Installation qualification steps

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. 

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 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. 

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 ... 

Installation qualification (IQ) establishes that the instrument is received as designed and specified, that it is properly installed in the selected environment, and that this environment is suitable for the operation and use of the instrument. The following steps are recommended before and during installation. 

Installation Qualification. Installation qualification (IQ) is a process to establish tliat die instrnment was received as specified and installed properly according to die design requirements in an environment suitable for its operation. Proper installadon is die first step to ensure proper fnnctioning of equipment. Typical IQ activities include ... 

Action of proving and documenting that any premises, systems and equipment are properly installed and/or work correctly and lead to the expected results. Qualification is often apart (the initial stage) of validation, but the individual qualification steps alone do not constitute process validation. In the context of this document it is the work done to prove that the supply system will deliver products of the quality required and specified on a routine basis, meeting all the applicable quality requirements. 

Qualification Action of proving and documenting that equipment or ancillary systems are properly installed, they work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation. 

The system validation documentation includes but is not limited to Quality Assurance Plan (QAP), Operation and Maintenance Manual (O M), and Factory Acceptance Test (FAT) reports. A properly developed QAP and its supporting documentation help to reduce cost, boost product quality, ensure regulatory compliance and increase profitability. The FAT validation is the first verification step of the customer s validation process, which may include design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). 

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... 

The next step for the manufacturer often is on-site installation. The installation visit is set up once the laboratory has fully prepared the space for the instrument and has verified shipment status (complete, correct, and visually undamaget. Installation qualification includes generating a documented list of components and their serial numbers, establishing physical connections between all components, and generating a record of where and when the installation took place and by whom it was conducted. 

To ensure that equipment is fit for its intended purpose, there is a series of qualifying steps that the analyst or vendor should apply to analytical instrumentation (3,4). Equipment can be evaluated through a series of tests or procedures designed to determine if the system meets an established set of specifications governing the accepted operating parameters. The successful completion of such tests justifies that the system operates and performs as expected. There are four components of instrument qualification design, installation, operational, and performance. 

The developer (the person who did the installation and model development) leaves too soon - voluntarily or otherwise. The developer generally needs to maintain involvement well into the long-term prove-out or qualification phase (Step 8). Plant personnel who inherit process analyzer systems before qualification is complete may experience extreme levels of frustration, especially if they have no previous NIR experience and were not involved in the earlier stages of the project. Another way to state this factor is The business fails to adequately staff the project. 

The steps of checking design and construction, confirming proper installation and operation, and documenting these processes are collectively called qualification or validation. In case of any system change or changes to equipment, the same kinds of procedures should be implemented. 

A significant aspect of compliance is validation of the process through qualifications of the equipment installation and operation, process validation and, recently, the development of a cleaning validation. There are summaries describing how to qualify the installation and operation of equipment, piping, valves and instruments [84], The process validation requires evaluating the critical steps, which effect the quality and purity of the final active drug substance [85]. This involves development of a protocol, which states how the validation is to be conducted and defines the data to be collected. The most important part of the protocol is the development of acceptance criteria for the results. 

Abstract Installation and operational qualification are important steps in the overall validation and qualification process for software and computer systems. This article guides users of such systems step by step through the installation and operational qualification procedures. It provides guidelines on what should be tested and documented during installation prior to... 

The development of a VMP requires several decisions. If the facility is new, due consideration is given to determine, on time, the target dates for routine production to ensure completion of validation for facility approval otherwise manufacturing at risk is the alternative choice. The deadline determination provides ample opportunity to perform validation of utilities, critical equipment installation, and qualification prior to construction work. In addition, it provides a sufficient time frame to identify the critical processes and steps involved. The parameters critical for each step shall be established. The critical equipment required shall be determined. Critical processes, steps involved, parameters, and equipment are identified. For existing facilities, establish the criteria for revalidation based on known vulnerabilities and engineering projects in progress. 

The assignment of sta/Q and their organization is tightly linked with the processes and facility installations. On the one hand, the number and qualification level of the employees have to be determined on the other hand, the sequence of the single production steps has to be decided. Thus, the staff and organizational planning deals with the issues of work economy and organization. 

Validation must begin right back at the design stage as it is at this point that the specifications and operational limits of the system are defined. This preliminary step ensures that the equipment will be suitable for its intended function, and will not be adversely affected by its operating environment. Once the system is manufactured and installed it is subject to an installation and operational qualification (IQ/OQ), the objective of which is to determine that the equipment meets the defined specifications. 

---