Accreditation and Quality Assurance最新文献

{"title":"The level of peripheral blood β-hCG concentration is inconsistent with the clinical manifestations of pregnant women: a cautionary tale","authors":"Guangjun Xiao,&nbsp;Juan Hu,&nbsp;Yanting Liu,&nbsp;Yutao Wang,&nbsp;Huanhuan Wang,&nbsp;Shaocheng Zhang","doi":"10.1007/s00769-025-01639-9","DOIUrl":"10.1007/s00769-025-01639-9","url":null,"abstract":"<div><p>As of September 2024, 964 clinical laboratories in China have achieved ISO 15189 accreditation, demonstrating their adherence to internationally recognized standards in quality, technology, and management. However, in one such ISO 15189-accredited laboratories, discrepancies arose between <i>β</i>-human chorionic gonadotropin (<i>β</i>-hCG) test results and the clinical manifestations of pregnant women, following a change in the reagent batch number. An investigation revealed that although the laboratory had established internal quality control (IQC) procedures and performance verification protocols for reagents and consumables for <i>β</i>-hCG testing, and monitored the ongoing validity of test results according to established standards, the IQC sample concentrations of the IQC sample did not encompass the ‘threshold’ required for the automated dilution detection of the testing system, the IQC procedure could not effectively assess the accuracy of high-concentration <i>β</i>-hCG samples, failing to detect whether the automated dilution procedure was functioning correctly. More concerningly, after the <i>β</i>-hCG test results for high-concentration specimens in the laboratory falsely decreased, laboratory personnel failed to promptly recognize the inconsistency between the test results and the clinical manifestations of the pregnant women. This issue was only recognized after 4 days, when it was raised by the requesting doctor. Therefore, we present this case to as a cautionary example for quality management in other clinical laboratories. Laboratories should focus on the quality risks associated with the automated dilution procedure in testing systems and are advised to monitor system performance by retesting patient samples and developing IQC materials.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 4","pages":"465 - 471"},"PeriodicalIF":1.0,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145168623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A critique to “Target uncertainty: a critical review”","authors":"Adriaan M. H. van der Veen","doi":"10.1007/s00769-025-01636-y","DOIUrl":"10.1007/s00769-025-01636-y","url":null,"abstract":"","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 4","pages":"485 - 486"},"PeriodicalIF":1.0,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145168011","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Combined analytical, eco-friendly, and validated stability indicating method development of tavaborole with the study of its degradants via LC–MS","authors":"Komal Kangne,&nbsp;Mayuri Pandit,&nbsp;Atul Shirkhedkar,&nbsp;Shweta Gunjal,&nbsp;Vilas J. Pise,&nbsp;Akhil Nagar","doi":"10.1007/s00769-025-01635-z","DOIUrl":"10.1007/s00769-025-01635-z","url":null,"abstract":"<div><p>Tavaborole (TVB), a benzoboroxole derivative, was approved for treating onychomycosis. Boron’s unique properties, such as variable oxidation states, and stability, require specialized analytical methods. The current RP-HPLC method was developed using eco-friendly solvents, maintaining pH, and providing a sharp peak at 5.7 min at 272 nm. A new NP-HPTLC technique was established employing a mobile phase composed of toluene and methanol, yielding an <i>R</i>_<i>f</i> value of 0.58 with a similar correlation coefficient of 0.9989 for both methods. The accuracy of TVB for both methods was evaluated at levels of 80 to 120%, providing the %RSD in the range of 0.42 to 0.86% (for HPLC) and 0.95 to 1.50% (for HPTLC). The reproducibility for the two methods was performed in triplicate (30–50 µg/ml) for HPLC and (4000 to 6000 ng/band) for HPTLC, and %RSD was evaluated. Replicates at 20 μg/ml for HPLC and 5000 ng/band for HPLTC show the %RSD of 1.42 and 0.65, respectively. Robustness parameters were evaluated by altering pH, wavelength, and flow rate for HPLC and mobile phase composition, plate saturation time, and development distance for HPTLC. The robustness was evaluated by altering the analyst to calculate a %RSD of 0.88 and 0.31 for HPLC and 0.12 and 0.22 for HPTLC. From the results, all the validation parameters are found within acceptable ranges. TVB showed stability in acidic and basic conditions, with degradation observed only under peroxide treatment. An attempt will be made to identify the probable and major degradants of TVB using LC–MS spectra, which was crucial considering the boron’s chemical properties. The RP-HPLC method was confirmed as environmentally sustainable using the AGREE program metrics. In contrast, the NP-HPTLC method met validation standards but was not considered eco-friendly due to solvent choice. Both methods are suitable for commercial applications.