Operational Qualification OQ

Operational qualification (OQ) verifies that the instrument actually functions according to its manufacturer s specifications or, more specifically, within limits defined in the user s DQ. Testing procedures and acceptance criteria in OQ are often similar to those in system calibration shown in Table 9.3. In most laboratories, OQ testing is performed by a service specialist from the manufacturer, while subsequent performance qualification (PQ) and calibration are performed by an in-house metrologist or the user. An OQ protocol is often supplied by the manufacturer for a specific equipment model whereas a calibration protocol is a more generic procedure written for different manufacturers models, including older equipment with lower performance. 

Performance qualification (PQ) is the process of demonstrating that an instrument can consistently perform an intended application within some predefined acceptance criteria. In practice, PQ testing is synonymous with system suitability testing conducted with specified columns, mobile phases, and test compounds. PQ is performed during initial system qualification or after the system 

Intended use User requirement specification Analysis of drug products and substances Automated analysis of up to 100 samples/day Limit of quantitation 0.05% Automated confirmation of peak purity and identity with diode-array detection Compatible with 2-mm to 4.6-mm i.d. columns 

Functional specifications Pump Detector Autosampler Column oven Computer Quaternary gradient pump with online degassing and a flow range of 0.01-5 mL/min UV/Vis diode array, 190-600nm with 1-nm resolution 100 sample vials, 0.5-2,000 i.L injection volume 15-60°C, Peltier System control and data acquisition by a computer workstation or a network with remote access 

Operational specifications Pump precision of retention time 0.5% RSD Composition accuracy 1% absolute Detector noise, +2.5 x 10 5 AU Auto sampler precision 0.5% RSD, 0.1 carryover System dwell volume 1 mL Instrumental bandwidth 40 pL (4o) 

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The validation of ne v facilities, systems or equipment is usually accomplished using a four-stage process of design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). 

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. 

Operational performance, primary measurements of, 20 731 Operational qualification (OQ), in fine chemical production, 11 433 Operational systems, for sustainable development, 24 190 Operational testing, piping system,... 

Operational Qualification (OQ) This provides documented verification that the equipment or systems perform as intended throughout the anticipated operating ranges. 

This chapter defines the terms, responsibilities, requirements and recommended procedures involved in pre-installation, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), which are all part of a typical HPLC system validation process. As the FDA does not publish a definitive reference or cookbook for these procedures, the suggestions herein are only recommendations. These have been successfully incorporated into formal standard operating procedures (SOPs) that have been implemented at a number of larger pharmaceutical establishments. As long as proper SOPs... 

As with any data generation or data-handling system, appropriate validation (instrument qualification (IQ)/operational qualification (OQ)/performance qualification (PQ)) is required to demonstrate that the system is accurately and reliably performing in accordance with the user-functional requirements. 

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. 

For the pharmaceutical scientist, understanding the theory and application of the equipment is usually not sufficient there is the matter of compliance. The qualification of CE is similar to that of other instruments. Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) apply in much the same way as high-performance liquid chromatography (HPEC). This chapter details the different parts of the modern CE instrument, equipment-related issues and troubleshooting, instrument qualification, and the future of the CE instrument. 

Operational qualification (OQ) is the process where each component of the system is demonstrated to work properly with the appropriate accuracy and precision. OQ demonstrates that the system works as the manufacturer intended it to work. Example tests for each component of the CE system are listed below. 

Operations checks of the system have been designed in to assure appropriate functioning of hardware and software. The installation qualification (IQ), confirming proper setup of system hardware and software, and the operational qualification (OQ), confirming functionality, have long been included in system valida-... 

The lyophilizers are cleaned using a validated clean-in-place (CIP) cycle using hot WFI. After the cleaning process, a validated sterilization cycle is mn. The qualification of the steam sterilization cycle was performed during the operation qualification (OQ) of the lyophilizer. 

