Test requirements description

Motivation Unit tests require a substantial investment in time and resources to complete successfully. This is the case whether the test is a straightforward analysis of pump performance or a complex analysis of an integrated reactor and separation train. The uncertainties in the measurements, the likelihood that different underlying problems lead to the same symptoms, and the multiple interpretations of unit performance are barriers against accurate understanding of the unit operation. The goal of any unit test should be to maximize the success (i.e., to describe accurately unit performance) while minimizing the resources necessary to arrive at the description and the subsequent recommendations. The number of measurements and the number of trials should be selected so that they are minimized. 

Validation Team A well-defined validation team with a well-written description of responsibilities is required and assures the adequate realization of the validation tasks. A validation team should be composed by different responsibilities responsible-of-validation team, team leader, archive manager, test coordinator, quality assurance member, tester, and witness. The responsible-for-validation team elaborates and approves the VMP, protocols, and reports. The team leader should be responsible for the computer system validation and utilization. An archive manager is responsible for the management of all computer system validation documents. The test coordinator is responsible for the computer system test and coordinates the elaboration and operation of tests for evaluating the performance of the computer system. A quality assurance member is required to periodically inspect and train the personnel and review all the validation documents. The tester is responsible for the execution of the tests required to perform the validation protocol. The witness is responsible for observing and reviewing the operations of the tester. 

In-process testing is especially critical, if the material being produced is to be used for human consumption. The types of in-process testing requirements will vary with the process. However, following is a brief description of the types of the in-process testing requirements of a solid-dose manufacturing process. 

Requirement Description Limit Test Quantitative Test... 

The sensory method chosen for a test is dependent on the type of information required. The appropriate method can only be selected after the objectives of the test are clearly defined. As illustrated in Table 1, there are a substantial number of test methods available and it is important to be familiar with them in order to apply the correct method to achieve the correct results. Familiarity with the test methods also reduces the likelihood of relying on a single method. Difference and descriptive tests are the main tests used to evaluate fat and oil quality. Both tests require the use of trained panelists, but the level of training is considerably more for descriptive testing. In difference testing, panelists only determine if there is a difference between samples. The degree of difference is not determined. In contrast, descriptive tests allow panelists to rate the intensities of several attributes resulting... 

Abstract Quality control of corrosion test results implies the validation of the corrosion test method and estimation of the uncertainty of corrosion rate measurement. The corrosion test in an artificial atmosphere of the salt spray mist needs evaluation of corrosivity of the test cabinet by reference specimens. Such calibration of corrosion environment raises very strict requirements for the method description and details of all procedures and used specimens. Reliable corrosion measurements by spray tests require validation of the experimental device together with the experimental procedure and determination of corrosivity uncertainty of the test cabinet environment. 

The validation results require changes in the salt spray test method description and maybe in the performance. 

Bloassays. House fly larvicide tests required a modified (1 7 ), semi-defined (1J5) synthetic diet to rear larvae. A brief description of the test method follows. Fifty freshly deposited eggs (from NAIDM strain of flies) were placed on top of a gel matrix comprised of water (8 ml), synthetic house fly diet (1.5 g), vitamin mixture (0.5 ml), and test compound at the required concentration. Resulting larvae were allowed to develop in the gel (held at 27°C for the duration of the test) to the pupal stage and pupae that survived treatment were counted. From counts, percent inhibition of pupation was calculated. Scoring system (based on percent inhibition of pupation) 0, normal... 

Description of all tests required for quality control and of the analyses to be carried out during each production step as well as the name of the persons or services responsible for performing these tests and analyses. 

For this purpose the above-mentioned description for the clamped seam can be used - everything else has been retained unchanged. The test required (for detail see Fig. 5.5) is once more the single-axis, parallel-thread strip test. As mentioned above, it is essential to ensure that the clamps, etc., are also brought up to the testing temperature. 

Requirement Paragraph Requirement Description Test Method Paragraph... 

A sampling plan for attributes is a method to overcome this problem. An example of such a plan is the Accepted Quality Level system (AQL) (See Sect. 24.5.4. for a more complete description of AQL and Sect. 20.4.5 for a statistic background). In order for the AQL system to be successful an extensive and statistically planned random sample has to be selected. The defects that are found are classified into levels, for example critical, major, minor. Within each level the system defines an acceptable quality level . When a quality level is exceeded, then a batch should be rejected. This method of testing requires time and expertise. Sampling has to be performed from a large number of containers from the same batch. Within the pharmaceutical industry it is often necessary for such tests to be carried out by the container manufacturer. For smaller enterprises such as pharmacies quality control can be undertaken by the wholesaler or an independent laboratory. Within a (hospital) pharmacy the quality control is often limited to a visual comparison to reference samples and a check of the presence of the supplier s statement that the containers comply with the agreed specifications [46]. 

System testing is defined as when the development team is in charge of testing the entire system from the point of view of the functions the software is supposed to fulfill. The validation process is completed when aU tests required in the system test plan are satisfied. The development team will then produce a system description document. 

Proof test interval for SIF This is an important issue. Proof tests are meant to test the function as far as possible (could be dangerous in a shutdown condition). Major issues related to this shall include but not be limited to the following [12] Description of the proof test procedure Precaution and safety to be under taken for proof test Required proof tests in life cycle... 

All the calibrations and tests required for 2D quantitative /nn HNN-COSY spectrum have been described in the first protocol. The second protocoP contains the description of the details of 2D long-range H(N)CO TROSY pulse sequence along with the reference experiment sequence which accounts for relaxation losses. 

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