</p><h3>Graphical abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 3","pages":"261 - 275"},"PeriodicalIF":1.0,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145144620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Compendial testing of antiretroviral drug reference standards for metrologic traceability: Bictegravir and cabotegravir","authors":"Troy D. Wood,&nbsp;Richard W. Browne,&nbsp;Erin R. Tiede,&nbsp;Connor E. Gould,&nbsp;Diala Ghazal,&nbsp;Robin DiFrancesco,&nbsp;Gene D. Morse","doi":"10.1007/s00769-025-01634-0","DOIUrl":"10.1007/s00769-025-01634-0","url":null,"abstract":"<div><p>ISO/IEC 17043:2015 specifies general requirements for the competence of providers and development and operation of proficiency testing schemes. As a requirement of ISO/IEC 17043:2015 accreditation, the Clinical Pharmacology Quality Assurance (CPQA) program uses ISO 17034 certified reference materials (CRMs) to produce proficiency testing materials in antiretroviral drug panels. CRMs that meet the ISO/IEC 17034 standard can be prohibitively expensive for CPQA participating laboratories (CPLs), requiring authentication of purity and identity by compendial testing. Here, to assist CPLs, we report on a compendial testing approach used to assess whether standard reference materials for bictegravir and cabotegravir, two commonly prescribed drugs used in combination regimens in the treatment of HIV-1 infection, for proficiency testing. Our approach uses high-performance liquid chromatography and thermogravimetric analysis to evaluate purity of the materials, and the combination of high-resolution mass spectrometry and proton nuclear magnetic resonance spectroscopy to establish molecular identity. Using this workflow, we identified standard reference materials for bictegravir and cabotegravir that are economical alternatives for CPLs.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 3","pages":"291 - 303"},"PeriodicalIF":1.0,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145142519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of simultaneous equation method for the estimation of andrographolide and apocynin in hepatoprotective polyherbal formulation using UV–visible spectrophotometry","authors":"Shweta Mevada,&nbsp;Harsha Patel,&nbsp;Saurabh Shukla","doi":"10.1007/s00769-025-01633-1","DOIUrl":"10.1007/s00769-025-01633-1","url":null,"abstract":"<div><p>The aim of this study was to develop a simple, accurate, and precise UV–Vis spectrophotometric method for the simultaneous determination of Andrographolide and Apocynin, bioactive compounds derived from <i>Andrographis paniculata</i> and <i>Picrorhiza kurroa</i>, respectively. These compounds are known for their hepatoprotective and antioxidant properties, and accurate quantification is essential for quality control of herbal formulations. A simultaneous equation method was developed based on the additive absorbances of Andrographolide and Apocynin at their respective λmax values (224 nm for Andrographolide and 274 nm for Apocynin). Linearity was established over a concentration range of 0.5 to 2.5 µg/mL for both compounds. Validation was conducted for parameters such as limits of detection (LOD), limits of quantification (LOQ), precision, and recovery. The method was applied to the analysis of three marketed herbal formulations. The method exhibited excellent linearity with correlation coefficients of 0.999 for Andrographolide and 0.998 for Apocynin. LODs were 0.012 µg/mL for Andrographolide and 0.066 µg/mL for Apocynin, with LOQs of 0.039 µg/mL and 0.202 µg/mL, respectively. Precision, confirmed by relative standard deviation (RSD) values below 2%, and recovery studies (98.66 %–102 % for Andrographolide, 98 %–101.60 % for Apocynin) demonstrated the method’s accuracy. The method successfully quantified the compounds in marketed herbal formulations, with results consistent with the label claims. The UV–Vis spectrophotometric method offers a reliable, precise, and cost-effective approach for the simultaneous quantification of Andrographolide and Apocynin in herbal formulations. Its simplicity and efficiency make it suitable for routine quality control in the pharmaceutical industry.