Suitability criteria

The unknowns in this equation are the local coordinates of the foot (i.e. and 7]). After insertion of the global coordinates of the foot found at step 6 in the left-hand side, and the global coordinates of the nodal points in a given element in the right-hand side of this equation, it is solved using the Newton-Raphson method. If the foot is actually inside the selected element then for a quadrilateral element its local coordinates must be between -1 and +1 (a suitable criteria should be used in other types of elements). If the search is not successful then another element is selected and the procedure is repeated. 

An important part of the hazard identification procedure shown in Figure 10-1 is the risk acceptance step. Each organization using these procedures must have suitable criteria. 

To validate the suitability of methods, experiments to establish specificity, accuracy, precision, limits of detection, limits of quantitation, linearity, range, and robustness should be conducted. Furthermore, appropriate system suitability criteria should be developed to assure that the method is performing to pre-established criteria at the time of use. 

Appropriate system suitability is very important for CE assays in a QC environment. It is preferable to define CE-specific system suitability criteria rather than directly adopt system suitability based on HPLC methods. Earlier data from biotech companies showed a high assay failure rate due to inappropriate system suitability criteria. When appropriate criteria were applied in the QC environment, the assay failure rate improved. 

The robustness of an assay becomes critical when evaluating its performance in a QC environment for the release of therapeutic proteins and antibodies. Over the past 5 — 10 years of product release experience in the biotech industry, assay failure rate is in the range of 5—30% depending on the method type and system suitability criteria. The types of assay failure are mainly as follows technical error (including analyst error), equipment error, and system suitability/assay acceptance errors. A periodic review of an assay s performance in the QC labs and timely feedback to the development labs are crucial to minimize the assay failure rate. A concerted effort in working with vendor is also helpful to ensure that instruments are in good condition to minimize the assay failure rate. 

When necessary giving advice for improvement of the performance of the method and definition of suitability criteria. 

Other results obtained from the ruggedness test are the definition of optimized method conditions for the factors and of system suitability criteria for a number of responses. System suitability parameters [6,17] are defined as an interval in which a response can vary for a rugged method. The system suitability criteria are the range of values between which a response (e.g. retention time, capacity factor, number of theoretical plates, resolution) can vary without affecting the quantitative results of the analysis. For instance, a design is performed and the retention time of the main substance varies between 200 s and 320 s without affecting the quantitative determination of the substances. The system suitability criteria for the retention time is then defined as the interval 200 s - 320 s. 

The specification of system suitability criteria. These are a set of conditions that an instrumental set up must meet before it can be used for the method. They usually consist of a range of values for... 

The flow rate caused a large effect on peak areas with a 25% decrease causing a 17% increase in observed peak areas. This indicates that flow repeatability of an instrument must be better than 1.5% and ideally around 1% to achieve acceptable results from this assay procedure. Results also show that solvent evaporation and temperature changes need to be minimised to reduce the effects of drifting method conditions. The system suitability criteria for this method had to be derived excluding the results achieved for the non-rugged Techsphere column and are shown in Table 5.24. A fuller description of the results for this study can be found in reference [26]. 

In order to obtain universal analytical solutions for state transfer in the presence of non-Markovian noise sources, we here discuss suitable criteria for optimizing the state transfer in such cases. 

The complete and assembled component and its parts should meet suitability criteria appropriate for the drug product and the actual use of the component. Safety and functionality are the most common factors to be established for suitability. The length of time that the associated component and the dosage form are in direct contact should also be taken into consideration when assessing the suitability of an associated component. 

If analytical measurements are susceptible to variations in the analysis parameters or sample preparation conditions, the method must be suitably controlled or a precautionary statement must be included in the written procedure that alerts the chemist to the susceptibility. The method s system suitability parameters should be defined in such a way that meeting all system suitability criteria would ensure that the method is currently being performed within the acceptance window provided by validation robustness testing. 

The system suitability criteria for resolution, peak tailing, and plate count must be met for both injections of the resolution solution. 

All system suitability criteria for injection reproducibility, standard confirmation, resolution, sensitivity determination, and peak tailing must be met on each day. 

Should assure that all method system suitability criteria have been met before it is used in the testing... 

Single- and Multiple-Feature Criteria. Suitable criteria or indices of thermal stability should be uniquely and consistently available from the thermogram patterns for any of the materials to be analyzed. The values should not be unduly disturbed by features of the thermogram not related to thermal stability such as early moisture content loss. Criteria for stability may be conveniently divided into two groups, those in which a single feature is used and those in which cumulative data or multiple features are used. One of the difficulties of most single-feature... 

Prior to performing a formal validation, the analytical chemist should have performed some prevalidation during method development. The expectation is that a well-developed HPLC method should subsequently be validated with no major surprises or failures. Prior to validation, specificity and some degree of robustness should be demonstrated. In addition, some form of system suitability criteria will have been established. System suitability evaluates the capability of an HPLC system to perform a specific procedure on a given day. It is a quality check to ensure that the system functions as expected and that the generated data will be reliable. Only if the system passes this test should the analyst proceed to perform the specific analysis. System suitability can be based on resolution of two specified components, relative standard deviation, tailing factor, limit of quantitation or detection, expected retention times, number of theoretical plates, or a reference check. 

Miller, J.H.McB. System suitability criteria—a case study 48. 

Evaluation of suitable criteria for the definition of the end of a bum cycles and a test cycle respectively. 

To address the above mentioned "suitability criteria" this paper introduces the concept of "Rating Indices", which is based on the desirable properties of the products for a particular application. 

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