Design Qualification

The DQ describes the document used to report a review of a design conducted by qualified people.

Installation Qualification

The IQ protocol verifies that peripheral devices are installed in accordance with installation plans and/ or specifications. Furthermore, it includes a detailed list of cGMP requirements applicable to this installation. These requirements must be met before the IQ can be completed and one can proceed with the Operational Qualification (OQ).

Operational Qualification

The OQ document describes how a machine or installation functions normally. It is also called SOP’s (Standard Operating Procedure). In this qualification, all procedures for start-up, operation, maintenance, safety and cleaning / disinfection are described.

Performance Qualification

This document describes all procedures used to verify the capabilities defined in the URS (User Requirement Specification). cGMP issues are also qualified in this document.


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