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 an 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 to demonstrate consistency by running three batches. You will need to run your PQ in a normal environment.

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