Quality Control Methodology

Chapters 17 through 20 describe the various processes and equipment employed in the formulation or end use of epoxy adhesives. Health and safety issues regarding the use of these materials are discussed. The importance of quality control methodologies and specification preparation is also noted. Finally, test methods that are commonly used by both the formulator and the end user are identified. 

The terms associated with quality control methodology are ... 

The system is manufactured based on design specifications. Quality control methodologies are essential during this step. All the parts, materials, and processes are controlled based on methodologies discussed in previous chapters in the area of quality assurance. One of the objectives of the quality control program is to make sure that the inherent reliability of the design is not degraded. 

Furthermore, Fig. 8.11 shows that the citric acid also interacts with direct dyes, resulting in the exhaustion of these dyes by the cotton fibres. The capability to capture such detailed information on dyes and their interactions with chemicals, fabric and process variables enables the dyer to develop a quality control methodology for a dyehouse. 

A solvent free, fast and environmentally friendly near infrared-based methodology was developed for the determination and quality control of 11 pesticides in commercially available formulations. This methodology was based on the direct measurement of the diffuse reflectance spectra of solid samples inside glass vials and a multivariate calibration model to determine the active principle concentration in agrochemicals. The proposed PLS model was made using 11 known commercial and 22 doped samples (11 under and 11 over dosed) for calibration and 22 different formulations as the validation set. For Buprofezin, Chlorsulfuron, Cyromazine, Daminozide, Diuron and Iprodione determination, the information in the spectral range between 1618 and 2630 nm of the reflectance spectra was employed. On the other hand, for Bensulfuron, Fenoxycarb, Metalaxyl, Procymidone and Tricyclazole determination, the first order derivative spectra in the range between 1618 and 2630 nm was used. In both cases, a linear remove correction was applied. Mean accuracy errors between 0.5 and 3.1% were obtained for the validation set. 

The determination and analysis of sensory properties plays an important role in the development of new consumer products. Particularly in the food industry sensory analysis has become an indispensable tool in research, development, marketing and quality control. The discipline of sensory analysis covers a wide spectrum of subjects physiology of sensory perception, psychology of human behaviour, flavour chemistry, physics of emulsion break-up and flavour release, testing methodology, consumer research, statistical data analysis. Not all of these aspects are of direct interest for the chemometrician. In this chapter we will cover a few topics in the analysis of sensory data. General introductory books are e.g. Refs. [1-3]. 

Ensure that the analytical methodology gives reliable results in terms of identity (absence of false-positive findings) and of absence (no false-negative findings) of the analyte(s). This requires processing of concurrent analytical quality control samples. 

The establishment of performance criteria for a given tumor marker test is not a simple process because accuracy and precision are unique for each type of analyte and its application. Establishing methodological limits for accuracy, precision, sensitivity, and specificity often requires standard reference materials, quality control materials, comparative studies, and actual clinical specimens. Accuracy and precision must be measured over the analyte reportable range for which the device is intended to be used. Sensitivity and specificity must be considered with respect to the intended clinical use of the device. Also, the indications for use should be carefully considered in the design of the study protocol. The indications for class II should be to monitor residual tumor after surgery (or radiation), the recurrence of tumor, or response to therapy. A 510(k) must provide clear evidence that the device is accurate, safe, effective, and substantially equivalent to a device legally marketed in the United States. 

Methodology and quality control Note methods audited... 

Therefore, the development and validation of a scientifically sound dissolution method requires the selection of key method parameters that provide accurate, reproducible data that are appropriate for the intended application of the methodology. It is important to note that while more extensive dissolution methodologies may be required for bioequivalency evaluations or biowaivers (i.e., multiple media, more complex dissolution media additives, and multiple sampling time points), it is also essential for the simplified, routine quality control dissolution method to discriminate batch-to-batch differences that might affect the product s in vivo performance. 

The application of appropriate Quality Control (QC) procedures or criteria is a mandatory consideration in the deployment and analysis of SPMDs (e.g.. Petty et al., 2000a). Similar to any performance-based methodology or approach. 

Shmeeda H, Even-Chen S, Honen R, Cohen R, Weintraub C, Barenholz Y. Enzymatic assays for quality control and pharmacokinetics of liposome formulations comparison with nonenzymatic conventional methodologies. Methods... 

The strict regulations of the pharmaceutical industry have a significant effect on the quality control of final products, demanding the use of reliable and fast analytical methods. The capacity that the technique has for the simultaneous determination of several APIs with no need of, or with minimum, sample preparation has considerably increased its application in pharmaceutical analytical control. The main limitation of NIR is the relatively low sensitivity that limits the determination of APIs in preparations when their concentration is less than 0.1%. Nevertheless, instrumental improvements allow the determination below this limit depending on the nature of the analyte and the matrix, with comparable errors to the ones obtained with other instrumental techniques. The reference list presents an ample variety of analytical methodologies, types of samples, nature of analyte and calibration models. A detailed treatment of each one is beyond the scope of... 

In pharmaceutical technology, quality assurance of the pharmaceutical formulation is important. When a pharmaceutical formulation is produced, on-line quality monitoring and control has to be performed in order to check the quality of the outgoing products. Methodology to perform this task is Statistical Process Control (SPC) and is not included in this book. Good text books in the area of SPC exists [6-9]. In this book the focus is on off-line quality control, e.g. how to make products that are intrinsic robust against process variations. 

Cornell J.A., How to Apply Response Surface Methodology. Basic References in Quality Control Statistical Techniques, Vol. 8. Milwaukee American Society for Quality Control, 1985. 

HPLC is a complex analytical methodology that involves the development of a unique method for each new application. This method development often requires the optimisation of several method conditions to achieve a desired selectivity and sensitivity [12,13]. HPLC is also one of the most commonly applied analytical techniques and is in widespread use throughout the pharmaceutical industry for applications as diverse as quality control, stability studies and clinical trials. These two reasons mean that HPLC has been the focus of most research into ruggedness testing procedures because it is most likely to require extensive ruggedness... 

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