Finding Analysis of Medical Device Manufacturer Audit in Suzhou Industrial Park for the Last Three Years / 中国医疗器械杂志

OBJECTIVE@#Common findings are to be found from 144 different type of medical device manufacturers' audit reports which are from Jan. 2017 to Jun. 2019. Advise is to be provided for medical device manufacturers on continual improvement.@*METHODS@#Classify and analyze the on-site audit findings from different type of medical device manufacturers.@*RESULTS@#The frequency of findings from chapter production management, buildings and facilities, quality control are comparatively high.@*CONCLUSIONS@#The key to improve the quality management system is to cultivate the staff sense of continual improvement of quality system, improve the staff ability of finding and solving problems, encourage staff participation in quality system, fit the quality system on product realization.

A Quality Comparison Between the Precise Powder Decoction Pieces and the Original Slices of Spatholobus suberectus Dunn / 世界科学技术-中医药现代化

In this study,DNA molecular identification technology and chemical fingerprint method were adopted to evaluate the quality system of precise powder decoction pieces (PPDP) of S.suberectus dunn (SSD).ITS2 sequence was taken as DNA barcode to indentify SSD.Different specifications of PPDP were prepared,their dry extract contents were quantified in contrast with that of original slices.Three batches of SSD original slices were gleaned and the content uniformity,fingerprint and similarity evaluation before and after the mixing and pulverization were valued by HPLC-DAD.As a result,ITS2 successfully and accurately identified the SSD in this study.The extract rate of PPDP was 15.5％,1.11 times as much as the original slices.RSD of inter-assay dissolution of cepicatechin from the original slices was 11.0％,which was reduced to 1.0％ after mixing and preparing into PPDP.The relative peak area of the 14 common peaks identified by fingerpringts were larger,while the RSD values significantly decreased.It was concluded that the PPDP of SSD improved the extraction efficiency and uniformity of the original slices,featuring quite prospective in more reasonable and scientific clinical use.

Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories

BACKGROUND: Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. METHODS: We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. RESULTS: Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. CONCLUSIONS: These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing.

Management of drug production process changes based on pharmaceutical quality system / 中国药学杂志

OBJECTIVE: To analyze the key problems in the management of drug production process changes during the drug life cycle, thus to improve the management of pharmaceutical production process changes. METHODS: Taking the change of injection sterilization process as an example, the issues in the study and management of process change were analyzed by employing empirical a-nalysis methods and introducing the concept of equilibrium analysis of the pharmaceutical quality system. RESULTS AND CONCLUSION: The pharmaceutical quality system is the equilibrium system of five aspects, including prescription composition, raw material control, production process, packaging and quality control. Process change research should follow the concept that quality comes from design, use process analytical technologies, and give full consideration to the quality system equilibrium. Process change management needs a systematic management of drugs.

Perfeccionamiento del proceso de servicio posventa / Improvement of the aftermarket service process

INTRODUCCIÓN : la producción de medicamentos requiere de una exigente política de calidad que tenga la finalidad de salvaguardar los intereses del paciente, la sociedad y el Estado. Uno de los procesos más variable dentro del ciclo de vida de un producto y con requisitos muy específicos para el caso de los medicamentos es el servicio posventa. OBJETIVO: perfeccionar el proceso de servicio posventa de los productos para uso humano que comercializa el Centro Nacional de Sanidad Agropecuaria. MÉTODOS: el estudio se sustenta en la aplicación de herramientas de calidad, como son: diagrama causa-efecto, tormenta de ideas, lista de chequeo, representación de los problemas detectados y aplicación de la metodología planificar-hacer-verificar-actuar. RESULTADOS: se logró identificar a los subprocesos de atención al cliente, competencia, distribución, garantía, adiestramiento para el uso, quejas y reclamaciones, retiro de productos y farmacovigilancia como los factores principales que caracterizan al proceso. Se definieron y evaluaron los requisitos de cada uno de ellos; se obtuvo solo el 54,5 por ciento de su cumplimiento. El diseño e implementación de un plan de mejora, permitió el perfeccionamiento del proceso, con un cumplimiento del 100 por ciento de los requisitos diseñados. Destacan el rediseño de las funciones, responsabilidades, interrelaciones, entradas, salidas, recursos, sistema de procedimientos y registros, con énfasis en subprocesos tan específicos y complejos como la distribución, retiro de productos y la farmacovigilancia. CONCLUSIONES: se aportan indicadores para evaluar el desempeño y facilitar la toma de decisiones y administración más eficiente del proceso, que elevan el nivel de satisfacción de los clientes. Estos resultados contribuyen a mejorar el servicio posventa de los productos con interés comercial y al cumplimiento de los requisitos de las buenas prácticas de fabricación de medicamentos(AU)

INTRODUCTION: drug manufacture requires strict quality policies that are aimed at safeguarding the interests of the patient, the society and the state. One of the most variable processes in a product's lifecycle, with very specific requirements in the case of drugs, is the aftermarket service. OBJECTIVE : to upgrade the aftermarket service process for the human use products that the National Center of Agricultural Health markets. Methods: the study was based on the use of quality tools such as cause-effect diagram, brainstorm, checking list, depiction of detected problems and application of the methodology called planning-doing-checking-acting. RESULTS: it was possible to identify the subprocesses of attention to the client, competition, distribution, warranty, training for use, complaints and claims, product withdrawal and pharmacovigilance are the main factors characterizing the process. Requisites of each of them were defined and evaluated, but just 54.5 percent were fulfilled. The design and implementation of an upgrading program allowed improving the process and fulfilling all the planned requisites. There should be mentioned the re-design of functions, responsibilities, interrelations, inputs, outputs, resources, system of procedures and registrations, with emphasis on complex specific subprocesses like distribution, product withdrawal and pharmacovigilance. CONCLUSIONS: some indicators are provided to evaluate the performance and to facilitate decision-making and more efficient management of the process in order to raise the level of satisfaction of the client. These results contribute to improve the aftermarket service of products and the compliance with the good practice requirements in the drug manufacture(AU)