Accreditation and Quality Assurance最新文献

The analysis of bromate is of particular interest for the assessment of water and food quality due to its toxicity. Analytical instruments such as ion chromatography have been used to measure bromate and require standard solutions for instrument calibration. A measurement method for potassium bromate as the source material of the standard solution has already been established. This paper describes the certification and long-term stability monitoring of bromate ion standard solutions with comprehensive uncertainty evaluations. The stability of potassium iodate is also presented as additional information.

Most of the papers that treat the composition of essential oils for this purpose use GC/MS or GC/MS and GC/FID techniques for the identification and/or quantification of individual compounds. Therewithal, papers usually treat the composition as semiquantitative (percentage composition as the area of the peak of a particular compound in relation to the total area of ​​the peaks on the chromatogram, given as 100 %). At the same time, the quality of the results is not treated in metrological terms. A GC/MS method for the quantification of components present Helichrysum italicum hydro-distilled essential oil samples from Bosnia and Herzegovina with a similar composition was developed and optimized. The stability of the method setup and adequacy of sample storage and manipulation were assessed. Calibration method and assessment of measurement uncertainty were established for neryl acetate, one of the major compounds with known health benefits.

In this study, analytical method validation has been done for the measurement of carbon dioxide/nitrogen (CO₂/N₂) and methane/nitrogen (CH₄/N₂) calibration gas mixtures using gas chromatography with flame ionization detector (GC-FID). Class-I calibration gas mixtures (CGMs) of CO₂ (500 µmol mol⁻¹ to 1100 µmol mol⁻¹) and CH₄ (2 µmol mol⁻¹ to 130 µmol mol⁻¹) used in method validation process has been prepared gravimetrically following ISO 6142-1. All prepared gas mixtures have expanded uncertainty 1 % at coverage factor (k) of 2 with 95 % confidence. The following parameters are chosen for this case study which include selectivity, accuracy, precision, linearity, limit of detection (LOD), limit of quantification (LOQ), robustness, stability, and uncertainty. Different statistical approaches are taken into consideration for each parameter assessment. The results indicate that GC-FID is selective for CO₂ and CH₄. CGMs represent good repeatability and reproducibility having percentage relative deviation < 1 % among measurements. A good linear behaviour was observed for CGMs of CH₄ and CO₂ on basis of least square regression with R² value 0.9995 and 1, respectively. LOD and LOQ for CH₄ are calculated 0.47 and 1.59 µmol mol⁻¹ based on signal-to-noise ratio by taking its lowest concentration of 2.9 µmol mol⁻¹. The in-house validated method for GC-FID using CGMs for the measurement of greenhouse gases (CO₂ and CH₄) is found to be precise, accurate and fit for purpose.

Nuclear magnetic resonance (NMR) has fast emerged as a quantitative platform for it offered numerous advantages over chromatographic methods in analyzing purity and determining content of organic compounds. However, the mechanism of parameter settings has not been further investigated causing the improper or incorrect use in the widespread qNMR applications. This study aims to construct a quantitative ¹H NMR methodology based on the experiment optimization and simulation and explain the impact of parameter settings on accuracy. We successfully applied the proposed ¹H qNMR method with the internal standard method to assess the purity of ofloxacin, a commonly used antibacterial drug. The study showed that parameter settings, including flip angle, relaxation delay, transmitter frequency offset, scan number and data point, had different effects on the quantification errors (0.5 % to 8.9 %). The method validation proved that the ¹H qNMR methodology delivered high accuracy with the measurement uncertainty (0.60 %). The results demonstrated that the proposed ¹H qNMR method provided clear guidance on the practical implementation of accurate quantification of low molecular mass compounds (< 500 g/mol).

To analyze and statistically compare common errors in the evaluation of measurement uncertainty in medicine and health field, using literature research and comparison with national standards, in order to understand the current status of measurement uncertainty evaluation in the medicine and health field. Using Chinese National Knowledge Infrastructure (CNKI) as the sample population, Stratified Proportional Sampling (PPS) was used to extract journal articles related to measurement uncertainty in the field of medicine and health. The articles were compared with the Eurachem/CITAC Guide QUAM to analyze measurement uncertainty errors. Academic attention to measurement uncertainty in the field of medicine and health in the CNKI literature database has shown explosive growth since 2005. Seven common errors in measurement uncertainty evaluation were identified. None of the 30 journal articles analyzed were error-free, with a total error rate of 44 %. The error rate for ignorance of blank uncertainty was 87 %, improper evaluation of standard curve was 67 %, improper significant figures were 60 %, and insufficient information for Type B evaluation was 50 %. The error rate for provincial and higher-level institutions was 48 %, while the error rate for institutions below the provincial level was 43 %. The difference between the two error rates was not statistically significant (p = 0.523). There is an urgent need to improve the rationality of measurement uncertainty evaluation in medicine and health field, and to strengthen the education and academic communication through national and international cooperation.

