Quality control identity tests

Therefore quality control (QC) testing of vaccines normally includes the following assays, which must be passed prior to material being released for use in preclinical toxicology studies sterility, endotoxin, general safety, identity, mass, potency, purity, and stability [62], These assays should be performed on the final product using the clinical formulation. 

This test shows the ability of a material to resist the action of an arc of high voltage and low current close to the surface of the insulation in tending to form a conducting path therein. The arc resistance data are of relative value only for distinguishing materials of nearly identical composition, such as for quality control, development, or identification. 

Solution viscosity measurements have sometimes been utilized as qioality control tests for this polymer. Chromatographs of three samples that showed Identical intrinsic viscosities (0.8 g/dl) in toluene are shown in Figure 9. These chromatographs indicate that the identical viscosities are the result of different combinations of high and low MW components. These three polymer samples probably have significantly different physical properties and if viscosity measurments alone are utilized for quality control purposes, they may be quite misleading. 

Apart from routine quality control actions, additive analysis is often called upon in relation to testing additive effectiveness as well as in connection with food packaging and medical plastics, where the identities and levels of potentially toxic substances must be accurately known and controlled. Food contact plastics are regulated by maximum concentrations allowable in the plastic, which applies to residual monomers and processing aids as well as additives [64-66]. Analytical measurements provide not only a method of quality control but also a means of establishing the loss of stabilisers as a function of material processing and product ageing. 

Method performance study All laboratories follow the same written protocol and use the same test method to measure a quantity (usually concentration of an analyte) in sets of identical test samples. The results are used to estimate the performance characteristics of the method, which are usually within-laboratory- and between-laboratory precision and - if relevant - additional parameters such as sensitivity, limit of detection, recovery, and internal quality control parameters (IUPAC Orange Book [1997, 2000]). 

NMR can also be used to elucidate the structural features of a repeating unit in a polysaccharide and to investigate the conformation and dynamics of polysaccharides.21 A unique polysaccharide structure results in a characteristic proton NMR spectrum. Therefore, NMR is a powerful tool for identifying polysaccharide structures. This remarkable specificity has led to the development of a routine NMR-based identity assay, recently reported by Abeygunawardana et al. for quality control testing of bacterial polysaccharide to be used in formulating a polyvalent pneumococcal polysaccharide vaccine.22... 

The physicochemical and other properties of any newly identified drug must be extensively characterized prior to its entry into clinical trials. As the vast bulk of biopharmaceuticals are proteins, a summary overview of the approach taken to initial characterization of these biomolecules is presented. A prerequisite to such characterization is initial purification of the protein. Purification to homogeneity usually requires a combination of three or more high-resolution chromatographic steps. The purification protocol is designed carefully, as it usually forms the basis of subsequent pilot and process-scale purification systems. The purified product is then subjected to a battery of tests, which aim to characterize it fully. Moreover, once these characteristics have been defined, they form the basis of many of the quality control (QC) identity tests routinely performed on the product during its subsequent commercial manufacture. As these identity tests are discussed in detail in Chapter 3, only an abbreviated overview is presented here, in the form of Figure 2.7. 

In many pharmaceutical companies, quality control departments already use NIRS to identify formulations. Figure 23 illustrates a PLS calibration for the active content determination in a low-dose tablet. Once identity testing is passed, it is straightforward to consider as a next step the determination of active content in intact tablets. Thus, qualitative and quantitative analysis can be performed by acquiring a single NIR spectrum per sample. Two analytical techniques are replaced by one—nondestructive—NIR measurement. For this purpose near-infrared spectroscopy is a fast and powerful alternative to traditional analysis, which only remains necessary as reference analytics. 

One of the most widely used forms of gel electrophoresis is known as sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE). Polyacrylamide gel has several advantages that account for its extensive use. It has minimal adsorptive properties and produces a negligible electroosmotic effect (Hjelmeland and Chrambach 1981). In identity tests, for the determination of molecular weight, SDS-PAGE has been shown to be an appropriate, fast, and easy method that is often used in quality control laboratories. The use of SDS-PAGE followed by a densitometric analysis, such as MS, is a helpful technique for the determination of peptide or... 

In the same way that tests based on arbitrary conditions are deficient for design data purposes, so they may tend to lack in their direct relevance to service conditions and, hence, their value for predicting service performance. The two situations are not identical, in particular a test may simulate service use to enable predictions to be made but not yield data which can be used in design calculations. Not only for product proving but also for quality control, there is increasingly demand for tests which are better in this respect. A prime difficulty is that as effort is made to make the method reflect service so it tends to become more complicated and more expensive. There are many instances in specifications where a more relevant test exists but is not used because it is more time consuming or complex. 

Quality control sample, often chosen randomly, from a batch of samples and undergoing separate, but identical sample preparation and analysis whose purpose is to monitor method precision and sample homogeneity. Duplicate testing also aids in the evaluation of analyst proficiency. Volume 1(10). 

In general the quality control procedures for products obtained through biotechnology are very similar to those routinely used with traditional pharmaceutical products in areas such as raw material testing, documentation of process control, and aseptic processing. The fundamental difference is in the type of methods used, so as to determine the product s identity, uniformity, and purity. In the quality control of products obtained through recombinant DNA technology, it is necessary to employ validated tests for the final and intermediary products to ensure the elimination of undesirable impurities. 

As with the quality control plan for the formulator described above, acceptance tests on adhesives should be directed toward assurance that incoming materials are identical from lot to lot. However, this plan should also extend to the receipt and control of incoming adherends and other materials used in the bonding process. 

The methods and technology used for quality control and the quantity of parameters checked can vary, depending on the cell type preparation and the final use of the cells. Cell viability, morphology, and proliferative capacity are common, easily tested parameters. Immunofluorescence studies with panels of antibodies raised against specific markers of the isolated cell type are commonly employed to provide proof of the identity and health of the cells. Additional tests, for example, specific enzymatic activity or expression levels of particular genes, can be also performed as routine quality control parameters when they are crucial to the subsequent use of the cells. 

The performance of a flexible PVC compound is often defined by its plasticiser content and composition and a simple, accurate and fast method of plasticiser identification could, therefore, be an effective quality control and benchmark performance test in new product development studies. Gas chromatography was shown to provide the most effective identification method and it was demonstrated that it could be complemented by IR spectroscopy, liquid chromatography and physical observations to confirm identity. 4 refs. 

The identity test is a very useful tool of quality control, for example in the pharmaceutical industry. The identity of two samples may be unequivocally established by a method described by Weitkamp and Wortig (1983). 

Finished component tests may be divided into three categories those used as routine identity and/or quality control tests, those tests recommended or mandated by government, standards, and compendial groups, and those test that are part of the larger rubber component acceptance and drug/device approval process. In many instances, a test may fall into more than one category. 

Quality assurance (QA) testing and recertification of LAF systems and other engineering controls, which support the aseptic process (process auditing), irrespective of quality control, or procedures to demonstrate conformance with product specifications of identity, purity, sterility, and apyrogenicity (product auditing). 

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