Laboratory Equipment Qualification

Laboratory equipment such as incubators, refrigerators, laminar flow hoods, depyrogenation ovens, sterilizers, etc., will be qualified using the same approach as that used for process equipment and utility systems. 

The processes of sterilization and depyrogenation of laboratory equipment and microbiological media will be validated using the same approach as that used for production processes. Test functions and acceptance 

Automatic analyzers will be qualified by performance of Installation and Operation Qualifications. The purpose of the qualification for automatic analyzers is the same as that for any other piece of cGMP equipment to verify that it has been installed and operates in accordance with design specifications, manufacturer recommendations, and cGMPs. 

Perform general operational controls verification testing. 

Operate system throughout the range of operating design specifications or range of intended use. 

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

Laboratory equipment qualification Computer-related systems in QA/QC cGMP procedures and program... 

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. 

Instrument qualifications are the tests that are performed after the equipment is installed for use in a laboratory. Instrument qualifications include installation qualification, operational qualification, and performance qualification. These tests verify that the equipment is installed, operates, and performs according to the manufacturer s specifications. Each of these types of qualifications is defined in more detail in the following sections. 

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]. 

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. 

The transdermal manufacturing process is typically validated after the equipment qualification steps have been successfully completed. A good process validation requires each of the preceding validation steps be done successfully. Given that they are successfully completed, the full-scale process for manufacturing the transdermal is run three consecutive times. All formal SOPs (production, laboratory, warehouse, etc.) that affect the transdermal product must therefore be effective and referenced throughout process-validation activities. 

This effort must extend to the microbiological laboratory as well, in which validation of methods is essential to assure confidence in the results. This will include appropriate testing environments, laboratory sterilization/depyrogenation validation, equipment qualification and calibration, use of standards, and positive and negative controls. 

The Quality Control Unit failed to ensure that adequate procedures were in place to dehne and control computerized production operations, failure investigations, equipment, qualifications, and laboratory operations. [FDA Warning Letter]... 

EQUIPMENT QUALIFICATION AND COMPUTER SYSTEM VALIDATION Office Laboratory... 

Qualified data should be used to calculate the TSU. Data sources may include any of the following operating experience, equipment qualification tests, equipment specifications, engineering analysis, laboratory tests, and engineering drawings. The TSU should account for the effects of process instmment uncertainties, considering the following ... 

Instrument qualification is an important element of laboratory validation. Suppliers s (retrospective) validation plans help with the equipment qualification process. Nowadays the regulatory compliance needs of industry on a global basis are well understood by the instrument vendors. For example, Duncan et al. [118] have illustrated the validation chain for benchtop LC-MS systems and Maxwell et al. [119] have applied the validation timeline to HPLC system validation. Both FDA and USP require that the proper operation of an HPLC system must be validated through a formal calibration program. The components of an HPLC that require calibration include pumps, pump mixing elements, auto-injector, detector, and column heater. 

Quality in NDT depends upon a number of factors. Qualification of NDT personnel, technical state and correctness of choice of testing equipment, availability of approved working procedures of examination, calibration of NDT equipment have decisive importance among those factors of an NDT laboratory. Assessment of NDT laboratory competence is provided through accreditation in compliance with the EN 45000 series standards. 

If the technical staff from the client company recognizes that a toller may be asked to perform new analyses and make operating decisions based upon the results, the client may help the toller develop the needed procedures and skills required to make these decisions. Typically a round robin laboratory qualification exercise will be performed. Samples of known standards and unknown concentrations of the materials to be analyzed for the toll will be prepared and sent to both laboratories. This can help ensure that equipment calibration is synchronized and that the toller is capable of performing accurate measurements. In some cases, the toller may be the party with the chemical, process, or synthesis specific expertise. 

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

Equipment manufacturers are faced with the challenge of qualifying all the functionality of complex equipment at the customer s lab while keeping the costs at a reasonable level. There is an expectation that the cost to qualify laboratory instrumentation be only a small fraction of the cost of the equipment itself. However, there are costs associated with both developing the qualification protocols and executing the qualification protocols. 

It is often the case that laboratories combine the use of equipment from more than one manufacturer into systems that need to be qualified. Each individual device must be qualified for the functionality of that device. Sometimes one manufacturer will sell and qualify other manufacturers devices that connect to their equipment. In this case, one company is responsible for the instrument qualifications of the entire integrated system. It is usually required that each manufacturer qualify its own device, and that following the qualification of the individual devices, the manufacturer that supplies the interface must then qualify the interfaces between the devices. 

The manufacturer often creates an instrument qualification plan and provides installation, operational, and performance qualifications to be executed in the customer s laboratory. The company using the equipment must determine if the manufacturer supplied instrument qualifications is comprehensive enough to be sure that the equipment is installed, operating, and performing correctly. If they feel it is not, they may choose to perform more tests themselves. 

The laboratory shall take into account these factors in developing test and calibration methods and procedures, in the training and qualification of persoimel, and in the selection and calibration of the equipment used. 

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. 

Huber has published two validation reference books for the analytical laboratory [7,8]. The first one covers all validation aspects of an analytical laboratory, including equipment, analytical methods, reference compounds, and personnel qualification. The second covers the validation of computerized and networked systems. 

Drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel. These requirements also apply to selection and control of subcontractors. Subcontractors include toll manufacturers and contract laboratories. 

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