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The biotechnology policy encourages the creation of networks of institutions that carry out bioassays and preclinical studies and stimulate the implementation of principles of good laboratory practice (GLP). However, it becomes essential for trained and qualified professionals to understand, develop procedures and documents, and properly implement quality management requirements to implement a laboratory quality system. The use of tools such as multicriteria decision aid (MCDA) can assist in managing and implementing the quality system in institutions and laboratories. This research aimed to demonstrate the perception of the degree of difficulty in understanding GLP principles perceived by the respondents and analyzed through the MCDA model. According to the MCDA method, a survey was carried out with 27 professionals from laboratories who answered a questionnaire with a numerical scale of very difficult, difficult, regular, neutral, and easy for each GLP requirement. Results evidenced the GLP criteria that require a smaller and greater effort to be understood and allowed the identification of efforts level to increase each GLP criteria's level of understanding. The MCDA confirms to be a robust tool to identify and validate the participants' perception of GLP criteria, considering the diversity of professionals and their different qualifications, enabling the construction of training content that considers the difficulty levels of each criterion. This strategy helps in the management of the laboratory and the dissemination of knowledge of GLP principles to biotechnology professionals, academics, and students.

The assessment of homogeneity of liquids in storage tanks is crucial for quality control products, commercial relations and a salient technological challenge facing the petroleum industry. This study describes a method used in the Brazilian oil industry to estimate if there is significant (vertical) segregation in large storage tanks. Here, a method based on experimental design and classical ANOVA for analyzing the experimental data to arrive at a better method to estimate if there is statistically significant segregation within the storage tanks (lack of significance is called homogeneity in the paper) was used. Although ANOVA is a suitable tool for this purpose, the results were analyzed in more detail to propose a practical method that can be used routinely. Mechanical use of the ANOVA tests may easily lead to wrong conclusions.

The purpose of this study was to study the impact of ISO 9001 on the main factors of the sustained success of companies. A background theoretical study was conducted on sustained success factors and the impacts of ISO 9001 implementation on companies’ performance. Then, the impacts of ISO 9001 on industrial companies in Turkey were identified and validated through questionnaires and interviews. The study revealed that all the SSFs were positively influenced by ISO 9001. Despite the contradictions in the literature, the study shows ISO 9001 has a positive effect on the innovative ability of these companies and a clear positive effect on adopting spiritual values. But ISO 9001 does not support a shift toward a less bureaucratic culture. This study was limited by the difficulty of distinguishing the findings based on the sectors and sizes of the companies. Although the findings could cover all areas, this research was only conducted in industrial companies based in Turkey. At the time of undertaking the current study, there are no empirical studies on the effect of ISO 9001 on the SSFs; in this study, the effect of ISO 9001 implementation on these factors was practically validated.

L-lysine is an essential amino acid that contains a hydrophobic chain and fewer chromophore groups. Various L-lysine-based products are currently available in the market, and various analytical methods are reported in the literature; but their implementation to analyze L-lysine based products is highly cost-effective and requires considerable efforts to prepare the sample/derivatization. Currently, the developed method is being used to quantify L-lysine hydrochloride in the multivitamin oral suspension production in the pharmaceutical industry. Therefore, the aim of the work was to develop a novel, simple, sensitive, accurate, cost-effective, precise, and robust RP-HPLC-DAD method to quantify L-lysine hydrochloride in bulk drug substances and multivitamin oral suspension using C8 column, which may give more efficiency for amino acid analysis without any derivatization. Optimized mobile phase composition consists of solvent A (phosphate buffer: acetonitrile 95:5 v/v) and solvent B (Phosphate buffer: acetonitrile 5:95 v/v). Buffer pH was adjusted to 2.50 with 3 mol L⁻¹ Orthophosphoric acid. 1-Heptane sulphonic acid anhydrous sodium salt was used as an ion-pairing reagent in the buffer. The detector's wavelength was set at 208 nm with a mobile phase flow rate of 1 mL/minute. Limit of detection (({L}_{mathrm{D}})) and limit of quantification (({L}_{mathrm{Q}})) were found to be 17.80 g/mL and 53.94 g/mL, respectively. Excellent recovery was observed in the accuracy analysis of the sample L-lysine hydrochloride. The advantages of this newly developed method are very specific and cost-effective and do not require sample preparation and sample pretreatment. This analysis can be performed with an available C8 column and HPLC–UV detector that proves the cost-effectiveness of the developed method than the currently available analytical methods for the analysis of L-lysine based products.