Installation Qualification testing

Document Number IQOO-00001 Install Qualification Test Version 1.0... 

Typical Installation Qualification test functions include, but are not limited to, the following ... 

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

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. 

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... 

The system consists of an oil-free compressor, drier, storage tank, and distribution system. The validation process consists of installation qualification, operational qualifications, and actual validation testing of the operational system. 

The installation qualification of automatic control systems shall consist of a logical panoply of tests. The tests are carried out step-by-step on each component. The structure of the installation qualihcation shall be standardized for all installation qualihcations of computerized pharmaceutical systems as follows. 

List of operation parameters (cycle events/times, TC distribution probes, biological indicator test, installation qualification review, sterilizer SOP review) acceptable limits, and study results... 

When new equipment is purchased or there is a change in the manufacturing site, qualification exercises are performed as part of the validation process. Qualification (installation qualification, operation qualification, and performance qualification) for any equipment or facility is an extreme process which involves testing, verification, and documentation to assure that the particular equipment or facility is per the specification and meets the appropriate standards as defined by vendor and required by manufacturing and engineering personnel [14]. 

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. 

During system installation and qualification testing, use screen capture to print the information for evidence whenever possible as it is a more efficient and complete way to document the results and observations than writing down the information on paper. 

Instrument qualification is required to establish the functional capability and reliability of a system for its intended use in a suitable environment. Instrument qualification can be divided into three stages installation, operation, and performance qualifications. A qualification protocol that provides details about the system, the scope and constraints of the qualification, qualification tests, test procedures, and acceptance criteria should be available for review and approval before qualification begins. Sufficient time should be provided for review and approval. The protocol should also contain an exception log to record any out-of-specification results, investigation, and problem resolution. 

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... 

Installation qualification document (For computer systems, this should include an installation verification test report)... 

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. 

Installation qualification is defined in the PIC/S document PI 006 as The performance and documentation of tests to ensure that equipment (such as machines, measuring equipment) used in a manufacturing process, are appropriately selected, correctly installed and work in accordance with established specifications. ... 

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. 

Once the hardware installation qualification protocol has been completed, the test results, data and documentation are formally evaluated. The written evaluation should be presented clearly and in a manner that can be readily understood. The structure of the report can parallel the structure of the associated protocol. The report should also address any nonconformances encountered during the hardware installation qualification, and their resolution. The hardware installation qualification report summarizes the results of the verification and testing of all hardware technologies that are part of the system. 

All installation qualification activities and resulting data must be verified by a second (independent) person. Evidence of verification activities may be confirmed by signing of the corresponding data collection form verification activities must include the date on which the activity was performed. The reviewer s signature indicates that the test was completed as expected, that the acceptance criteria were met, and that the appropriate documentation/ evidence (if applicable) was collected. 

The impact of new versions of firmware and software on the validity of the existing qualification documentation should be reviewed and appropriate action taken. If applicable, after the new version is installed, regression testing should be conducted. The results of the regression test must be documented and approved by the appropriate personnel. 

Category 7—minimal monitoring. Example Supplier customizes a formulation tank. Sponsor reviews and approves the blueprints prior to manufacturing. An installation qualification and operational qualification is planned upon receipt to verify acceptability. Category 2—Enhanced monitoring. Example Well-known supplier of containers/closures supplies multiple lots per year of vials to the sponsor. The sponsor has no historical quality concerns with the supplier. Testing will be conducted upon receipt to verify acceptability of materials. 

Design Qualification (DQ) is the first validation element of a new facility system or equipment, where adherence to the user s specifications and to GMP rules is demonstrated. Installation Qualification (IQ) follows with the verification of adequacy of the area, installation of equipment pipelines, utilities, instrumentation, and conformity of the material used to the project specifications. At the Operational Qualification (OQ) phase, carried out after installation of all equipment, it is verified whether the system, when in operation, complies with the acceptance criteria defined in the validation plan. Once the OQ phase is successfully finalized it is possible to proceed with the calibration procedures, operation and cleaning, operator training, and preventive maintenance program. After IQ and OQ are concluded, it is time for the Performance Qualification (PQ), with the aim of verifying that what was designed, built, and operated results in a product that meets the expected specifications. Production and QC personnel are specially trained for these assessments. The tests can be done with the product of interest or a placebo, and are related to all operations, from raw material reception to product release (EC, 2001). 

The Installation Qualification Report is therefore a milestone in the project which completes the IQ and records acceptance that any outstanding issues are of a nature that will not affect the integrity of the operational testing. 

Following the execution of the OQ tests there may be issues noted that the LIMS does not function in accordance with the design as agreed upon during the Design Review process. As for the Installation Qualification Report the project team will need to review these failures and determine a plan of action or a justification for moving on to the next phase. 

The loop test results should be recorded (a sample instrument loop check sheet has been provided for reference purposes in Appendix 23D) and included with the site test records. Checks for mechanical/electrical completeness are recorded using the upper section of the sheet and the dytramic loop test results are recorded on the lower section. The test results sheets will provide the documentary evidence essential for Installation Qualification (IQ). Representatives from the installation contractor and/or the customer will witness the final loop tests and countersign the test sheets. Any tests not witnessed must be accompanied by written confirmation from the customer that witnessing has been waived. 

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