Quality control issues

When receiving natural colour products from the supplier it is normal to carry out a quality control. The extent of this control will typically depend on the type of colour product, the iirformation available on the certificate of analysis, the expected processing conditions, the finished product and the standard quality control procedures of the food or beverage manufacturer. In some cases the colour strength or colour hue and intensity may be the most relevant parameter. In others the microbiological standard and absence of pathogens is also important. For powder formulations to be used in dry blends, the particle size is 

---

E. The degree of occlusion (in fact, the tightness of the wrap over the test site) also alters percutaneous absorption and therefore irritation. One important quality control issue in the laboratory is achieving a reproducible degree of occlusion in dermal wrappings. 

While ISO 9000 is a management tool, it affects the way industry does business and deals with quality control issues such as how machinery and parts manufactured by a company are monitored for quality. It focuses on satisfying the customer, the purchaser of the raw materials, manufactured parts, or assembled items, and includes the eventual end-customer —the general public. It is an attempt to assure quality goods. 

As with any analytical determination procedure, both quality assurance and quality control issues have to be built into the detection of PPCPs in the environment. For example, analysis of polycyclic musks (PCM) can be easily skewed during analysis as the compound might be present in laboratory soaps and creams, thus coating laboratory glassware used for the analysis. Therefore, programs that are designed to research... 

Sometimes a company may make a certain amount of a drug for clinical trials. Then when they go to scale up, they may lose a supplier or end up with quality control issues that result in a product of different chemistry, says the FDA s Kweder. Sponsors have to show us that the product that s going to be marketed is the same product that they tested. ... 

Michael J. Groves, a pharmacist with a doctorate in chemical engineering, has spent much of his career working in industry and academe. Now retired, his scientific interests include dispersed drug delivery systems and quality control issues for parenteral drug products. Editor or joint editor of a number of books, he has published 400 research papers, patents, reviews, and book reviews. He is a Fellow of the Royal Pharmaceutical Society of Great Britain, the Institute of Biology, and the American Association of Pharmaceutical Scientists. 

Despite all the attractive advantages of complexation, there are several disadvantages. First, the compound has to be able to form complexes with a selected ligand. For compounds with very limited solubility to start with, the solubility enhancement can be very limited. Second limitation is that for the complexes oAp type, dilution of a system may still result in precipitation. This is also true for solubilization through combined techniques such as complexation with pH adjustment. Third, the potential toxicity issue, regulatory, and quality control issues related to the presence of the ligand may add to complication and cost of the development process. Finally, the complexation efLciency is often rather low, thus relatively large amount of CDs are typically required to achieve desirable solubilization effect (Loftsson et al., 1999). 

In addition to the binding constant and safety considerations, economics, and quality control issues also play a role in considering which ligands to use. Because of the difLculty in selectively derivatizing a speciLc hydroxyl or family of hydroxyls, most modiLed CDs of pharmaceutical interest are likely to be complex mixtures (Stella and Rajewski, 1997). Methods to characterize these mixtures, therefore, need to be in place to assure lot-to-lot reproducibility. The costs of acute and chronic safety studies required to evaluate any new CD derivatives are very high, and this prohibits them from being widely evaluated for pharmaceutical applications. 

R. A. Baffi and R. L. Gamick, Quality control issues in the analysis of lyophilized proteins, Dev. Biol. Stand. 181 -184 ( 1991). 

Barkat, Mohammed. Quality assurance/quality control issues in gmp regulatory compliance. Drug Inf. J. 1997, 31, 765-769. Oracle clinical corp. In Oracle Clinical User Reference, Oracle Clinical Corp. Redwood Shores, CA 1-10. 

As an important parameter for surface quality, roughness is discussed in almost every article on cleaning and etching. However, in most cases it is treated as a quality control issue. As a result, the data on surface roughness reported in the literature for silicon surfaces are obtained under diverse conditions and are generally not comparable due to the fact that data are often reported without clear definition of the methods of determination and the area of sampling. 

Broad reviews of aerosol packaging and production may be found in the literature [4-9]. The following sections focus specifically on the process of placing the components of the aerosol formulation into a sealed container. Thus, it is beyond the scope of this chapter to consider the physicochemical aspects to the development of the formulation itself, the selection of actuators for the value or any other packaging materials (labels, boxes, and package inserts), or subsequent quality control issues. 

The focus of this chapter is on quality assurance and quality control issues facing clinical laboratories, with emphasis on chromatographic analysis. Chromatography is a versatile analytical technique with diverse applications including gas chromatography (GC), liquid chromatography (LC), GC or LC coupled with mass spectrometry (MS) and other qualitative and quantitative bioanalytical methods. 

As part of a laboratory s quality control program, all steps of the test should be described separately, and parameters of each step established and monitored in order to ensure consistency of performance and reproducibility of results. Daily records of control results are maintained, and corrective actions are undertaken and documented when results are unacceptable. In practice the surgical pathology histology laboratory typically falls short of the ideal standards in key areas, especially with regard to tissue preparation. In this section, we will discuss quality control issues as they pertain to the validation of antibodies and the use of controls. We will also address measures that may be adopted to minimize variability deriving from inconsistent tissue preparation, including fixation. 

There are samples or crude extracts containing the analyte of interest but whose concentration has not been accurately established. For marine biotoxins, such materials may be frozen homogenates of naturally contaminated seafood, crude or partially purified extracts of such seafood, or of harmful algae. Digestive glands of contaminated shellfish are a source of concentrated toxins and their metabolites. Such materials cannot be used to calibrate methods of analysis but can serve very useful functions in method validation and quality control, especially when they contain rare toxins not readily available elsewhere (i) Retention times and spectral properties can be established on a routine basis for LC-UV, LC-FL, or LC-MS methods (ii) Partially purified extracts can be used for fortification experiments during method validation and thus establish recovery and precision data (iii) If concentrations of toxins can be established by reference to CRMs, then the materials can be used as in-house or interlaboratory reference materials for quality control. Issues such as toxin stability and homogeneity then become more important. ... 

As speciation methodology has developed over the past 40 years, it has become clear that quality control issues such as sampling, sample preparation, and calibration are critical to obtain meaningful results regarding environmental samples. Many early studies were flawed by errors in these methodologies that produced inaccurate data. Here some of the major issues in sample handing and treatment are discussed. 

The debate over techniques (1) and (2) initially centered on the main component of the analytical technique (i.e., wet-UV or dry-high temperature ) but it has become apparent that the most significant difficulties with this measurement are more to do with analytical quality control issues such as the use of appropriate blanks, strict control of day-to-day operating conditions, and great care in calibration procedures. A very recent report by Sharp and coworkers on an extensive intercalibration exercise states that Experienced oceanic analysts, with internal or shared reference materials, can now show reproducibility and comparability at a level closer to 2% . The development of DOC reference materials is in its early stages and once such materials are reliably available then the DOC issue should settle down as a difficult but essentially routine measurement. 

In developing a microsphere formulation for proteins, it is important to consider the regulatory requirements for the approval of an Investigational New Drug (IND) application by the US. FDA. These requirements include toxicology testing, manufacturing reviews, quality assurance and quality control issues, and preclinical studies. 

Quality Control Issues in Polymeric Nanopartlele Systems... 

Address various quality control issues and as a total quality management (TQM) tool... 

---