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 3","pages":"253 - 260"},"PeriodicalIF":1.0,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145144453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"On the role of probability in science, analytical measurement and QUAM","authors":"R. Willink","doi":"10.1007/s00769-025-01631-3","DOIUrl":"10.1007/s00769-025-01631-3","url":null,"abstract":"<div><p>Recently, it has been shown that a probability distribution attributed to a constant, e.g. the true concentration of an analyte, cannot be used to accurately describe an objective set of information about the constant (Measurement Sensors 24, 2022, 100416;  Accreditation and Quality Assurance 29, 2024, 189–192). In this paper, that result is extended to show that such a distribution cannot always accurately describe subjective belief about it either. These results suggest that a logical system of uncertainty analysis in measurement can only be based on classical principles in which probability distributions describe patterns of measurements and errors under repetition. They call into question the premise underlying the approach to the evaluation of measurement uncertainty promoted in the supplements to the <i>Guide to the Expression of Uncertainty in Measurement</i>. The relevance of these results to the Eurachem/CITAC Guide <i>Quantifying Uncertainty in Analytical Measurement</i> (QUAM) is discussed, and QUAM is shown to be largely free of the problematic idea.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 3","pages":"245 - 252"},"PeriodicalIF":1.0,"publicationDate":"2025-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s00769-025-01631-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145144705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"RP-HPLC-based simultaneous quantification and stability assessment of doxycycline hyclate and aloe-emodin in lipid nanocarriers","authors":"Muzammil Husain,&nbsp;Yogeeta O. Agrawal","doi":"10.1007/s00769-025-01632-2","DOIUrl":"10.1007/s00769-025-01632-2","url":null,"abstract":"<div><p>A novel simultaneous estimation and stability-indicating RP-HPLC method was developed and validated for the simultaneous quantification of doxycycline hyclate and aloe-emodin in blend and in novel nanostructured lipid carriers. The mobile phase comprised a phosphate buffer to methanol at ratios of 40:60 (v/v) and 70:30 (v/v), both at pH 8, for the separation of doxycycline hyclate and aloe-emodin, respectively. Detection was performed using a PDA-M20A photodiode array detector at a lambda of 268 nm (doxycycline hyclate) and 250 nm (aloe-emodin). The method was validated according to the instructions of ICH guidelines for precision, accuracy, linearity, specificity, limit of detection, and limit of quantitation. The developed method exhibited linearity in the concentration range of 5–30 µg/mL for both analytes. The limit of detection and limit of quantitation were estimated to be 0.0279 µg/mL and 0.0846 µg/mL for doxycycline hyclate and 0.0262 µg/mL and 0.0795 µg/mL for aloe-emodin, respectively. Accuracy, as estimated by percent recovery, ranged from 180.37% to 216.52% for doxycycline hyclate and from 180.17% to 214.59% for aloe-emodin, depicting high recovery values. Forced degradation studies under five distinct stress conditions depict the competency of the method. The present study explored the simultaneous measurement of aloe-emodin and doxycycline hyclate in the novel nanostructured lipid carriers based gel. The technique demonstrated excellent specificity, accuracy, and sensitivity, with distinct retention times and well-defined peaks for each drug and its degradation products.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 3","pages":"233 - 244"},"PeriodicalIF":1.0,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145143937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Investigation of internal standard use for short-term drift correction in ICP-MS/MS","authors":"Emma C. Braysher,&nbsp;Richard J. C. Brown,&nbsp;Andrew S. Brown","doi":"10.1007/s00769-025-01630-4","DOIUrl":"10.1007/s00769-025-01630-4","url":null,"abstract":"<div><p>Noise in the signal of mass spectrometers is often corrected by an internal standard. This study investigates the effectiveness of internal standard application to environmental samples, namely, inductively coupled plasma-mass spectrometry analysis of particulate matter samples from the UK