Validated testing procedures

Validated test procedures with results of the validation studies. 

To select chemical programs for an oil-treating facility, each facility must be examined on an individual basis. The selection of a chemical or group of chemicals for emulsion breaking must be preceded by valid test procedures and a thorough understanding of the treating system and petroleum company objectives. 

An assay which is not in regular use requires sufficient revalidation to show that it still performs according to the original validated test procedures. The revalidation study must be documented, usually as an appendix to the study report. 

This form was designed specifically for routine analyses to test for the identity and purity of large numbers of pharmaceutically active ingredients and intermediates. The samples are weighed out on an analytical balance with no printer. All operating procedures are given in a valid testing procedure. 

This form was designed exclusively for stability samples of preparatory pharmaceutical products. In this case it should be assumed that a valid testing procedure is available, so that it is imnecessary to record the sample preparation method and the chromatographic conditions. Above all, it is important that the developed chromatogram should be checked for the possible presence of additional zones (AZs). The number and the intensity of each individual AZ must be documented. 

Testing activities are addressed throughout development, including an emphasis on development of validation test procedures as soon as the requirements are defined to provide early test capabilities. 

Other procedures for the evaluation of disintegration during composting in full-scale testing have been discussed in which the sample is introduced in net bags into a composting pile. However, national or international standards have not been published yet. In addition, for disintegration it is important to validate test procedures by the use of (natural) reference materials. 

Validation test procedures of each safety function in the logic solver. 

The development and validation of UTDefect has now progressed so far so that the program can be of real help in the development of testing procedures, in parametric and sensitivity studies and in such technical justifications that are used for qualifications of testing procedures. 

Uses raw data from field tests to compute hydraulic conductivity computed value is evaluated by the expert system for its correctness with regard to these considerations site-specific geological characteristics, validity of test procedures, accuracy of the raw data, and the computational method. System is written in Arity-Prolog on a PC. 

The stopwatch technique for determining emission volume flow rate is based on measuring with a stopwatch the elapsed time for fume to rise between two known levels (e.g., Zj, Z,). For this test procedure to be valid, the test must be carried out in a region where the rising fume clearly exhibits buoyancy-dominated plume behavior. The calculation procedure depends on a good estimate of the location of the virtual origin of the plume and the heat release for the process. 

We have said that every time the calibration analyzes a new unknown sample, this amounts to an additional validation test of the calibration. It can be a major mistake to believe that, just because a calibration worked well when it was being developed, it will continue to produce reliable results from that point on. When we discussed the requirements for a training set, we said that collection of samples in the training set must, as a group, be representative in all ways of the unknowns that will be analyzed by the calibration. If this condition is not met, then the calibration is invalid and cannot be expected to produce reliable results. Any change in the process, the instrument, or the measurement procedure which introduces changes into the data measured on an unknown will violate this condition and invalidate the method If this occurs, the concentration values that the calibration predicts for unknown samples are completely unreliable We must therefore have a plan and procedures in place that will insure that we are alerted if such a condition should arise. 

The validity of set I can be tested by ascertaining whether Eq. (39) is itself valid similar procedures are followed for the other sets of properties. 

Subcase b2 This case, called the paired f-test , is often done when two test procedures, such as methods A and B, are applied to the same samples, for instance when validating a proposed procedure with respect to the accepted one. In practicular, an official content uniformity" 5 assay might prescribe a photometric measurement (extract the active principle from a tablet... 

Even if most examples and procedures presented apply to in-house validation, the procedure does not distinguish between validations conducted in a single laboratory and those carried out within inter-laboratory method performance studies. A preference for inter-laboratory studies can be concluded from the statement that laboratories should always give priority to methods which have been tested in method performance studies. Within the procedure a profound overview of different categories of analytical methods according to the available documentation and previous external validation is given. For example, if a method is externally validated in a method performance study, it should be tested for trueness and precision only. On the other hand, a full validation is recommended for those methods which are published in the scientific literature without complete presentation of essential performance characteristics (Table 9). 

Since a device can fail at any time during its life, periodic proof tests are performed to demonstrate the functionality of the SIS. Proof tests are covered by operation and maintenance procedures that ensure that the test is done correctly, consistently, and safely and that the device is returned to a fully operational state after test. Each test serves as an opportunity for personnel to see the SIS in action and to validate the procedures associated with its operation. 

Some would say that this is the current state of the art. Much of the necessary library could be assembled from test systems that have been extensively evaluated and have already undergone extensive validation (Gad, 2000, 2001). Three critical steps must be taken for the eventual fulfillment of these objectives (1) acceptance of a scientific approach to the problem of safety assessment (2) development of an operative validation and acceptance process for new test procedures (3) clear enunciation of an acceptance criterion for new test designs by regulatory authorities. 

Sinkers can significantly influence the dissolution profile of a drug. Therefore, the use of sinkers should be part of the dissolution method validation. If equivalent sinkers are identified during the sinker evaluation and validation, the equivalent sinkers should be listed in the written dissolution test procedure. When a dissolution method utilizes a dissolution sinker and is transferred to another laboratory, the receiving laboratory should duplicate the validated sinker design(s) as closely as possible. 

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