Qualification of equipment

Pankaj, Basu, S. and Kumar, A., Seismic qualification of equipment - a need for greater understanding, Proceedings of National Conference on Role of Continuing Engineering Education in Industrial Restructuring, University of Roorkee. February 1995, pp 157-162. 

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. 

Qualification of equipment hardware (e.g., a spectrophotometer or liquid chromatograph). 

Vendor specifications are used as acceptance criteria for operational qualification of equipment. Vendors typically define specifications for analytical equipment instruments such that they can be met easily at the time of installation. However, these specifications are so stringent that problems arise after a period of usage of the instruments, and requalification tests fail. 

As summarized above, the procedure for qualifying equipment begins with a protocol that describes the qualification activity. Qualification of equipment begins with an installation qualification, which is followed by operation qualification and concludes with performance qualification. 

D Equipment Installation and qualification of equipment and cleaning methods... 

Proper functioning and performance of equipment play a major role in obtaining consistency, reliability and accuracy of analytical data. Therefore equipment should be properly selected, designed, installed, and operated, and the correct function and performance should be verified before and during operation. This holds for equipment hardware, computer hardware, hardware interfaces, and software and computer systems. Qualification of equipment hardware is well established and has been described by several authors [1-4], and typically users in analytical laboratories are quite familiar with testing equipment for hardware specifications. 

The attention of any TLC user who is not yet affected by GMP/GLP and who wishes only to complete a small number of good chromatograms in the laboratory should be drawn to an SOP which is entitled Qualification of Equipment for which Qualification is Obligatory and which is relevant to this Chapter [150]. The object of this is to set out the procedure for the qualification of equipment that provides GMP-relevant data. 

Qualification of Equipment The act of planning, carrying out and recording the results of tests on equipment to demonstrate that it will perform as intended. Measuring instruments and systems must be calibrated. 

Two basic approaches to the validation of the process itself exist (apart from the qualification of equipment used in production, the calibration of control and measurement instruments, the evaluation of environmental factors, etc.), namely the experimental approach and the approach based on the of historical data... 

QUALIFICATION (of equipment) The process of determining that a device, apparatus or piece of manufacturing or control equipment meets all design and performance specifications, including boundary , worst case and power failure conditions. This is a necessary preliminary to process validation. 

Procedures shall be in place describing the operations of all critical equipment The qualification of equipment generally includes calibration, installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ). 

Where feasible, equipment should be designed, constructed, and installed to allow for ease of cleaning, and, as applicable, sanitization. Qualification of equipment should ensure that ... 

On the basis of the available prechnical data and on predefined clinical trial plans, ethics committees will evaluate whether the anticipated benefits and risks would justify clinical testing. In addition, local regulatory authorities must be informed and may deny consent. The clinical trial product must be made in compliance with Good Manufacturing Practices with increasing demands (e.g. regarding the qualification of equipment and facihties, product specifications, and validation of methods) as the trials proceed to later phases. 

Qualification of equipment—The qualification of BPC process equipment including reaction vessels, receivers, crystallizers, centrifuges, dryers, filters, distillation columns, solvent distribution systems, etc. is a well-defined activity. While this equipment is somewhat different in design and operating features, than the dosage form equipment that has been the subject of the majority of papers on the subject, the same general principles apply. Reaction vessels, receivers, and crystallizers differ only minimally from formulation and water for injection tanks. Some BPC dryers are identical to those utilized in tablet departments. Solvent distribution systems are piping systems and may resemble WFI distribution systems. Some pieces of equipment such as distillation columns... 

USNRC (1988) Seismic qualification of equipment in operating nuclear power plants . Unresolved Safety Issue A-46, NUREG-1030. 

OMCL Network of the Council of Europe (2013) Qualification of balances. Annex 8 to the OMCL network guideline Qualification of Equipment . PA/PH/OMCL (12) 77 7R... 

As a rule, qualification of equipment and building-related installations takes place before putting into operation (= prospective). Validation of preparation and manufacturing processes is done preferably prospective as well, when designing a new process. However, in some situations qualification or validation has to be performed simultaneously with the application of the equipment or process this is called concurrent qualification or validation. Concurrent qualification or validation should only be applied to simple equipment or processes, where there is very httle chance that the outcome would be negative and products would have to be destroyed. 

It is also possible to perform a qualification of equipment or validation of a production process that is already operational, but has not been previously validated. This so-called retrospective vahdation consists of collecting, evaluating and assessing data from the past. Retrospective vahdation is only possible if no significant changes in the method of preparation or equipment have occurred during the measuring period, and if sufficient, reliable data are available. If that is not the case, additional prospective validations have to be performed. 

GL 2 Qualification of equipment and structures including ageing effects... 

In accordance with NUSS 50-C-D, Section 12, the qualification of equipment important to safety is required to demonstrate their ability to fulfill their intended functions. This qualification requirement applies to normal operating conditions, to accident conditions and to internal and external events. In addition, according to international practice, it should be possible for the plant operators and the regulatory body to examine the associated qualification reports. 

A major concern with respect to WWER nuclear power plants, as shown by safety reviews, is that this practice of qualification of equipment is either lacking or not evident. An example of this is the qualification of electrical and I C equipment, including cable connections, for LOCA conditions. Neither the specifications concerning the test procedures nor the test reports are available at the nuclear power plants. In addition, safety reviews have shown that the cable connections, especially inside the containment of WWER nuclear power plants, are not able to withstand extreme environmental conditions and consequently, they have a high failure potential under LOCA conditions. 

The concern is applicable in particular to old generation NPPs designed to standards which did not call for qualification of equipment especially with regard to accident conditions and ageing. 

This issue was identified from safety reviews and represents a deviation from international practice and especially from NUSS 50-C-D. Insufficient or lacking qualification of equipment important to safety with respect to extreme environmental or seismic conditions would seriously affect defence in depth and the safety functions would be questionable for scenarios within the DB envelope. 

Seismic and environmental qualification of equipment is required in US plants to assure that the equipment will perform its intended functions imder design-basis loading and environmental conditions. For older plants which did not receive adequate qualification when it was designed, the NRC has required that the equipment be reevaluated. 

USNRC Unresolved Safety Issue A-46, Seismic qualification of equipment. 

The steam dump valve to the atmosphere upgrading programme shall be developed, in this case the measures on design changes and changes of control system shall be prepared. The programme shall cover the matters to be clarified as a result of works on qualification of equipment. 

Required documentation demonstrating the qualification of equipment in accident environments is not available or deficient. 

It is UK relevant good practiee that procedures for the qualification of equipment should address operational, environmental and fault conditions specified in the design, and that the... 

Protection from on-site sources (high voltage switch gear and supply cables) could be provided by appropriate shielding of the potential sources and by administrative measures (such as in the case of telephones). Protection from off-site interference should be assessed by means of appropriate qualification of equipment [12]. Special attention should be paid to the installation of qualified equipment in order to fulfil the requirements for emissions and immunity. 

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