Heavy Metals Air Quality Monitoring Network at NPL. This Practitioner’s Report describes an investigation that has demonstrated potential drawbacks of internal standardisation using the set-up described, including bias in measured composition, which was found to contribute between 1.3–2.6%. Retrospective estimation of internal analyte content in particulate matter sample was carried out and found to be in good agreement with the literature (Y: 1 pg/m³, Sc: 5 pg/m³, In: 10 pg/m³, Bi: 50 pg/m³). Improvement of the signal to noise ratio is assessed and found to be minimal in the set-up investigated. It is concluded that for this application, introduction of an internal standard for high frequency noise correction gives minimal benefit and can even introduce measurement bias. These findings should be considered the next time the EN 14902 standard is revised.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 2","pages":"221 - 231"},"PeriodicalIF":0.8,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143602404","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of ISO 9001:2015: quality management system in the university by a verification method","authors":"Mahmoud Fadhel Idan","doi":"10.1007/s00769-024-01629-3","DOIUrl":"10.1007/s00769-024-01629-3","url":null,"abstract":"<div><p>This study aims to present new scientific methods to assess the extent of universities’ commitment to the international standard and to assess the quality level of university units according to the International Quality Management Standard 2015, in addition to applying the current internal audit. These scientific methods included calculating the arithmetic mean and standard deviation and drawing a control panel to determine the extent of commitment to the specification at the beginning and after qualification. Statistical values were calculated, including the arithmetic mean and standard deviation for each paragraph of the international specification after analyzing the questionnaire responses from volunteer students and professors. These forms included two models: the first of which included all paragraphs of the specification and the second was written differently to determine the accuracy and seriousness of the participants in the questionnaire. The standard deviation was 0.0 in most paragraphs of the specification, which means there was no dispersion in the selection of participants, indicating the success of the qualification process and increased awareness and interest in applying the specification among all concerned parties. The degree of importance of these paragraphs reached 5, and this was confirmed by aligning the upper and lower control lines with the average line, which is consistent with the internal audit reports, this proves the accuracy and credibility of this method in the evaluation process.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 2","pages":"183 - 193"},"PeriodicalIF":0.8,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143602170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Toward ISO/IEC 17025 compliance: challenges and strategies for a university research laboratory","authors":"H. Bennari,&nbsp;S. El Omari,&nbsp;A. Habsaoui,&nbsp;H. Chaair,&nbsp;S. Belouafa","doi":"10.1007/s00769-024-01628-4","DOIUrl":"10.1007/s00769-024-01628-4","url":null,"abstract":"<div><p>This study assesses the compliance of a university research laboratory with the ISO/IEC 17025: 2017 standard, focusing on ensuring technical competence and the integrity of analytical results. An analytical approach was employed using a standard checklist to identify gaps and establish a corrective action plan. The evaluation revealed significant deficiencies in the laboratory's structural, resource, and process requirements, resulting in an overall satisfaction rate of only 15%. This percentage reflects the proportion of conformity criteria met by the laboratory in relation to the standard’s requirements. These findings underscore the critical need for improvements in the laboratory’s quality management system to enhance the reliability and credibility of its research outputs. The study also emphasizes the importance of implementing robust quality control measures and continuous staff training to meet international standards, thus positioning the laboratory to achieve full ISO/IEC 17025 compliance in the future.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"30 1","pages":"55 - 66"},"PeriodicalIF":0.8,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142995077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}