Installation Qualification definition

This chapter defines the terms, responsibilities, requirements and recommended procedures involved in pre-installation, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), which are all part of a typical HPLC system validation process. As the FDA does not publish a definitive reference or cookbook for these procedures, the suggestions herein are only recommendations. These have been successfully incorporated into formal standard operating procedures (SOPs) that have been implemented at a number of larger pharmaceutical establishments. As long as proper SOPs... 

Equipment qualification typically entails installation qualification (IQ), to demonstrate that the equipment is indeed what was specified operational qualification (OQ), to demonstrate that the equipment performs acceptably over its design range and performance qualification (PQ), which demonstrates that the equipment renders consistent performance. No time will be spent providing formal definitions for these terms. 

Definition of Process and Systems Process R D - Installation Qualification Operational Qualification Prospective Performance Qualification i IMb Commercial Production... 

Most firms today start by qualifying each subsystem. To qualify, of course, means to establish convincing evidence that something happens as intended, which matches the validation definition (in more explicit terms, however). Installation qualification may be defined as documented verification that all key aspects of the installation adhere to manufacturer s recommendations, appropriate codes, and approved design intentions. Operational qualification is documented verification that a system or subsystem performs as intended throughout all specified operating ranges. 

Equipment qualification—Definition of the equipment, system, and/or environment used for the process. These data are used to gather a baseline of the installation/operational condition of the system at the time when the performance qualification (PQ) of the system is performed. This baseline information is used to evaluate changes to the system performance over time. Intentional changes from these initial conditions must be considered and evaluated to establish that the system s performance is unaffected by the change. Unintentional changes in the form of a component or equipment malfunction or failure can be easily rectified using the available baseline data as a basis for proper performance. 

As with most pieces of equipment used in a GMP operation, stability chambers must go through a qualification process prior to use. This process traditionally includes three stages identified as the Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). At each stage a qualification protocol is written, approved, and executed. After successful execution a qualification report is written and approved. Upon approval, the next qualification stage is performed. Many components of equipment qualification are common to all pieces of equipment. A brief definition of each stage of qualification will be provided along with what might be included that is unique to stability chambers. 

System qualification is a process that ensures that an analyzer system is installed and operated according to requirements that are aligned with the intended use of the system. The commonly used approach in the pharmaceutical industry is the system life cycle or SLC process. In the SLC approach, the definition of intended use, design, configuration, installation and operation is linked and documented over the lifetime of a system. 

Qualification of equipment and validation of computer systems are not one-time events. They start with the definition of the product or project and setting user requirement specifications and cover the vendor selection process, installation, initial operation, ongoing use, and change control. 

EOQC (1980) European Organization for Quality Control, 4th European Seminar (1980) Validation of Manufacturing Processes (Geneva) [5] Definitions, installation and operational qualification, development and manufacturing phase, responsibilities and organization, use of historical data, change control and revalidation... 

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