Qualification installations

Instrumoit qualification is a necessary prerequisite to method develr ment and validation. In essence, if the instrument is not functioning properly, then the results cannot be considered good. Instrument validation includes four steps design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) [80]. These will be presented separately. 

Today most instruments are computer driven. The computer can control any or all of the following instrument operation, data acquisition, data storage/processing, and report generation. As a consequence, software validation is another important aspect of instrument qualification. However, software qualification is currently a much-debated area and is beyond the scope of this presentation. 

Design qualification is performed during the initial assessment of the instrument. It derives directly from the needs of the laboratory. From an assessment of intended method requirements, the minimum specifications of all software and hardware components are generated. These requirements may be either very demanding (e.g., a complex multicomponent multistep gradient separation with very low detection limits) or routine (e.g., a purity assay for a single-substance formulation). 

The laboratory-derived requirements are then compared against system specifications set by manufacturers. If system specifications meet all of the laboratory requirements, then the system meets the design qualification and is considered for use in the analysis. 

Installation qualification consists of a series of unique steps that are taken by both the laboratory and the manufacturer. The laboratory must prepare the bench space and supply adequate ventilation, electrical connections, and computer interfaces (if any). The manufacturer must assemble the instrument in the prescribed fashion and make sure that any options are correctly integrated/installed. After the instrument is 

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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. 

Installation qualification involves performing checks to ensure that the correct equipment or system has been installed and/or connected, including all necessary controls, monitors, instrumentation, or ancillary services. These checks should include verification that relevant operator manuals or instructions have been received from the supplier and that any applicable calibration steps have been identified. 

The validation process is subject to the following design specifications, user and performance requirements, preparation of a master plan/validation protocol (installation qualification, operational qualification, and performance qualification), execution of the protocol, preparation of a summary report, and on-going validation (and revalidation if changes are made). 

Installation qualification (IQ). IQ demonstrates that the equipment/system has been installed correctly at the user site according to vendor standards. The vendor should install the equipment to demonstrate to the buyer that all the components are operating properly. The qualification process includes appropriate documentation of the system components, physical installation and hook-up, and a performance check to verify that the individual components operate and can communicate with each other. System component information, such as serial numbers, type of use, and user performance requirements, should be included in the metrology database for easy tracking and scheduling of maintenance and/or calibration. 

Will vendor perform installation qualification and provide the documentation for this ... 

Validations fall into two types prospective and retrospective. In prospective validation (see flow chart in Figure 2) the validation is done in a sequential manner, involving installation qualification and operational qualification (IQ/OQ) of equipment (e.g., chromatography instrumentation or column hardware). Appropriate calibrations accompany the IQ/OQ. Process qualification, or PQ, involves formal review and approval of a PQ protocol, execution of this protocol, and issuance of a formal PQ report which includes data analysis and recommendations (i.e., approval/certification of the process). If the process is not approved, the report may recommend a redesign or redoing of the validation protocol and, in some cases, a return of the process to process development for further optimization. 

Installation qualification is aimed primarily at new instruments. This is the stage when the checks are carried out to confirm that the instrument received is as specified and correctly installed in the selected environment. This includes both hardware and software. It may be convenient to use a check-list approach to this phase as that ensures everything is checked. This stage covers the installation up to and including its initial response to power, if that is relevant. In addition it may be appropriate to repeat aspects of IQ following relocation or upgrades of instruments. 

Installation qualification Auditing/testing to ensure that specific items of equipment have been correctly installed in accordance with the design specifications laid down... 

In following text an attempt is made to give an example of the types of documentation that must be prepared within the validation master plant for the installation qualification (IQ) and the operational qualification (OP). The examples given are restricted to the process and installation engineering aspects, and exclude the many other aspects, e. g. sterility, biological or chemical requirements, corporate policies or the production environment. The information described are organized in six categories ... 

Installation qualification (IQ), 11 48 in fine chemical production, 11 433 Instant active dry yeast (IADY), 26 461 Instant coffee, 7 257, 260-262... 

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. 

Indeed, the need for capital investment in a CMO may not have been originally anticipated or planned for and may impact on the whole decision making process. Additional costs and time need to be set aside for training and equipment validation, e.g. PQ/IQ/OQ (process qualification/ installation qualification/ operational qualification), and if this includes equipment with radically different operating principles than currently available on site then additional costs will be required for equipment-specific operating personnel and training. 

Installation Qualification (IQ) This provides documented verification that the equipment or systems, as installed or modified, comply with the approved design and that all the manufacturer s recommendations have been duly considered. 

Installation Qualification—The IQ is the protocol that verifies that the installation of the system has followed the guidelines established within the validation plan and is in accordance with the vendor s installation requirements. 

Following pre-installation qualification and the actual installation of an HPLC system, both the IQ and the OQ protocols should be implemented, back to back, soon after the installation. Again, the IQ is used to verify that the installation of the system was successful, with all instrument components powering-up properly. The OQ follows, verifying that the system components perform as they were functionally specified by the vendor. Finally, the PQ protocol serves to verify that the system as a whole performs to the URS established by the user and within the functional limitations of the system as a whole. As part of the PQ, it is recommended to test the system as a whole, called holistic validation. This... 

Automated qualification software is yet another area of CDS development that has been affected by regulatory compliance. When you look at today s CDS solutions, it is typical to see the system providing direct digital control of the instrumentation. Many CDS manufacturers offer software tools that are capable of automating the installation qualification (IQ) and operational qualification (OQ) process. In addition, some manufacturers also offer software that can automate the performance qualification (PQ) for the various forms of instrumentation that it is capable of controlling. These automated software tools are not only time savers for the laboratory, but they also help to properly document the system qualification effort. 

Instrument qualification or validation refers to the process of demonstrating an instrument s suitability for its intended use. The first step is to write protocols to cover the four main qualification elements design qualification, installation qualification, operational qualification, and performance qualification. Another qualification element, re-qualification, can be written as a separate protocol or included as part of the PQ protocol. These protocols must be performed in sequence. If the protocol meets its acceptance criteria, then the next protocol in the sequence can be executed. 

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