Quality systems instrument qualification

There are four general steps to ensure this control and consequently to guarantee the data quality [32] quality control checks (QC), system suitability tests (SSTs), analytical methods validation (AMV), and analytical instrument qualification (AIQ) (see Figure 5). 

Design qualification should always be performed by the user, whereas installation qualification for large, complex, and high-cost instruments should be performed by the vendor. In some cases, warranty is lost if the user installs the system. Operation qualification can be performed by either the user or the vendor. The decision mainly depends on the available resources at the user s site, and on the vendor s capability to offer such a service with high quality. Performance qualification should always be performed by the user because it is very application-specific and the vendor may not be familiar with the method. As PQ should be performed on a daily basis, this practically limits this task to the user anyway. On completion of equipment qualification, detailed documentation should be available, considering qualification checklist, procedures for testing, qualification test reports with signatures and dates, PQ test procedures, and representative results. 

It is important to provide your customer with reliable results that are fit for purpose. As forensic scientists, we look to do this by performing instrument qualifications (calibrations against verified reference materials) and method validations (using verified reference standards), and by ensuring that we apply rigorous system suitability (see Chapter 7) and quality procedures into our methodologies. In relation to HPLC, qualification relates to an assessment of the instrumentation (pump, injector, column compartment, detector) that is used to determine the measured result, whereas validation relates to the applications and methods that are used to generate the results. 

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. 

As you read on, you will see that choice of the vendor in itself forms part of the assessment process. Instrument qualification forms the basis of any quality programme in relation to the generation of data and there must be documented evidence that the systems are properly maintained and calibrated. For example, it is not good practice—not to mention good use of resources—to spend time validating a method using certified reference materials on an instrument that has never been qualified. This would render the results invalid at best and open to scrutiny in court. 

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. 

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 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... 

After the qualification testing, a summary report should be written to summarize validation activities with a conclusion as to whether the instrument is suitable to be put into routine use. The report should highlight the objective and scope of the validation project, all the qualification test results, test exceptions, and a recommendation for system acceptance. All the test procedures, test results, and the summary report must be reviewed and approved by quality assurance and/or management before product use. 

Installation and operational qualification work includes verification of temperature, pressure, and flow rates, instrument calibration, and thorough flushing of the entire system to remove oil, metal particles, and other contaminants. The type of testing and acceptance limits listed in the validation protocol may vary from firm to firm however, compressed air with product contact should be tested for such quality attributes as hydrocarbons, water vapor, and microbial content (typically less than 0.1 CFU/cu. ft.)... 

Installation qualification is documented verification that the computer system (including all required software) is installed satisfactorily and is compliant with appropriate engineering codes, manufacturer recommendations, and approved specifications, and that the instrumentation is calibrated and all services are available and of adequate quality. 

Continuing the policies of assigning police officer personnel, without physical science qualifications, to the scientific units of police agencies cannot improve the quality of any of the services required of the police. The fact that such policies have been followed by police agencies in this country has inhibited the utilization of the skills and expertise of physical scientists of many specialities and the application of scientific knowledge and instrumentation to the criminal justice system. 

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... 

Vendor qualification is relatively easy if the software or computer system is sold in the same configuration to multiple users. Typical examples are computer systems for analytical instrument control, data acquisition and data evaluation. In this case there is much information available on the quality of the product and on the vendor s behavior in case of problems. This information may be available within the user s firm based on experience of previous versions within the same department or the newly purchased version in other departments. Information can also be gleaned from colleages in other companies. If such information is available, only a little additional information need be collected from the vendor. This can include questions like... 

An interesting and useful classification of steps used to assure quality of analytical data (Bansal 2004) has drawn a clear distinction between quahfication of apparatus used to obtain the data and validation of the methods developed to use the apparatus to obtain the data pertinent to a particular analytical problem. Overlaid on this distinction is another, that between tests that must be completed satisfactorily before acquisition of the desired analytical data can begin (instrument quahfication and method vah-dation) on the one hand, and those that are conducted immediately before or simultaneously with data acquisition (system suitability and quahty control checks) on the other. The original paper (Bansal 2004) represented the outcome of a workshop intended to fiU a need for a more detailed scientific approach to what was termed Analytical Instrument Quahfication (AIQ) , particularly in the context of applications in the pharmaceutical industry. Note in particular that qualification of both hardware and software plays an important role in method validation. 

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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