Qualification equipment performance test

All processes and equipment should be proven capable of performing the task for which they were designed and so should either be subject to qualification tests or process capability tests. There may be documentation available from the supplier of the equipment which adequately demonstrates its capability, otherwise you may need to carry out qualification and capability tests to your own satisfaction. In the process industries the plant is specially designed and so needs to be commissioned and qualified by the user. Your procedures need to provide for such activities and for records of the tests to be maintained. 

Thus, while a well-maintained instrument is important for any chemical/physical measurement, in NIR, without a concurrent standard for comparison, it is critical that the instrument be continuously calibrated and maintained. Since the major manufacturers of equipment have worked with the pharmaceutical industry, this has been formalized into what is called IQ/OQ/PQ, or Instrument Qualification, Operational Qualification, and Performance Qualification. The first is routinely performed (at first) by the manufacturer in the lab/process location, the second in situ by the user with help from the manufacturer, and the third is product/use dependent. These formal tests apply to all instruments in any industry. 

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. 

For the purposes of instrument qualification, the PQ involves testing the equipment for overall system functionality. For dissolution equipment, these tests verify that the equipment can perform the entire dissolution process. A sample method should be observed to run properly. This can include running actual chemistry and analyzing the data results. 

Due to the nature of the specialized equipment that is required to perform these tests it is usual for the supplier to be asked to carry out the tests on behalf of the user. This would normally be performed as part of the initial installation or after a routine maintenance of the instrument. Following this the user would perform the rest of the initial qualification or periodic testing covering the other aspects of the instrument. 

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]. 

All the equipment qualification documents must define the equipment designation, tests to be performed, test specifications, materials, operators, reviewers, and responsibility for approval. 

Qualification or validation begins with a protocol or plan that describes fully the approach, including the scope, description of equipment, utilities, test methods, acceptance criteria, etc. The approved protocol is then executed by performing the requisite number of replicates as specified in the protocol and gathering the indicated data. The final step is the preparation and approval of a report containing the findings of the activity against the acceptance criteria found in the protocol. 

The PV of a new facility [21] must be documented in such a way to ensure that the facility s design and the operations within it are fully covered. An outline of such activities is listed in Table 4. For example, the validation of a new facility makes it necessary to document the equipment performance under relevant conditions. All process (or facility) equipment will undergo IQ testing to make sure that each piece of equipment operates as it was designed to do. The technologist will determine how the equipment s performance will vary without the influence of the process material (OQ). This information will form the basis for the remainder of the validation report. From a QA viewpoint, it should also be noted that this information might be useful if it is compared against the parameter measurements under load conditions. Since this information is more properly included in the performance qualification (as process optimization), however, it should not become a part of the validation protocol... 

It is important that equipment qualifications simulate actual production conditions, including those that are worst-case situations. Tests and challenges should be repeated a sufficient number of times to assure reliable and meaningful results. All acceptance criteria must be met during the test or challenge. If any test or challenge shows that the equipment does not perform within its specifications, an evaluation should be performed to identify the cause of the failure. Corrections should be made and additional test runs performed, as needed, to verify that the equipment performs within specifications. 

It is essential that the validation program is documented and that the documentation is properly maintained. Approval and release of the process for use in routine manufacturing should be based upon a review of all the validation documentation, including data from the equipment qualification, process performance qualification and product/package testing to ensure compatibility with the process. 

User/site acceptance testing of compnterized systems (known as qualihcation) must cover installation, operation, and performance in the wider system context inclnding equipment, processes, and operator interaction (i.e.. Installation Qnalihcation, Operation Qualification, and Performance Qualification). 

The tests will be broken into Hardware Acceptance Tests (or Installation Qualification), System Acceptance Tests (or Operational Qualihcation), and Equipment Tests (or Performance Qualihca-tion). According to the size of the unit, all tests may be in one test document or there may be three separate Qualification documents. A test document will define the test philosophy and how the tests should be run. Each test will have a tide, a reason for the test, an oudine of any test equipment required, a description of the test, data to be recorded, and the test acceptance criteria. Calibrated test equipment must be supported with cahbration certificates. 

The frequency of PQ depends on the type of instrument, on the stability of the performance parameters, on the specified acceptance criteria, and on the use of the equipment. The test frequency for PQ is much higher than for OQ. Performance qualification is always performed under similar conditions to establish a routine sample analysis that is, using the same column, the same analysis conditions, and the same test compounds. PQ should be performed on a daily basis or whenever the instrument is used. For a liquid chromatograph, the most important unit... 

Operational qualification (OQ) for testing the equipment to ensure that it meets the previously defined functional and performance specifications... 

Describes what the equipment or system is supposed to do and, as such, is normally written by the pharmaceutical manufacturer. This links to Performance Qualification (PQ) which tests the user requirements. 

The review of equipment qualification should determine (a) whether assurance of the required equipment performance capability was initially provided and (b) whether equipment performance has been preserved by ongoing application of measures such as scheduled maintenance, testing and calibration and has been clearly documented. It should be noted that a review relating to (a) above may not be necessary if a previous review has concluded... 

It is preferable that qualification be achieved by the testing of prototypical equipment (type testing). This is not always fully practicable for the vibration of large components or the ageing of equipment. In snch cases extrapolation of equipment performance nnder similar conditions, analyses or tests pins analyses should be relied upon. 

As the cost of testing vast quantities of equipment would be too great and take too long, qualification tests, particularly on hardware, are usually performed on a small sample. The test levels are varied to take account of design assumptions, variations in production processes and the operating environment. 

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. 

During the dissolution test, the hydrodynamic aspects of the fluid flow in the vessel have a major influence on the dissolution rate (1). Therefore, the working condition of the equipment is of critical importance. In this chapter, the qualification and calibration of the equipment referred to in the two USP General Chapters related to dissolution, < 711 > Dissolution and < 724 > Drug Release (2), will be discussed. Sources of error when performing dissolution... 

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 manufacturer often creates an instrument qualification plan and provides installation, operational, and performance qualifications to be executed in the customer s laboratory. The company using the equipment must determine if the manufacturer supplied instrument qualifications is comprehensive enough to be sure that the equipment is installed, operating, and performing correctly. If they feel it is not, they may choose to perform more tests themselves. 

Ensure that performance qualification testing has been carried out using the same personnel who will routinely operate the system or equipment... 

The performance qualification of computerized control systems consists of a group of tests pooled in functional checks. The tests shall be carried out on the integrated system. The structure of the performance qualification shall be standardized for all performance qualification of computerized pharmaceutical equipment. 

Validation protocols are required to describe the objective, methodology, and acceptance criteria for installation, operational, and performance qualifications. They are written to ensure test methods, and acceptance criteria are reviewed and approved before qualification of protocols. In practical terms, there are several stages for the production of protocols. First, an acceptable format needs to be agreed. No universal format exists for protocols, but to some extent, the type of equipment, the size of the project, and the personal preferences will dictate the protocol style. However, some norms have been established. Like other controlled documents, protocols are assigned unique reference numbers and revision numbers. They are titled and numbered on every page and have a particular place for approval signatures. Other common elements in protocols tend to be brief descriptions of the item being qualified and a clear statement of responsibilities. 

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