Equipment/systems qualification

Equipment/Systems Qualification. Qualification of the equipment in which the product is manufactured, the support services, and computer systems supporting the process. 

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. 

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. 

At this point in the process, the equipment/system is able to be put into routine use. The final Q in the model, Performance Qualification, PQ, is about on-going compliance. Elements of PQ include a regular service programme, performance monitoring with warning and action limits (as defined in OQ). All of these elements need to be documented and individual log books for systems are useful for this purpose. PQ data should be subject to regular peer review. All instrument systems should be subject to a simple change procedure which may well be connected to the equipment log system. 

A validated manufacturing process is one which has been proved to do what it purports or is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment, systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. 

In the case of a computer system applied to a live manufacturing process and integral with plant equipment and the process itself, the project validation plan should specify the relationship of the computer system qualification activities and documentation with that of the corresponding plant equipment qualification and process validation. Indeed, the qualification activities and documentation of these elements of a computerized operation are sometimes combined. 

Equipment qualification—Definition of the equipment, system, and/or environment used for the process. These data are used to gather a baseline of the installation/operational condition of the system at the time when the performance qualification (PQ) of the system is performed. This baseline information is used to evaluate changes to the system performance over time. Intentional changes from these initial conditions must be considered and evaluated to establish that the system s performance is unaffected by the change. Unintentional changes in the form of a component or equipment malfunction or failure can be easily rectified using the available baseline data as a basis for proper performance. 

Proper functioning and performance of equipment play a major role in obtaining consistency, reliability and accuracy of analytical data. Therefore equipment should be properly selected, designed, installed, and operated, and the correct function and performance should be verified before and during operation. This holds for equipment hardware, computer hardware, hardware interfaces, and software and computer systems. Qualification of equipment hardware is well established and has been described by several authors [1-4], and typically users in analytical laboratories are quite familiar with testing equipment for hardware specifications. 

Prepare an Operational Qualification Report. This should include date study initiated date completed observations made problems encountered completeness of information collected summary of deviation report results of control/alarm tests sample data if appropriate location of original data other information relevant to the study and conclusions on the validity of the equipment/system operations. 

Equipment selection is often based on performance specifications, pricing, features, or vendor s technical or service support. Major companies tend to purchase HPLC from one or two vendors to reduce cost in system qualification, equipment service, and operator training. The compatibility to an existing chromatographic data-handling network often dominates the purchase decision for HPLC equipment. 

Qualification of equipment—The qualification of BPC process equipment including reaction vessels, receivers, crystallizers, centrifuges, dryers, filters, distillation columns, solvent distribution systems, etc. is a well-defined activity. While this equipment is somewhat different in design and operating features, than the dosage form equipment that has been the subject of the majority of papers on the subject, the same general principles apply. Reaction vessels, receivers, and crystallizers differ only minimally from formulation and water for injection tanks. Some BPC dryers are identical to those utilized in tablet departments. Solvent distribution systems are piping systems and may resemble WFI distribution systems. Some pieces of equipment such as distillation columns... 

The Facility Supervisor and Hot Cell Operators are qualification positions requiring successful completion of a formal training program before an individual Is allowed to operate specific HCF equipment and/or controls unsupervised. Proficiency for the qualified positions is demonstrated by minimum acceptable scores on written tests and by observation of the individual s operating skill with manipulators, production process equipment, and plant safety equipment and safety systems. Qualification also requires demonstrated adherence to conduct of operations principles, ability to follow procedures, and commitment to cultivating an environment of teamwork and continuous improvement. Staff contributions to improvement of procedures and processes are actively encouraged as a way to enhance the safety and work culture. 

Some medical device manufacturers are confused with the requirements for an equipment performance qualification (PQ). In general, a PQ is not required for manufacturing equipment if its performance is demonstrated during process validation (PV) where the equipment must be shown to perform under the unique conditions of every product (or range of products). A separate equipment PQ is only required when it is used in a manufacturing support role, which typically includes compressed air systems, clean rooms, and purified water systems. 

The documents described, namely, System Qualification Procedures (SQPs) and Standard Operating Procedure (SOP) in Figure 1 contain a generic risk assessment for determination of the validation scope and effort on the equipment lyophilizer. They were also used as a generic validation master plan for the project. Management of the project resources, costs, and deadlines was performed with a model created in a standard project planner. 

The process for equipment qualification is documented in the Aventis Behring (AB) System Qualification Procedure for lyophilizers. 

Approach to possible plant hardware modifications that could be identified during the development/implementation of new procedures (enhancement of instrumentation and control (I C), modifications of control systems, qualification of certain equipment, etc.) ... 

INTERNATIONAL ELECTROTECHNICAL COMMISSION, Nuclear Power Plants/Electrical Equipment of the Safety System — Qualification, Rep. lEC 60780,2nd edn, lEC, Geneva (1998). 

This subsection addresses the evaluation of the models and methods used to develop the floor response spectra (FRS) used for piping and equipment seismic qualification and seismic loads acting on structures. All of the systems required for restart are contained in the reactor building, the stack building, the cooling water reservoir (186 Basin), and the process effluent sump structure. 

Recommended practices for seismic qualification of electrical equipment of the safety system for nuclear generating stations ... 

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

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). 

Design qualification is of most relevance for systems that involve custom-design such as the facilities themselves, vhere it is necessary to demonstrate that the design complies vith GMP requirements. For simpler off-the-shelf equipment it is usually only a matter of selecting the correct equipment for the intended use. 

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. 

An organized document filing system must be maintained. This could be a paper file, an electronic document file, or a mixture of both. The equipment inventory system contains key information on the components of each system, their performance criteria and maintenance and calibration status. All documents including installation and performance documentation, as with other documents necessary to demonstrate the quality of the data, include SOPs for the qualification procedures, calibration, maintenance, personnel training, etc. If the manufacturer s operating, service, or maintenance manuals are used or cited in the operating procedures, copies of these manuals should be maintained. To facilitate retrieval, documentation should be stored in a central location and be indexed for easy retrieval. 

It is always recommended that OQ is carried out after a service visit. Evidence of continued satisfactory performance during use (PQ) should be obtained from everyday method-related checks (e.g. system suitability testing, calibration and analytical quality control). It is advisable to set up thresholds outside of which the performance of an instrument is no longer acceptable. Each stage of the equipment qualification needs to be fully documented so that the evidence of performance at any given time can be checked. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

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. 

A. When developing a dissolution method, the design qualification is built into the apparatus selection process. The dosage form and delivery system process will dictate at least initially the equipment of choice. For example, the first choice for a beaded product may be United States Pharmacopeia (USP) Apparatus 3, which is designed to confine the beads in a screened-in cylinder. 

Validation of automated systems must demonstrate a lack of contamination or interference that might result from automated transfer, cleaning, or solution preparations procedures. Equivalency between the results generated from the manual method and the data generated from the automated system should be demonstrated. Since sensitivity to automated dissolution testing may be formulation related, qualification and validation of automated dissolution equipment needs to be established on a product-by-product basis (8,13) (see also Chapter 12 for a more detailed description of automation issues). 

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