IQ, OQ, PQ

IOPQ Template

This is a combination of the IQ, OQ and PQ. You can use this for a full qualification, add or remove any sections as you require. The combined qualification has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment. The IQ section establishes all requirements for Installation, once you have documented all your requirements for IQ, you should progress to OQ to establish the limits. You may need to support this with a Design of Experiments (please contact us for further information on how to establish your parameters) you will need to test all limits to find the outer ranges of your process/equipment. Once you have demonstrated a successful OQ you may progress to the PQ, upon which the template will guide you demonstrate consistency by running three batches. You will need to run your PQ in a normal environment.

A 5-page preview of the Installation, Operational and Performance Validation Protocol is available here:



You may purchase the full 35 page document in convenient Microsoft Word format including instructions for use below.

Price - £80 per download*





Note: Once payment is complete - click on the "return to merchant" link to instantly download your purchase.


IQ Template

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.

A 4-page preview of the Installation Qualification Validation Protocol is available here:

You may purchase the full 17 page document in convenient Microsoft Word format for use below.

Price - £20 per download*



Note: Once payment is complete - click on the "return to merchant" link to instantly download your purchase.


IOQ Template

This is a combination of the IQ and OQ, add or remove any sections as you require. The combined qualification has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment. The IQ section establishes all requirements for Installation, once you have documented all your requirements for IQ, you should progress to OQ to establish the limits. You may need to support this with a Design of Experiments (please contact us for further information on how to establish your parameters) you will need to test all limits to find the outer ranges of your process/equipment. You can use this template where you feel there is no need to perform a PQ. (if you are doubtful please contact a consultant)

A 7-page preview of the Installation, Operational Validation Protocol is available here:

You may purchase the full 26 page document in convenient Microsoft Word format for use below.

Price - £60 per download*



Note: Once payment is complete - click on the "return to merchant" link to instantly download your purchase.

OPQ Template

This is a combination of the OQ and PQ, add or remove any sections as you require. The combined qualification has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment. You may be in apposition where equipment has been installed for several years and find no benefit of performing an IQ which may be supported with a rationale. You should use the OQ to establish the limits. You may need to support this with a Design of Experiments (please contact us for further information on how to establish your parameters) you will need to test all limits to find the outer ranges of your process/equipment. Once you have demonstrated a successful OQ you may progress to the PQ, upon which the template will guide you demonstrate consistency by running three batches. You will need to run your PQ in a normal environment.

A 6-page preview of the Operational & Performance Validation Protocol is available here:

You may purchase the full 19 page document in convenient Microsoft Word format for use below.

Price - £40 per download*



Note: Once payment is complete - click on the "return to merchant" link to instantly download your purchase.

OQ Template

If you have installed any system, component, equipment you will need to perform an installation qualification. However if you have an adequate IQ then you can progress to OQ and use this template.

You should use the OQ to establish the limits. You may need to support this with a Design of Experiments (please contact us for further information on how to establish your parameters) you will need to test all limits to find the outer ranges of your process/equipment.

A 4-page preview of the Operational Qualification Validation Protocol is available here:

You may purchase the full 15 page document in convenient Microsoft Word format for use below.

Price - £30 per download*



Note: Once payment is complete - click on the "return to merchant" link to instantly download your purchase.

PQ Template

If you have installed equipment that has successfully established its limits and there is no need to test these then you can progress to PQ, upon which the template will guide you demonstrate consistency by running three batches. You will need to run your PQ in a normal environment.

A 3-page preview of the Performance Qualification Validation Protocol is available here:

You may purchase the full 12 page document in convenient Microsoft Word format for use below.

Price - £20 per download*



Note: Once payment is complete - click on the "return to merchant" link to instantly download your purchase.




*All prices quoted include a 500 word limit of email support.