quoted include a 500 word limit of email support.