TransCelerate's Clinical Quality Management System: From a Vision to a Conceptual Framework.

The Quality Management System (QMS) initiative of TransCelerate BioPharma Inc has identified potential benefits that could be captured from the development of a flexible, proactive clinical QMS conceptual framework for clinical research. Such a framework would aid organizations in seamlessly managing the complex clinical trial environment and, ultimately, in expediting delivery of needed treatments to patients. This article chronicles the evolution of a TransCelerate concept paper describing a proposed clinical QMS framework and reviews feedback from varied global clinical trial stakeholders during socialization of the concept paper. Many stakeholders recognized the potential for the concept paper to inform development of a harmonized International Council for Harmonisation (ICH) guideline, providing needed clarity from regulators on their expectations for QMS in the clinical realm. Accordingly, the article also describes TransCelerate's efforts to work with regulators to facilitate harmonization on this important topic and reviews ongoing work to develop additional tools and resources that may support organizations in evaluating whether and how they might translate the conceptual framework principles into practice.

Análise microbiológica de misturas prontas destinadas ao tempero de alimentos (tempero pronto) / Microbiological quality of ready-to-use food seasonings

Cinquenta amostras de misturas prontas destinadas ao tempero de alimentos, denominadas "Tempero pronto", a venda nos supermercados da cidade de Säo Paulo, foram submetidas a análise microbiológica para verificaçäo da presença de bactérias causadoras de toxinfecçöes alimentares e para determinaçäo dos níveis de contaminaçäo por microrganismos deteriorantes. Estes produtos säo compostos principalmente de cebola, alho, tomate, óleo, salsinha, pimentäo e diversos condimentos (sal, pimenta do reino, orégano, entre outros). Em nenhuma das amostras foi detectada a presença de Salmonella sp, Staphylococcus aureus, Escherichia coli (como também coliformes fecais) e clostrídios sulfito-redutores. Bacillus cereus e bolores e leveduras foram detectados em 5 amostras, em níveis inferiores a 300 UFC/g. Bactérias esporulantes anaeróbias também näo foram observadas. As bactérias esporulantes anaeróbias também näo foram observadas. As bactérias aeróbias mesófilas variaram entre 10**1 e 10**5 UFC/g, as bactérias aeróbias termófilas e as bactérias esporulantes aeróbias mesófilas entre 10**1 e 10**4UFC/g