The terms instrument qualification and instrument validation are sometimes used indiscriminately. In this chapter, the term qualification refers to the site preparation and the testing employed to demonstrate that the instrument is properly installed in a suitable environment and the performance meets the predetermined specifications for its intended use. Qualification is a part of the whole validation life cycle. Validation refers to the process to provide assurance that the instrument is suitable for the intended application throughout the lifetime of the instrument. Installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ) are performed to provide evidence that the user requirement specifications (URSs), functional requirement specifications (FRSs), and design qualification (DQs) have been met. The sequence of requirements setting and qualification events as well as the relationships between IQ, OQ, PQ and URS, FRS, and DQ are generally illustrated by the V diagram shown in Figure 2. Installation qualification demonstrates the fulfillment of the DQ. Similarly, OQ demonstrates the fulfillment of the functional requirements and PQ demonstrates the fulfillment of the user requirements. 

Operation Qualification. Operation qualification (OQ) is the process of establishing that the instrument or system modules operate according to the functional requirements in a suitable environment. For an HPLC system, operation of the pump, injector, and detector will be tested at this stage. Typical OQ tests for HPLC modules and a UV-Vis spectrophotometer are as follows ... 

Operation qualification (OQ) is a process used to ensure that the chamber components will operate according to predetermined specifications. OQ tests are... 

Equipment qualification covers the entire life of a product. It starts when somebody has an idea about a product and ends when the equipment is retired. For computer systems validation, this ends when all records on the computer system have been migrated and validated for accuracy and completeness on a new system. Because of the length of time and complexity, the process has been broken down into shorter phases design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) [2]. The process is illustrated in Figure 17.1. 

Once satisfied that the instrument is operating in accordance with its own specification, the end user should ensure that it is fit for purpose for the applications intended. This step is called Operational Qualification, OQ. This process would include writing the Standard Operating Procedure (SOP) and training staff in its use. Further testing may be required to ensure that the instrument performance is in accordance with National and Corporate standards if not carried out in IQ. Frequently, instruments are used with accessories or sub-systems, e.g. sipper systems or other sample presentation devices. Challenge the analytical system with known standards and record what you did. It is necessary to ensure that they work in the way intended and that documented evidence is available to support their use. 

Following completion of the IQ, the equipment or system is subjected to operational qualification (OQ). This is a more rigorous exercise in which the object is to ascertain that the equipment or system being tested performs in accordance with design specifications throughout the full operational range(s). The OQ protocol contains... 

Figure 1 depicts the most commonly used approach to the qualification process as used in the pharmaceutical industry. It shows a pyramid, which is the best way in which to plan a qualification/validation project. Investing more time in the first phases will save time and money in later and critical phases. If inadequate investment is made during the start-up of a project, the later phases of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) will necessarily require an inordinate amount of time and money. The project will be a pyramid again, but now it is inverted. 

Equipment calibration. This quality function for production consists of a viable calibration program for equipment that provides in-process test data or a measurable indication of the controlled process used. This activity is needed so that the manufacturing unit will know whether the equipment is operating consistendy during the time period covered by the calibration activity. This effort is also a continuing commitment of production to maintain its equipment as it was documented to perform during its installation qualification (IQ) and operational qualification (OQ) activities. 

In the following text an attempt is made to give an example of the types of documentation that must be prepared within the validation master plan for the design qualification (DQ), the installation qualification (IQ) and the operational qualification (OQ). Performance qualification (PQ) should follow the successful completion of installation qualification (IQ) and operational qualification (OQ). 

Black box testing is also known as functional testing, benchmark testing and, in the pharmaceutical community, as an operational qualification (OQ). It tests the functionality and correctness of a computer system by running the integrated software, and is performed for one of two reasons defect detection, and/or reliability estimation. It should cover all functions of the application software that the end-user will use, and will verily the completeness and accuracy of system requirements used to define the test cases. 

Equipment qualification has been arbitrarily separated by many practitioners into installation qualification (IQ, focused on system specification, design, and installation characteristics) and operational qualification (OQ, focused on the baseline performance of the system under well-defined conditions). This separation is purely arbitrary in nature, and there is no regulatory requirement that this be the case. For smaller, simpler systems and equipment, consolidation of these activities under the single heading of equipment qualification can save time and expense with no compromise to the integrity of the effort. One of the subtle issues associated with separation of... 

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