Analytical 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). 

These components, rigorously interconnected, enable analytical chemists to produce accurate and reproducible data when unknown samples are analysed. Especially the two basal compartments are of crucial importance analytical methods validation and analytical instrument qualification. 

The computer system attached to the instrument provides instrument control, data acquisition, data processing, and reporting. According to the draft Analytical Instrument Qualification chapter of the United States Pharmacopoeia (USP) <1058> The manufacturer should perform design qualification, validate the software and provide users with a summary of the validation. At the user site, holistic qualification that involves the entire instrument and software system is more efficient than modular validation of the software alone. Therefore the user qualifies the instrument control, data acquisition and processing software by qualifying the instrument. ... 

This statement suggests that provided the manufacturer has performed and adequately documented the functions mentioned in the Analytical Instrument Qualification chapter no further qualification activities that are specific to the software is required by the user of the instrument. 

Analytical Instrument Qualification, Pharmacopeial Forum 32(6), November 2006. 

U.S. Pharmacopoeia (USP) (2006), general chapter (1058), Analytical instrument qualification, USP, Rockville, MD. 

Spectroscopic methods can provide fast, non-destructive analytical measurements that can replace conventional analytical methods in many cases. The non-destructive nature of optical measurements makes them very attractive for stability testing. In the future, spectroscopic methods will be increasingly used for pharmaceutical stability analysis. This chapter will focus on quantitative analysis of pharmaceutical products. The second section of the chapter will provide an overview of basic vibrational spectroscopy and modern spectroscopic technology. The third section of this chapter is an introduction to multivariate analysis (MVA) and chemometrics. MVA is essential for the quantitative analysis of NIR and in many cases Raman spectral data. Growth in MVA has been aided by the availability of high quality software and powerful personal computers. Section 11.4 is a review of the qualification of NIR and Raman spectrometers. The criteria for NIR and Raman equipment qualification are described in USP chapters <1119> and < 1120>. The relevant highlights of the new USP chapter on analytical instrument qualification <1058> are also covered. Section 11.5 is a discussion of method validation for quantitative analytical methods based on multivariate statistics. Based on the USP chapter for NIR <1119>, the discussion of method validation for chemometric-based methods is also appropriate for Raman spectroscopy. The criteria for these MVA-based methods are the same as traditional analytical methods accuracy, precision, linearity, specificity, and robustness however, the ways they are described and evaluated can be different. 

Agilent Technologies. 2009. Analytical instrument qualification and system validation (www.home.agilent.com). 

General Chapter 1058 Analytical Instrument Qualification, USP 32 -NF 27, U.S. Pharmacopeial Convention. 2009. 

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... 

As with any analytical instrumentation, processes that involve both operation qualification and performance qualification are implemented during manufacture of the instrumentation for /tPLC described in this chapter to ensure that the instrument will perform according to specifications. 

To ensure that equipment is fit for its intended purpose, there is a series of qualifying steps that the analyst or vendor should apply to analytical instrumentation (3,4). Equipment can be evaluated through a series of tests or procedures designed to determine if the system meets an established set of specifications governing the accepted operating parameters. The successful completion of such tests justifies that the system operates and performs as expected. There are four components of instrument qualification design, installation, operational, and performance. 

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

However the latest thinking provided by the United States Food and Drug Administration (FDA) in the Guidance for Industry for Quality Risk Management suggests that all qualification activities for analytical instruments should be performed using a risk-based approach. 

Similar to method validation, it is important to be able to demonstrate that analytical instrumentation is fit for its intended purpose and that it is calibrated and maintained in an appropriate state of readiness. The verification of instrument qualification (see Chapter 8)... 

Qualification Approaches If an analytical instrument is comprised of different functionally discrete modules, a modular approach to qualification testing that focuses on the specific operations of the individual module can be suitable for certain aspects of some operational testing (such as the flow rate precision and accuracy testing of a HPLC pump and the temperature accuracy column compartment). 

For simple analytical instruments, a simple table to summarize the qualification testing, acceptance criteria, results, and pass/fail decision of the tests will be sufficient since there are fewer tests that are required and the tests are usually relatively simple. For complex analytical systems, a more complex table often referred to as a traceability matrix which traces the requirements, testing, acceptance criteria, test results, and storage locations of the validation documents, test data, and other supporting documents is usually included in the summary report for easy reviewing and quick references. 

The information in this chapter applies specifically to the first element sample preparation. The sample preparation steps are usually the most tedious and labor-intensive part of an analysis. By automating the sample preparation, a significant improvement in efficiency can be achieved. It is important to make sure that (1) suitable instrument qualification has been concluded successfully before initiation of automated sample preparation validation [2], (2) the operational reliability of the automated workstation is acceptable, (3) the analyte measurement procedure has been optimized (e.g., LC run conditions), and (4) appropriate training in use of the instrument has been provided to the operator(s). The equipment used to perform automated sample preparation can be purchased as off-the-shelf units that are precustomized, or it can be built by the laboratory in conjunction with a vendor (custom-designed system). Off-the-shelf workstations for fully automated dissolution testing, automated assay, and content uniformity testing are available from a variety of suppliers, such as Zymark (www.zymark.com) and Sotax (www.sotax.com). These workstations are very well represented in the pharmaceutical industry and are all based on the same functional requirements and basic principles. 

Although industrial laboratories shied away from the technique at first, CE is now becoming more common in these labs for a variety of analyses, including ion analysis, chiral pharmaceutical analysis, and peptide mapping [1]. With the increased prevalence of CE in industrial analytical laboratories comes the need for instrument qualification to ensure the proper functioning and performance of the instrument in order to obtain consistent, reliable, and accurate data. 

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... 

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. 

The Instrumental Criteria Sub-committee of the Analytical Methods Committee has been active for many years in producing Guidelines for the Evaluation of Analytical Instrumentation. Since 1984, they have produced reports on atomic absorption, ICP, X-ray spectrometers, GLC, HPLC, ICP-MS, molecular fluorescence, UV-Vis-NIR, IR and CE. These are excellent source documents to facilitate the equipment qualification process. A current listing of these publications is given in Section 10.2. 

Having chosen the analytical instrument or system, Installation Qualification, IQ, should be carried out to ensure that the equipment works the way the vendor or manufacturer specifies it should. IQ should be performed in accordance with a written test protocol with acceptance criteria with certification from the installation engineer, who is suitably qualified. Full written records of all testing carried out should be maintained as well as ensuring that adequate documentation and manuals have been supplied. The latter should include any Health Safety information from vendor or manufacturer. 

VAM Instrumentation Working Group, Guidance on the Equipment Qualification of Analytical Instruments High Performance Liquid Chromatography (HPLC), 1998. 

The validation of analytical methods is a well-known problem in the analytical community [1], The international guidance for equipment qualification (EQ) of analytical instruments and their validation is in the development stage [2-4], At this time validation of computer systems for analytical instruments is less elaborated [5-7], The term computer system comprises computer hardware, peripherals, and software that includes application programs and operating environments (MS-DOS, MS-Windows and others) [5, 6], Since programs, software and the whole computer system are elements of the instrument used by the analyst according to the analytical method, successful validation of the method as a black box [8] means successful validation of the instrument, computer system, software and programs. On the other hand, the same instrument may also be calibrated and validated as a smaller (in-... 

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... 

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... 

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