1,720,954 research outputs found
Cross-contamination Risk Assessment using FMEA tool
Get PDFIn pharmaceutical manufacturing facilities, products with different therapeutic properties and potencies are manufactured in shared spaces, which poses a potential risk for cross-contamination. During the manufacturing process, cross-contamination may occur due to the uncontrolled release of dust, gases/vapors, mix-ups with other materials, residues on equipment, and contamination from operator’s clothing. By implementing adequate facility design and manufacturing operations aligned with Quality Risk Management principles, the risk of cross-contamination can be controlled. If a shared facility is used for manufacturing pharmaceutical products, strategic controls for identifying and managing the risks of cross-contamination should be in place. This article provides a structured and systematic framework for the risk-based identification of the worst-case product and manufacturing process among the products manufactured in the solid oral facility, addressing the high risk of cross-contamination.
Keywords: Cross-contamination, Contamination, Risk Assessment, Formal risk assessment, Quality Risk Management (QRM), Failure Mode Effect Analysis (FMEA), Oral Solid Dosage (OSD), Worst case, Contamination Control Strategies (CCS
Quality Risk Management: Degree of formality, Formal and Informal QRM
No full textThe International Council for Harmonization’s (ICH) Q9 (R1): Quality Risk Management (QRM) guideline made effective from May, 2023. ICH Q9’s revision provides guidance on QRM for the pharmaceutical industry and regulatory environment. It aims to improve decision-making by offering a systematic approach that complements existing quality practices and guidelines. The document emphasizes that understanding formality in quality risk management can optimize resource usage and support risk-based decision-making by reflecting the level of importance, uncertainty, and complexity of the decision.5 QRM is the process of appropriately managing risks to product quality throughout the product\u27s life cycle in order to optimize its benefit–risk balance. It is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk. The overall approach for determining how much formality to apply during QRM activities should be described within the quality system. In addition, subjectivity can directly affect the effectiveness of risk management activities and the decisions made. Therefore, it is important that subjectivity is managed and minimized.1,6
Keywords: Quality Risk Management (QRM), Degree of Formality, Uncertainty, Importance, Complexity, Formal risk assessment, Informal risk assessment, QRM Techniques, QRM Tools, IC
Going Beyond Counting First Authors in Author Co-citation Analysis
Get PDFThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Get PDF“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Get PDFWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
Dispelling the Myths Behind First-author Citation Counts
Get PDFWe conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued
use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation
counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more
sophisticated methods
koamabayili/VECTRON-author-checklist: VECTRON author checklist
No full textWe have done our best to complete the author checklist relating to the use of animals in the hut study. Note that the objective for the hut study was to evaluate the IRS treatment applications for residual efficacy against Anopheles mosquitoes, including the local An. coluzzii mosquito population. Cows were only used to attract mosquitoes into the huts and no tests were carried out directly on the cows. The author checklist is intended for use with studies where experiments are carried out on animals, which is why we have had such difficulty in completing this for the hut study, as many of the questions do not relate to how the cows were used
Author-wise bibliometric analysis based on entropy.
No full textAuthor-wise bibliometric analysis based on entropy.</p
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