Qualification equipment

Equipment Qualification (sometimes referred to as equipment validation) Documented verification that equipment is properly installed, performs as specified throughout operating ranges, and rehably executes desired functions. 

Installation Qualification (IQ) An early phase of equipment quahfication that estabhshes that the instrument is received as designed and specified, that it is properly installed in the selected enviromnent, and that this environment is suitable for the operation of the instrument Nonroutine Maintenance Any repair or instrument maintenance that is not planned or scheduled. 

Operational Qualification (OQ) Following IQ, OQ provides documented verification that the equipment-related system or modular sub-system performs as specified throughout representative or anticipated operating ranges. 

Performance Qualification (PQ) Documented verification that the equipment or integrated system is reliably executing the desired function for which the system was procured. This qualification is to be performed on an ongoing basis by the user. 

Validation Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product or result meeting its pre-determined specifications and quality attributes. 

Equipment qualification applies mainly to safety systems which are required to perform safety functions in accident conditions. 

The conditions under which equipment is expected to perform a safety function may differ from those to which it is normally exposed and its performance may be affected by ageing or service conditions as plant operation goes on. The 

It is preferable that qualification be achieved by the testing of prototypical equipment (type testing). This is not always fully practicable for the vibration of large components or the ageing of equipment. In snch cases extrapolation of equipment performance nnder similar conditions, analyses or tests pins analyses should be relied upon. 

The primary requirement for all equipment (whether it be a volumetric flask, an oven used for drying samples or an atomic absorption spectrometer used for determining trace metal concentrations) is that it must be fit for its intended 

Installation qualification is aimed primarily at new instruments. This is the stage when the checks are carried out to confirm that the instrument received is as specified and correctly installed in the selected environment. This includes both hardware and software. It may be convenient to use a check-list approach to this phase as that ensures everything is checked. This stage covers the installation up to and including its initial response to power, if that is relevant. In addition it may be appropriate to repeat aspects of IQ following relocation or upgrades of instruments. 

Operational qualification establishes that an instrument will function according to its specification in the selected environment. The role of OQ can be considered as demonstrating that an instrument s key operating parameters are within specification and there are no unacceptable differences between the parameters 

It is always recommended that OQ is carried out after a service visit. Evidence of continued satisfactory performance during use (PQ) should be obtained from everyday method-related checks (e.g. system suitability testing, calibration and analytical quality control). It is advisable to set up thresholds outside of which the performance of an instrument is no longer acceptable. Each stage of the equipment qualification needs to be fully documented so that the evidence of performance at any given time can be checked. 

The objective of the review is to determine whether equipment important to safety is qualified to perform its designated safety function throughout its installed service life. 

The review of equipment qualification should determine (a) whether assurance of the required equipment performance capability was initially provided and (b) whether equipment performance has been preserved by ongoing application of measures such as scheduled maintenance, testing and calibration and has been clearly documented. It should be noted that a review relating to (a) above may not be necessary if a previous review has concluded 

It should be ensured that the systems important to safety are capable of performing their safety functions when required in normal operations, external events and anticipated operational conditions, and in and after design basis accident conditions. This is fundamental to preventing the release of radioactive materials and to preventing or mitigating radiological consequences for human health and the environment if it occurs. 

Examples of hazardous enviromnental conditions arising from design basis accident conditions which could cause failure of equipment are the radiological conditions and steam conditions associated with pipe breaks, including breaks of the reactor coolant system. Examples of potentially hazardous process conditions include high velocity two phase flow, high levels of vibration or debris laden process 

Equipment qualification should demonstrate that the equipment is capable of functioning under environmental and operational conditions. The foUowing recommendations, while specific to the design of systems important to safety, shonld be applied in conjunction with other guidance provided on qualification, e.g. Ref. [10]. 

A qualification programme should be completed to confirm that equipment important to safety will be capable of meeting, until the end of its design life, the design basis performance requirements (such as range, accuracy and response) for the assigned safety task, under the environmental conditions (such as temperature, pressure, radiation, humidity or caustic sprays) likely to prevail at the time the equipment will be needed. 

These environmental conditions should include the expected combinations of conditions for normal operation, during anticipated operational occurrences, and during and after design basis accidents. Consideration of severe accident conditions is not required in the equipment qualification programme. However, equipment credited for response to severe accidents should be shown, with reasonable confidence and to the extent possible, to function under anticipated severe accident conditions (Ref. [1], para. 5.46). 

