Laboratory quality instrument qualification

Assurance of competent staff begins by preparing position descriptions that specify the educational requirements, operational experience, and duties of the laboratory personnel. The qualifications of the supervisors, analysts, and instrument operators who are hired must match these descriptions. Each staff position should have a set of core training specifications (e.g., radiation safety, chemical safety, waste minimization and disposal, quality assurance) plus specific training in its area of responsibility. Table 13.3 provides suggested position titles, educational requirements, and general responsibilities for the optimal laboratory staff. 

Imagine that you are working with one of the forensic science analytical testing companies and have just undertaken a piece of work at the request of the crown prosecution service. You have analysed a brown powder and found it to contain 70% of the controlled drug diamorphine (heroin). The counsel for the defence has requested that the sample be analysed by an independent laboratory of its choosing. The sample is reanalysed and there is a dispute in relation to the result because the defence analyst finds only 10% of the controlled drug diamorphine. You attend court and are asked to justify your results. Your lab has a rigorous quality assurance system that includes method validation, system suitability, and instrument qualification the defence lab does not. Your result is accepted as the correct value. 

In a GLP-compliant laboratory, a data system must meet explicit requirements guaranteeing the validity, quality, and security of the collected data. Operational qualification (OQ) must be performed after any new devices are installed in the laboratory system and whenever service or repair are performed. The role of OQ is to demonstrate that the instrument functions according to the operational specifications in its current laboratory environment. If environmental conditions are highly variable, OQ should be checked at the extremes in addition to normal ambient conditions. Performance qualification (PQ) must be performed following any new installation and whenever the configuration of the system has been changed. PQ demonstrates that the instrument performs according to the specifications appropriate for its routine use. 

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... 

Qualification activities are normally associated with buildings, facilities, utility systems (e.g., water, air handling, Clean-in-place/Steam-in-place (CIP/SIP), and compressed gases) major equipment (including laboratory instrumentation), whereas validation likely is in reference to those confirmatory tasks related to processes and analytical methods. In simplistic terms, validation (and qualification) can be defined as documented evidence that a process, activity, or piece of equipment can consistently meet its predetermined acceptance criteria and quality attributes. This section will be dedicated towards outlining the requirements for validation of manufacturing processes, as... 

In most quality control (QC) laboratories in this field, there are a number of types of analytical instruments and equipment in practical use. These must be suitable for the intended use in analytical work. Installation qualification (IQ) and operational qualification (OQ) are required before practical use. Calibration of the instruments according to the preset schedule and... 

This chapter discusses aspects of quality assurance of equipment as used in analytical laboratories. It provides guidelines on how to select a vendor and for installation and operational qualifications, ongoing performance control, maintenance, and error detection and handling that contribute to assuring the quality of analytical laboratory data. It refers mainly to an automated chromatography system as an example, but similar principles can be applied to other instrumentation. 

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