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21.
22.
Ilya?KuselmanEmail author Alexander?Weisman Wolfhard?Wegscheider 《Accreditation and quality assurance》2003,8(11):530-531
The current situation in the pharmaceutical industry is discussed, when the traceability of measurement (analytical) results to certified values of pharmacopoeial reference standards is required, without evaluating their uncertainties. It is shown that the evaluation of measurement uncertainty is necessary for understanding the level of confidence of the analytical results and their comparability, particularly during preparation and characterisation of the reference standards.Papers published in this section do not necessarily reflect the opinion of the Editors, the Editorial Board and the Publisher. Apart from exceptional circumstances, they are not submitted to the usual referee procedure and go essentially unaltered. 相似文献
23.
Maria Francesca Alberghina Patrizia Capizzi Salvatore Schiavone Silvestro Antonio Ruffolo Valeria Comite 《Natural product research》2019,33(7):1034-1039
AbstractStructural analysis of marble statues, carried out by non-invasive and in situ methods, is crucial to define the state of conservation of the artworks and to identify the deterioration phenomena that can affect them. In this work, we combined in situ non-destructive techniques, ultrasonic tomography (US), ultraviolet-induced visible fluorescence (UV-IF) and X-ray fluorescence (XRF) to study the bass-relief ‘Madonna con Bambino’ (Gorizia, Italy). The US revealed the presence of some metallic pivots, associated with areas of high sound velocity; moreover, a more degraded area has been identified in the lower part of the bass-relief. The acquired UV-IF image confirmed the presence of surface degradation, allowing a preliminary evaluation of the extension of a fracture, from surface to bulk. In addition, the different materials (both original and/or integrations) that compose the studied surface have been identified. The XRF has contributed to define the nature of the inorganic materials applied during undocumented previous restoration works on the surface as filler for lacunae. 相似文献
24.
Solveig Linko 《Accreditation and quality assurance》2002,7(2):55-59
Internal audits inherently effect quality improvement, and concrete results can be expected by careful planning. As audits
should improve the quality system in situ, the development of audits should not be neglected. ISO/IEC 17025 describes the
objectives of internal audits and management reviews in more detail compared to the former standards EN 45001 and ISO/IEC
Guide 25, although the main features are unchanged. This addresses continuous surveillance of the current practice. A brief
questionnaire on vertical audits was distributed to 74 of 120 employees at a Finnish private medical laboratory, Medix Laboratories
Ltd. A positive feed-back was received from the current management of audits. However, the study revealed that continuous
supervision of audits is needed. Many employees were not willing to perform audits if they had no previous experience. Additionally,
audits performed at the workbench were not considered as the best possible for fruitful discussions.
Received: 20 February 2001 Accepted: 30 November 2001 相似文献
25.
26.
G. Maldener 《Chromatographia》1989,28(1-2):85-88
Summary One possible method has been demonstrated for pharmaceutical quality control which is not restricted to this field and fulfils and documents the prerequisites for reliable, accurate and precise HPLC analysis. This includes validation which shows that the method is able in principle to fulfil the requirements, the apparatus test which shows that the apparatus generally works correctly and precisely and the system suitability test which shows that the method provides accurate and precise results on this apparatus and with this column for the analysis in question when other non-equipment and non-method-induced errors are excluded. 相似文献
27.
Guidelines ISO 17025 and ISO 15189 aim to improve the quality-assurance scheme of laboratories. Reliable analytical results are of central importance due to the critical decisions that are taken with them. ISO 17025 and ISO 15189 therefore require that analytical methods be validated and that laboratories can routinely provide the measurement uncertainty of the results of measurements. To evaluate the fitness of purpose of analytical methods, total error is increasingly applied to assess the reliability of results generated by analytical methods. However, the ISO requirement to estimate measurement uncertainty seems opposed to the concept of total error, leading to delays in laboratories implementing ISO 17025 and ISO 15189 and confusion for the analysts. This article therefore aims to clarify the divergences between total error and measurement uncertainty, but also to discuss their main similarities and emphasize their implementation. 相似文献
28.
Reliable, traceable and comparable measurements provide the rational basis for evaluation of the quality of a result and
the starting point for recognized laboratory accreditation in any national area. Modern medical diagnostics and treatment
involve rapidly rising numbers and types of clinical laboratory measurements, that are reliable. Therefore, the basic principles
to be followed to assure the traceability of clinical measurements as required by the Romanian Laws of Metrology are reviewed.
Main sources affecting the quality of the unbroken chain of calibrations that relate the measurements back to appropriate
measurement standards are discussed. Examples of how to achieve traceable measurements in clinical laboratories are presented.
Details of specific uses of reference materials, measuring instruments and standard measurement methods are also discussed.
Received: 8 January 1998 · Accepted: 21 April 1998 相似文献
29.
This paper describes the validation of an isocratic HPLC method for the assay of voriconazole in tablets. The method employs
a Merck LiChrospher? 100 RP-8 (125 × 4.6 mm I.D., 5 μm particle size) column, with a mobile phase of methanol : triethylamine solutions 0.6 %,
pH 6.0 (50:50, v/v) and UV detection at 255 nm. A linear response (r > 0.9999) was observed in the range of 20.0–100.0 μg mL−1. The method showed good recoveries (average 100.4%) and the relative standard deviation intra and inter-day were ≤ 1.0 %.
Validation parameters as specificity and robustness were also determined. The method can be used for both quality control
assay of voriconazole in tablets and for stability studies as the method separates voriconazole from its degradation products
and tablet excipients. 相似文献
30.
In order to determine the quality of young Cognac spirits, mainly appreciated by the absence of defects, a new method has been developed, based on sniffing and olfactometry (GC-O) and associated with sensory and chemical analysis. During 3 years, good quality spirits selected first by Cognac merchant were analysed and selected by an original panel of tasters used to judge those spirits. The aromatic profile were established and compared. Then, the most different spirits were analysed by sniffing coupled with gas chromatography. The olfactometric profile obtained were compared. We noticed that they have all the same aromatic base constituted with 18 specific areas. Six of them were unknown and we are trying now to identify them. 相似文献