Installation Qualification Protocols

The Installation Qualification (IQ) verifies that the equipment or system and/or corresponding utilities are installed in accordance with design specifications, manufacturer recommendations, and cGMPs. In addition, the IQ will confirm that critical instruments are calibrated and that system components are properly identified. Any exceptions will be documented, corrected, and/or justified. 

Where possible and applicable, pre-shipment inspection of equipment and documentation is included as part of the Installation Qualification. 

Pre-shipment inspection can be performed along with vendor audits to address issues such as software development and quality assurance plans, operational reports, and specific vendor/purchaser inspection reports. 

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

IQ = Installation Qualification OQ = Operational Qualification PQ = Performance Qualification 

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Table 2 Installation Qualification Protocol List of Essential Items... 

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. 

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. 

Preparation of the installation qualification protocol, if applicable, which includes... 

Systems and equipment should be correctly installed in accordance with an installation plan and installation qualification protocol. 

Format for an installation qualification protocol and report (continued) ... 

QA004 Installation qualification protocol format and requirements for software... 

IQ Installation Qualification protocol OQ Operational Qualification protocol PQ Performance Qualification protocol PV Process Validation protocol PM Preventive Maintenance procedure... 

Enhanced turn-over package Installation qualification protocols Operational qualification protocols Change control initiation Cycle development Performance qualification protocol Process validation protocols Validation final reports Validation package Certificate for use in manufacturing Required protocols and procedures for dry production Required protocols and procedures for liquid and semisolid products... 

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). 

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—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... 

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. 

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 ... 

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. 

It is essential that an environmental chamber be qualified at its intended range of use prior to commissioning for routine operation in a stability program. A qualification protocol should be prepared describing the qualification procedures and must include predefined acceptance criteria for successful qualification. The qualification consists of three components an installation qualification, operation qualification, and performance qualification. 

As summarized above, the procedure for qualifying equipment begins with a protocol that describes the qualification activity. Qualification of equipment begins with an installation qualification, which is followed by operation qualification and concludes with performance qualification. 

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. 

Typical programs begin with installation qualification (IQ). The IQ is described in a written protocol that contains the following key elements ... 

The protocol must include the clarified purpose of each item, such as design verification and installation qualification. For example, the purpose of cleaning validation is to avoid any contamination. 

All protocols, whether for IQ (installation qualification)/OQ (operational qualification) of new equipment or for validating a new process, have the same... 

To ensure that specific criteria are set for all critical parameters, protocols should be developed for installation qualification (IQ), operational qualification (OQ), and performance qualifications (PQ). Again, they are generally only prepared for any systems, processes, or equipment that are defined as critical. More important than how these concepts are prepared is that the application must be based on a sound scientific approach. 

The Installation Qualification (IQ) protocol stipulated that all required software be installed, but the protocol did not state what software was required. [FDA 483, 2002]... 

Many infrastructure components will be subject to standard build specifications, e.g.. Print Servers, Application Servers, Domain Servers, etc. As such, it may be possible to develop standard, reusable Qualification protocols that can be reexecuted each time a new server is built and installed. 

An important part of any validation protocol for NIR or other instrumental methods is the process of instrument qualification. In any GMP/GLP facility, instrument performance must be validated. This instrument performance validation, also called instrument qualification, involves three phases [9] installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). 

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