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Sec. 820.70 Production and process controls - Address production procedures and process controls, changes to the process, environmental controls, clothing and hygiene of personnel, prevention of contamination, suitability and layout of buildings, equipment qualification, maintenance, periodic inspection, and adjustment, removal of unwanted manufacturing materials from devices and automated (computer controlled) processes... 

It is important that any method chosen is scientifically sound under the conditions it will be applied. It is also necessary to demonstrate that the equipment, which will be used, is suitable and its use will not influence the results adversely. This includes all types of equipment, e.g. does the volumetric glassware have a suitable tolerance and do the instruments have sufficient sensitivity over the entire range of measurement The process for demonstrating equipment capability is called equipment qualification and is dealt with in Chapter 5. The staff carrying out validation need to be both qualified and competent in the tasks that they need to carry out. 

All equipment has limitations, for example, the amount of a substance it can detect or the accuracy with which it can make a measurement. If you attempt to make the equipment perform beyond its capabilities, it does not matter how carefully the equipment is operated, it will not be possible to get meaningful results. In terms of a particular instrument, fitness for purpose is interpreted as having appropriate performance capability to do the work required. This applies to all equipment, large or small. For example, a stirrer needs to perform the intended task satisfactorily while remaining essentially inert. There is a formal process for assessing the suitability of equipment to perform a given task - this is called Equipment Qualification or Equipment Validation. This is dealt with in Section 5.6.3. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Many of the technical requirements of the Standard are covered in Chapters 4 to 7. The analytical requirements, including choosing a method and method validation, are covered in Chapter 4. The other measurement requirements, such as calibration, traceability and equipment qualification, are dealt with in Chapter 5. Some of the general issues not covered elsewhere are mentioned in the following sections. It has already been mentioned that staff should be trained and proven to be competent to carry out the testing. This applies to permanent and contracted staff. The laboratory should have a job description for all members of staff. There are more stringent requirements on staff who are also able to provide customers with opinions or interpretation of the results. 

Sigvardson KW, Manalo JA, Roller RW, Saless F, Wasserman D. Laboratory equipment qualification. Pharm Technol 2001 October 102-108. 

Burgess C, Jones DG, McDowall RD. Equipment qualification for demonstrating the fitness for purpose of analytical instrumentation. Analyst 1998 123 1879-1886. 

The first edition comprised Val. Section 200 to Val. Section 1300, providing 75 validation SOPs covering design qualification, utilities qualification, facility qualification, equipment qualification, training needs, and major sterile and nonsterile operations-related equipment. 

All the equipment qualification documents must define the equipment designation, tests to be performed, test specifications, materials, operators, reviewers, and responsibility for approval. 

For analytical equipment, qualification is broken down into four areas design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance verification (PV) [2,3]. In this chapter we focus on the operational qualification of a capillary electrophoresis instrument. The tests used in the operational qualification are often used in the routine performance verification as... 

Proper functioning and performance of equipment and computer systems play a major role in obtaining consistency, reliability, and accuracy of analytical data. Therefore, equipment qualification (EQ) and computer system validation (CSV) should be part of any good analytical practice. It is also requested by FDA regulations through the overall requirement that equipment must be suitable for its intended use. While in the past, equipment qualification and computer validation focused on equipment hardware and stand-alone computer systems, recently the focus has been on network infrastructure, networked systems, and on the security, authenticity, and integrity of data acquired and evaluated by computer systems. 

The Laboratory of the Government Chemist (LGC) and Eurachem-UK has developed a guidance document with definitions and step-by-step instructions for equipment qualification [2]. 

Figure 17.1. Equipment qualification phases. (With permission from Ref. [7].)...

Steps for equipment qualification and computer system validation with examples on type and extent of testing... 

Documentation must be complete. On completion of equipment qualification and system validation, documentation should be available that consists of the following ... 

The most important factors for the entire process of equipment qualification and computer system validation in analytical laboratories are proper planning, execution of qualification according to the plan, and documentation of the results. The process should start with the definition of the analytical technique and the development of user requirement and functional specifications. For computer systems, a formal vendor assessment should be made. This can be done through checklists and vendor documentation with internal and/or external references. For very complex systems, it should go through a vendor audit. 

P. Bedson and M. Sargent, The development and application of guidance on equipment qualification of analytical instruments, Accredit. Qual. Assur., 1(6), 265-274, 1996. 

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