Operational 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. 

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... 

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. 

Prioritization is removed at this stage because the FS represents what will be designed. This definition of the functionality defines the majority of the basis for Operational Qualification (OQ). 

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. 

The words intended ranges in the definition of operational qualification is important. This... 

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. 

Operation, maintenance and calibration procedures Before commencing performance qualification, authorized procedures must be in place for routine use of the facility or operation, training of operators, routine calibration and maintenance, notification and recording of problems, and for the definition of actions to be taken in the event of breakdown. 

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. 

This paper is concerned with the definition and documentation of primary raw data, or in other words, raw data directly associated with a study. Items such as standard operating procedures, methods, personnel qualifications and training records can be considered secondary raw data. Thus, even though these items are also archived, they are not considered explicitly here. But since they are just other examples of paper and/or electronic records, the same archival methods can be used. 

Implementation of the software design commences once the design is finalized. Sandpit (prototyping of application functionality) and development facilities are required to support system definition and development. A validation environment to perform qualification testing and a live environment completes the system development and operational architecture. 

The problem lies in that the specification of the system is not fully known or defined until the CRP is all but complete, and this is typically immediately prior to go live. On a pressured-driven, business-critical project, where is the opportunity to produce an approved System Definition, Installa-tion/Operational/Performance Qualification (IQ/OQ/PQ) test protocols when the information comes so late in the day ... 

The 258 research reactors that no longer operate are in some form of shutdown. Some of these are expected to restart sometime in the future, some are awaiting decommissioning, with or without nuclear fuel in the facility, and the remaining reactors have no clear definition about their future. The undefined status of these remaining research reactors gives rise to safety concerns, in particular in the areas of loss of corporate memory, personnel qualification, maintenance of components and systems, and preparation and maintenance of documentation. 

On the basis of the objectives, functions and responsibilities of the operating organization discussed in Section 3, a proper definition and detailed analysis of tasks and activities to be performed should be made the appropriate staffing and qualification requirements at the different levels in the organization should be determined, and the selection, training and retraining requirements should be specified. 

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