Installation Qualification documentation

The goal here is to summarize the installation qualification document. This includes ... 

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

Installation qualification— Documentation that the equipment was manufactured and installed in accordance with the intended design. This is essentially an audit of the installation against the equipment specifications and facility drawings. 

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 ... 

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 ... 

Qualification of the installations to document the ability of the equipment to operate the process described in Section 6.2.2... 

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. 

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. 

Installation qualification (IQ)—documented verihcation that the system, as installed or modihed, complies with the approved design. 

The standard of any facility of operation is highly dependent upon the quality of the design and, therefore, the staff employed to undertake the work. A design qualification protocol, or report document, should detail and record the disciplined, structured approach followed. This will provide a useful lead into the installation qualification (IQ) stage. 

The documentation (installation qualification, operational qualification, etc.) established prior to initiating validation studies provides the foundation for the subsequent validation. A comprehensive steam sterilization protocol should include the following items ... 

Most of these setpoints are fixed by the supplier, detailed in the purchase order, or are part of the installation qualification file. If the setpoints are fixed by the supplier, there are no acceptance criteria unless the supplier documents the setpoint in written form. When available from supplier s documents or when specified in the bill of order or the installation qualification report, the observed setpoints shall be compared with the documented ones. Any detected discrepancy is mentioned for investigation, justification, approval, or correction. When reported parameters are neither specified nor approved, they shall be mentioned as not specified. 

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]. 

Installation Qualification Installation qualification provides documented evidence that the instrument was received and successfully installed in accordance with the approved design requirements and properly installed in an environment suitable for its operation. Proper installation is the first step to ensure that the instrument will function properly. An improperly installed instrument is likely to cause problems during the operational qualification and performance qualification. The following are some checks for the IQ process ... 

Equipment System Validation The GMP has special features regarding the equipment, setting several points for the validation, such as design qualification, installation qualification, operational qualification, and performance qualification. Each point must be given in a different document, so four documents must be generated for each equipment. Without any of these documents, the equipment cannot be considered adequate for GMP purposes. GMPs do not refer equipment validations nonetheless, they refer these four items, and therefore, equipment can only be considered validated after the approval of these four documents. 

Installation Qualification After equipment selection, it is necessary to assure that the equipment is installed well. The IQ document describes and validates the procedure of the equipment installation. It establishes confidence that the process equipment and ancillary systems are capable of consistently operating within established limits and tolerances [10]. The equipment manufacturer and pharmaceutical company must agree and check the IQ, which must be approved by the pharmaceutical company at the end. This document certifies that equipment was installed as specified by the manufacturer and the purchaser. 

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. 

Often the equipment used to run the analytical methods must also undergo some type of qualification. It is suggested that installation qualification activities be performed at the very least. Many laboratory methods must undergo a calibration before each use, which can serve to eliminate the need for operational and performance qualifications. Again, all of the related analytical calibration/ qualification/validation activities performed must be documented. 

The Installation Qualification consists of a description of the lyophilization equipment, a system hardware and component list, the documentation of the installation procedures, and the equipment start-up and operator training. The IQ also includes references to the purchase specifications, engineering review, and SOPs. The objectives are to assure that the equipment design and construction are appropriate for the intended use, it is installed properly, the utilities are suitable and adequate, and that procedures are in place for proper maintenance and operation. 

The decision as to which system needs to be qualified should result directly from the risk analysis process and should be described in the VMP or QMP. In any case, it would be a technical system that impacts on the quality of a pharmaceutical product. Installation qualification aims to check documentation against reality. The result is as-built documentation. The other task in the IQ is to ensure that the GMP requirements are fulfilled. The generally accepted way to perform an IQ is to... 

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. ... 

Installation qualification is documented verification that the computer system (including all required software) is installed satisfactorily and is compliant with appropriate engineering codes, manufacturer recommendations, and approved specifications, and that the instrumentation is calibrated and all services are available and of adequate quality. 

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. 

Qualification activities are usually undertaken in order to characterize a facility s services and utilities as well as the equipment that would be used as part of a manufacturing process. As indicated earlier, these activities will include installation and operational activities as part of the validation function. Most companies will issue a report that documents the features of the facility s processing rooms, such as the electrical, water, gas, and HVAC services, for the installation qualification. Table 5 is a generic outline of the items that would be found in the IQ report. Whenever the process equipment is permanendy fixed in these rooms, the report will also list the equipment as well as its operating requirements and features. See Table 6 for an outline of questions that would be used to complete a report, which includes equipment qualification. It is preferred that qualification occur as soon as the equipment or facility is ready for routine operation so that any unexpected results will be corrected by the equipment vendor and/or construction contractor. 

Equipment—proper design and sizes for the project, use and cleaning records, documentation to show proper installation and operational qualification (equipment qualification EQ), and in some cases performance qualification documents, validated computer systems, preventive maintenance program, records of equipment repairs and upgrades and subsequent requalification documentation, etc. 

Most firms today start by qualifying each subsystem. To qualify, of course, means to establish convincing evidence that something happens as intended, which matches the validation definition (in more explicit terms, however). Installation qualification may be defined as documented verification that all key aspects of the installation adhere to manufacturer s recommendations, appropriate codes, and approved design intentions. Operational qualification is documented verification that a system or subsystem performs as intended throughout all specified operating ranges. 

Hardware installation qualification of the computer technology provides documented evidence of a high degree of assurance that the hardware has been installed according to an appropriate and approved technical design specification, and the hardware supplier s installation manual(s). Appropriate personnel must conduct the installation qualification of the computer systems hardware. 

If a validation plan is available, the hardware installation qualification should be addressed in this plan. If there is no validation plan, the hardware installation plan may be addressed either in a standalone document or as part of the installation qualification protocol. The hardware installation qualification plan identifies the activities to be completed and the responsible parties involved. 

The installation qualification will include, but will not be limited to, the following technologies/documentation ... 

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. 

The Hardware Installation Qualification Report can either be a standalone document or may be incorporated into the overall system qualifications summaiy report. 

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. 

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